Acceptance Criteria

Specified indicators or measures employed in assessing the ability of a component, structure, or system to perform its intended function.

Active Packaging

Active Packaging does not use any phase change materials (PCM) such as water/ice or dry ice. These systems use mechanical or electric systems powered by an energy source, combined by thermostatic control to maintain proper product temperatures.  

Active Thermal System

See Active Packaging.

Adhesive

A material that bonds together the surfaces of similar or different materials.

Allowable Excursions

Acceptable range in which the product temperatures can reach within a set amount of time that does not compromise the integrity of the product.

Ambient Monitored

This is the normal storage requirement for most pharmaceuticals and medical devices and involves controlled range usually below 25C or a maximum temperature of 30C.  Source: HQMS AA-4 08, PharmaJ 2001: 267: 128-131, WHO TRS 908 Annex 9 Appendix

Ambient Temperature

The temperature of an outside environment.

Anvisa

The institutional purpose of this agency is to foster protection of the health of the Brazilian population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. In addition, the Agency exercises control over ports, airports and borders. Anvisa also liaises with the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance.

API

Active Pharmaceutical Ingredient - Any substance or mixture of substances intended to be used in the manufacture of a drug product and that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment or prevention of diseases, or to affect the structure and function of the body.  Source: Guidelines for Good Distribution Practice

ASTM

American Society for Testing and Materials

ASTM D-3101

ASTM Industry Standard Test Method for Thermal Insulation Quality of Packages.

ATMP

Ambient Temperature Mapping Profile - A systematic process for evaluating the distribution environment can to develop a statistically relevant temperature profile that meets regulatory, logistics, and performance requirements. The temperature profile study is done by using the LifeConEx LifeTrack IT platform together with data loggers.  LifeConEx also collects and analyzes the data, and issues its final report.

Audit

An independent and objective activity designed to add value and improve an organization's operations by helping to accomplish its objectives by using a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes.  Source:  WHO TRS 937 Annex 5

Bag

A non-rigid container used for holding product.

Barrier

A material that blocks the transfer from one area to another.

Batch

A defined quantity of pharmaceutical products processed in a single process or series of processes so that it is expected to be homogeneous.  Source:  WHO TRS 937 Annex 5

Batch number

A distinctive combination of numbers and/or letters which uniquely identifies a batch, for example, on the labels, its batch records and corresponding certificates of analysis.  Source:  WHO TRS 937 Annex 5

Benchmark

A point of reference from which measurements may be made.

Bill of Materials (BOM)

A listing of components, including descriptions and/or item numbers.

Biological

A preparation, such as a drug, a vaccine, or an antitoxin, that is synthesized from living organisms or their products and used medically as a diagnostic, preventive, or therapeutic agent.

Biotechnology

Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts.

Biopharmaceutical (linked to Biopharmaceutical and Biopharmaceuticals)

Biopharmaceuticals are medical drugs (see pharmacology) produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.

Biosimilar

or "Follow-on Biologic" refers to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.

BLA (Biologic License Application)

An application to the FDA to request permission to market a biologically derived pharmaceutical product based on all of the available.

Blinding

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).  Source:  WHO TRS 937 Annex 5  

Bricks

Refrigerants that remain uniform in shape while frozen or thawed.

Broker

A person or an entity whose activity involves the broker entering into a contract with a person or entity whereby the broker receives a commission for any business he brings to the person or company calculated as a percentage of the transaction between that entity and a third party.  However, the broker normally does not actually take physical control of the medicines.  Source:  WHO TRS 937 Annex 5

C Service (Critical)

When your first ship date is rapidly approaching and a working Standard Operating Procedure (SOP) is adequate for your type of product, LifeConEx C Service is the way to go. A working SOP and incident report are available. The C Service requires a minimum of 3 business days for implementation prior to the first ship date of your product.

Calibration

The tuning of an instrument according to a standard value.

Calibration Verification

The act of confirming that a device or instrument is properly calibrated.

Cardboard

A thick paper-based material.

Carrier

Provides transport services for traveling passengers and/or freight.

Carry Paks

A thermal container system with a handle that makes personal transportation easy and efficient. Ideal for medical samples, food, perishables, or valuables (also called carry packs).

CFC

Chlorofluorocarbons - a refrigerant known to cause depletion of atmospheric ozone.

CFR

Code of Federal Regulations

CFR (21) Part 11

Federal regulations stating that electronic records and signatures are considered equivalent to paper records.

cGMP

Current Good Manufacturing Practices

Chamber Controller

An electronic instrument used to regulate the ambient temperature of an environmental chamber.

Change Control

Process, authorities, and procedures used for all computerized or system data changes.  Change control should be in place to ensure that changes are reviewed for potential impact upon the quality of the product or upon the quality system.  Source: WHO TRS 937 Annex 5, 12.2.  EU GMP Part 1, 8, ICH Q10 3.2.3

Chart Recorder

An electronic instrument that records the ambient temperature of an environmental testing chamber.

Chilled

Usually products in this category need to be stored and distributed at 2° and 8° C.  The building or fridge should be alarmed so that potential deviations can be acted upon.  Appropriate insulation and access control should be in place so that temperature fluctuations do not occur.  Source:  EU GMP 1 3.3, PIC/s PE009-7 Part I 3.3, HQMS AA-4 08

Clinical Investigation

Any experiment in which a drug is administered or dispensed to or used involving one or more human subjects. For the purpose of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. (FDA Regulation 312.3, Investigation New Drug Application).

Clinical Research

Patient oriented research including epidemiology (retrospective, cross-sectional, or prospective study of disease(s) in populations), and studies of behaviors, outcomes, and health services.

Clinical Site

A clinical site is a medical facility staffed with a clinical investigator (MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to.

Clinical Trial

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or pharmacodynamic effects of an investigational product with the object of determining safety and/or efficacy." (ICH GCP, International Conference on Harmonization / WHO Good Clinical Practice Standard)

Clinical Trial Volunteer

Individuals who are participating in a clinical research study.

CO2 Emissions

Carbon dioxide (CO2) is emitted in a number of ways. It is emitted naturally through the carbon cycle and through human activities like the burning of fossil fuels.

Cold

Any temperature not exceeding 8° C; (46° F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° C; and 8° C; (36° and 46° F). (USP 797)

Cold Chain Analytics

A solution that drives the day-to-day retrieval, storage, compilation, analysis and reporting of your cold chain data. Temperature data, gathered from your cold chain, is translated into pertinent, meaningful information that allows managers to reduce costs, improve quality and increase profitability.

Cold Chain Management

Management of all phases of the cold chain, including products in transit, in process, in storage, and in display.

Cold Chain Network

See Cold Chain.

Cold Chain Packaging Consultant

An individual with expertise in the area of cold chain packaging.

Cold Chain Product

A product that is temperature sensitive.

Cold Chain Solutions

Are designed to achieve the goal of consistently having temperature-sensitive medicinal products in the right place, at the right time, and in the right condition, through the integration of monitoring, and tracking and tracing, with an emphasis on driving measurable process improvement from the information.

Cold Chain Storage Consulting

Advice from an expert in the design and application of cold chain solutions.

Cold Chain

Refers to a time and temperature controlled transportation for temperature sensitive products from the manufacturer to the end user.  Source: PDA PCCIG EU Branch Lead, Berlin PDA 2010

Conditioning

see Pre-conditioning.

Conductive Heat Transfer

Having the quality or power of conducting heat or electricity or sound; exhibiting conductivity.

Consignee

In a contract of carriage, the consignee is the person to whom the shipment is to be delivered to whether by land, sea or air.

Container

The material employed in the packaging of a pharmaceutical product.  Containers include primary and secondary containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product. Source: WHO TRS 937 Annex 5

Contamination

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter during manufacturing, sampling, packaging or repackaging, storage or transport. Source: WHO TRS 937 Annex 5

Contingency Planning

One of the fundamental aspects of LifeConEx Process Management. Multiple storage and distribution options are built into the cold chain to ensure an uninterrupted process which maintains a given temperature range.

Controlled Ambient Temperature

Some regions and products need both monitoring and control because of severe temperature fluctuations.  Controlled ambient is understood as between 15C and 30C and needs to be validated. Source:  EU GMP Part 1  3.19, HQMS AA-4 08, Pharma 2001:  267: 128-131

Controlled Drug Storage

An additional license is required to store controlled drugs.  A separate secure storage area should be provided which is designed to meet local regulatory security requirements.  Source:  HQMS AA4-10, INCB Yellow & Green Lists

Controlled Room Temperature (CRT)

A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77° F); that results in a mean kinetic temperature calculated to be not more than 25C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours. Spikes above 40°C may be permitted if the manufacturer so instructs. Articles may be labeled for storage at "controlled room temperature" or at "up to 25°C", or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variations.  (Source: USP 797)  

Convective Heat Transfer

Caused or accomplished by convection; as a convective discharge of electricity.

Cool

Any temperature between 8° C; and 15° C; (46° and 59° F). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.  (Source: USP 797)  

Corrective Action

Is taken to eliminate the cause of a detected non-conformity or other undesirable situation.

Corrective Action Preventive Action (CAPA)

focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions to be undertaken.  A formal written response must be made by the facilities audited on all observations within 30 days.  CAPA is part of the overall quality management system (QMS) at LifeConEx called - LifeControl.Source:  Good Manufacturing Processes, ISO 13485:20038.3, ICH Q10 3.2.2, FDA 21 CFR 820.90

Corrugate

Refers to the alternating ridges and grooves in a cardboard carton.

Counterfeit Medication

Product or cosmetic which is deliberately and fraudulently mislabeled with respect to identify and/or source. Counterfeiting can apply to both branded and generic products/cosmetics and may include products / cosmetics with the correct ingredients or with wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.  Source: Guidelines for Good Distribution Practice

Cross-contamination

Contamination of a starting material, intermediate product or finished product with another starting material or product during production.  Source:  Source:  WHO TRS 937 Annex 5

Customs

Each country's department that reviews in-coming materials, including clinical trials materials. The area at a port, airport, or border where baggage and freight are examined for duty status.  Care must be taken with temperature sensitive materials and prior notification should be provided so that speedy clearance can be obtained and if necessary the correct storage conditions provided for at the point of entry.  Source:  EU GDP (94/C – 63/03) 21,  WHO TRS 937 Annex 5 18.6

Dangerous Goods

Are defined as articles or substances which are capable of posing a risk to health, safety, property or the environment which meet the criteria of one or more of nine UN hazard classes and, where applicable, to one of three UN Packing Groups according to the provisions of Section 3 of the International Air Transport Association.  Source:  IATA Dangerous Goods Regulations 50th Edition

Data Acquisition Units (DAU)

A calibrated device that logs data acquired from an electronic unit.

Data Logger

An in-transit temperature recorder that measures temperature during a specified time period (also called a digital data logger, data monitor, temperature data logger, in-transit temperature recorder).

Denaturation

Is a process in which proteins or nucleic acids lose their tertiary structure and secondary structure by application of some external stress or compound, such as heat. If proteins in a living cell are denatured, this results in disruption of cell activity and possibly cell death. Denatured proteins can exhibit a wide range of characteristics, from loss of solubility to communal aggregation.

Design Development/Design Evaluation (Pre-qualification) (n=1)

Design phase in which shipping systems (shipping containers, insulation, refrigerants) are tested to evaluate its performance.

Design Evaluation (DE) or Pre-qualification Testing (PQ)

A detailed evaluation, and development of a thermal package design that is tested for its performance under simulated conditions.

Design Evaluation

A detailed review of an existing shipping container system.

Deviation

Any quality event with potential impact on product quality which requires an investigation which includes the following events

• Product, packaging or labeling mix-up involving the product
• Potential counterfeit product(s)
• Probable or known contamination of a product with another product, extraneous foreign material or micro-organisms.
• Batches subject to a major malfunction of equipment or a facility utility system including HVAC, water, sprinkler, plumbing, fire protection, and electrical.
• Batches subject to natural disasters or acts of God such as flooding, fire, earthquake, lightning strike.
• Batches requiring a formal investigation for reconciliation discrepancy
• Product stored outside the established environmental storage conditions (e.g. temperature and humidity).
• Non-conformance with applicable laws and regulations.  Source:  WHO TRS 937 Annex 5

Die-Cut

A process by which a box is cut to create a customized product.

Dimensions

Description of an object in physical terms (e.g., length x width x depth, or length x width x height).

Discrepancy

An inconsistency between facts or sentiments.  For example, they found a discrepancy between the first set of temperature data logger results and the second.  Throughout the cold chain, physical actions must be consistently be matched with temperature readings to determine discrepancies.  

Distribution

The division and movement of pharmaceutical products from the premises of the manufacturer of such products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via storage and/or health establishments.  Source:  WHO TRS 937 Annex 5  

Distribution Process

The process by which product moves from the point of manufacturing to the end user. This may include 3PL (third party logistics), freight forwarders, freight consolidators, wholesalers and expedited shippers.

Distribution Temperature

Specified temperature at which a product must be distributed.

Double-blind Trial

In a double-blind or double-masked study neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are receiving either a standard treatment or a placebo. These studies are performed so that neither the patients nor the doctors expectations about the experimental drug can influence the outcome.

Double Wall Corrugated Board

A box made by joining three flat facings and two intermediate corrugated parts. This box is usually stronger than a single wall corrugated box.

DRA

Drug regulatory authority:  National authority responsible for the regulation of medicinal products.  Source:  WHO TRS 937 Annex 5

Drug product

A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients.  The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.  Source:  WHO TRS 937 Annex 5

Dry Ice

A refrigerant that is solid carbon dioxide, which sublimates to a gas at very cold temperatures. Dry ice is used as a pharmaceutical coolant in insulated/thermal packaging.

Dry Place

The term "dry place" denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity. Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place. There are no hard and fast temperature or humidity requirements for cleanrooms.  Ideally, the controlled compounding rooms should be 66F +/-2 F to ensure employee comfort when fully garbed.  Relative humidity (RH) recommendations should be between 30 and 65 % RH. 

Dunnage

Padding used to fill empty space in a shipping container.

Duration

A length of time, i.e., a 24-hour minimum post stabilization or until stabilization occurs at the specified temperature.

E-Pedigree

An electronic record that traces the ownership and transactions of a prescription drug product as it moves among various trading partners – from the manufacturer to the pharmacy, hospital or other healthcare entity.  The primary purpose of an e-pedigree is to protect consumers from contaminated medicine or counterfeit drugs.  WHO TRS 937 Annex 5

Efficacy

The ability to produce a desired outcome.  

EMEA

European Medicines Agency - is a European agency for the evaluation of medicinal products, roughly parallel to the U.S. Food and Drug Administration (FDA).

End-to-End

End to end solutions designed to process the logistics requirements from manufacturer to wholesaler/distributor to retailer.

Environmental Chamber

A thermally isolated chamber typically capable of maintaining temperatures within a minimum and maximum (e.g., -30°C to 85°C) by means of a programmable controller. A quality environmental chamber is one that is capable of maintaining its controlled temperature throughout the entirety of the chamber without drop offs or hot pockets. Additionally, a quality chamber must be draft free, preventing direct air blowing upon the tested product.

EPA

Environmental Protection Agency - is an agency of the federal government of the United States charged with protecting human health and the environment, by writing and enforcing regulations based on laws passed by Congress.

EPS

Expanded polystyrene - a lightweight, cost effective, cushioning insulating material used in packaging for temperature-sensitive goods.

EFGCP

European Forum for Good Clinical Practice - is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe.

Eucomed

Is the representation of the medical technology industry in Europe.  Source:  WHO TRS 937 Annex 5

Eutectic Mixture

A mixture of two or more substances with a melting point lower than that of individual substances.

Eutectic Point

A eutectic point is the temperature that is maintained as the mixture of Phase Change Materials transforms from solid to liquid (or vice versa).

Excipient

A substance or compound, other than the active pharmaceutical ingredient and packaging materials, that is intended or designated to be used in the manufacture of a pharmaceutical product.  Source:  WHO TRS 937 Annex 5

Excessive Heat

Any temperature above 40° C; (104° F).  (Source: USP 797)

Excursion

Deviation from a specified limit.

Excursion Limit

A defined allowable deviation from a specified limit.

Expanded Polystyrene (EPS) Manufacturer

A company that manufactures EPS.

Expiry date

The date given on the individual container (usually on the label) of a product up to and including which the product is expected to remain within specifications, if stored correctly.  It is established for each batch by adding the shelf-life to the date of manufacture.  Source:  WHO TRS 937 Annex 5  

Exposure

The condition of being exposed, uncovered, or unprotected.  This represents a deviation to the cold chain.

External Temperature Cycle

The ambient temperature that the shipping container witnesses for each step of the transit process (packaging, warehouse, transit, etc.).

External Temperature Profile

Refers to the ambient temperature that the shipping container witnesses during its transit process. There are a number of acceptable means by which the ambient profile can be determined (summer highs, winter lows).  Please see ATMP for more details.

FDA

United States Food and Drug Administration - The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

Film

A non-fibrous, flexible material used to encase a refrigerant gel or refrigerant brick.

Final Qualification

Upon completion of an acceptable design, the Final Qualification is performed demonstrating reproducibility (often at n=3). The final qualification includes all data, certifications, and proof of validated equipment necessary for the rigorous review of a full audit.

Finished Product

A product that has undergone all stages of production, including packaging in its final container and labeling.  Finished products must only be distributed to persons or entities that are licensed to acquire such products to applicable legislation.  Source: Guidelines for Good Distribution Practice

Freezer

A place in which the temperature is maintained thermostatically between  -25° C; and -10° C; (-13° and 14° F).  Source:  USP 797

Forwarding agent

A person or entity engaged in providing, either directly or indirectly, any service concerned with clearing and forwarding operations in any manner to any other person and includes a consignment agent.

Freight Forwarder

See Forwarding agent.

GCP

Good Clinical Practice - is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

GDP

Good Distribution Practice - deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.  GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

GEP

Good Engineering Practice – around clean-rooms and zones around ISO 14644 becoming more prevalent with associated systems and validation.

Gel Bottles

Heavy-duty refrigerants that feature a tough, puncture-proof, blow-molded high-density plastic bottle. Ideal for rough environments or reuse.

Gel Paks

Refrigerants available in a variety of pouch materials, freezing points, gel structures, and in a saddlebag design (compartmentalized gel packs that wrap around the uneven contour of the payload) Also called gel packs, gel paks, blue ice, refrigerant packs, gel refrigerants, ice substitute, food ice pack, ice bricks, ice packs, and saddlebag refrigerant.

Generic Drug/Medication

Are equivalent medicines demonstrating the same quality, safety and therapeutic efficacy as the originator product.  They contain the same active substance under the same pharmaceutical form as the originator, and are marketed after patent expiry.  Generics are usually cheaper than the originator, depending on national pricing policy and that of originators when facing price competition.  Source:  WHO TRS 937 Annex 5

GHTF

Global Harmonization Task Force - was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. This is being done with two aims in mind: enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world.  A partnership between regulatory authorities and regulated industry, the GHTF is comprised of five Founding Members: European Union, United States, Canada, Australia and Japan.

GLP

Good Laboratory Practices - specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) safety and efficacy tests.

GMP

Good Manufacturing Practice - is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms of drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidance that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation, basic concepts of all these guidelines remains more or less similar that is ultimate goal to safeguard the health of the patient, producing a good quality medicine or medical devices or active pharmaceutical products.

Ground Handling Agent

Defines the servicing of an aircraft while it is on the ground and (usually) parked at a terminal gate of an airport.  Many airlines outside the United States subcontract ground handling to an airport or a handling agent, or even to another airline. Ground handling addresses the many service requirements of an aircraft between the time it arrives at a terminal gate and the time it departs on its next flight. Speed, efficiency, and accuracy are important in ground handling services in order to minimize the amount of time the temperature-sensitive product is unloaded from the plane and placed in appropriate storage conditions.

GSP

Good storage practices – this guide is intended for those involved in the storage, transportation and distribution of pharmaceuticals. It is closely linked together existing guides recommended by the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

GPS

Global positioning systems, normally satellite-based.  Source:  WHO TRS 937 Annex 5

GxP

Is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries. The titles of these good practice guidelines usually begin with "Good" and end in "Practice", with the specific practice descriptor in between. GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor.

H2 Cargo

LifeConEx offers a reliable, integrated end-to-end service with ocean carriers.  This service proactively monitors every refrigerated container throughout the defined process, identifies the risk points in multiple handovers, and intervenes at any time.

HACCP

Hazard Analysis and Critical Control Point

Handover Point (linked to Handovers)

The point of physical handover of goods that occurs between multiple entities of the cold chain in various locations along each trade lane.

Hazardous

Is defined as a possible source of danger with a chance of an accident or a chance of being injured or harmed.  There are nine classes which relate to the type of hazard whereas the packing groups relate to the applicable degree of danger within the class.  Source:  YB Section 18.5

HCFC

Hydrochloroflurocarbons - a class of refrigerants that have often replaced CFCs. HCFCs are known to deplete atmospheric ozone, but to a lesser extent than CFCs.

HCPC

Healthcare Compliance Packaging Council

Heat Sealing

Sealing together two or more layers of film under high temperature and pressure to create a secure seal. Heat sealing is used in refrigerant gel packs and refrigerant bricks.

Half Slotted Carton

A half slotted carton, applies to corrugate containers.

Healthcare entity

Is the whole or part of a public or private facility, building or place, whether operated for profit or not, that is operated or designed to provide health care services such as diagnostic, medical, dental treatment or chronic or rehabilitative care including the supply of pharmaceutical products to the end user, but does not include a retail pharmacy or any wholesale distributor.  Source:  WHO TRS 937 Annex 5

Hybrid Packaging

Hybrid packaging uses a combination of phase change materials (PCM) such as water/ice or dry ice and thermostatic controls. These systems typically use the PCM's as a source of energy, which is regulated by some type of thermostatic control to maintain proper product temperatures.

Hybrid Thermal System

See Hybrid Packaging.

Human Subject Research

Research involving the behavioral and/or biomedical assessment of treatment of patients, including study of their tissue, specimens, medical records, genetic material.

IATA

International Air Transport Association - is an international trade body, created over 60 years ago by a group of airlines. Today, IATA represents some 230 airlines comprising 93% of scheduled international air traffic. The organization also represents, leads and serves the airline industry in general. 

IATA Ch. 17

the International Air Transport Association (IATA) has added a chapter to the 7th Edition of the Perishable Cargo Regulations effective July 1, 2007. The 23 page Chapter 17 is dedicated to air transportation for temperature-sensitive healthcare products.  The purpose of this chapter is to provide information on the factors that affect temperature-sensitive healthcare products and to indicate critical control points in the air transport logistics that can impact these sensitive products and to provide best practices conforming to regulatory agencies requirements.  Source:  IATA Ch. 17

IATA Time and Temperature Sensitive Label

The Time & Temperature Sensitive Handling Label usage is specific to the healthcare industry. It was first introduced in Chapter 17 of the 9th Edition of the IATA Perishable Cargo Regulations (effective July 1, 2009), as an optional label to be used in conjunction with a Quality Management System between the shipper, freight forwarder, airline carrier and others in the distribution chain.

IATA Time and Temperature Task Force

The IATA Time and Temperature Task Force (TTTF) is mandated to develop and maintain standards for the procedures, documentation, cargo handling, packaging and acceptance of goods from the health care sector in order to facilitate, improve or maintain the logistics thereof. It shall act as the liaison with all stakeholders from the health care industry or their intermediaries.

ICE (Investigation of Carrier Error)

These are carrier-specific investigations undertaken by the LifeConEx Quality team dealing with any potential product deviations (e.g. from controlled temperature, storage conditions, cleaning requirements, or procedure).  The root cause of the deviation is determined and corrective actions put in place to prevent re-occurrence.Source: WHO TRS 937 Annex 5, 12.14 – 14.5, FDA 21 CFR 820.198, ISO 13485: 2003 8.3

ICH

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.  The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration.

IDE (Investigational Device Exemption)

An application to FDA to request permission to conduct human testing of unapproved devices.

Immediate Packaging

The container or other form of packaging immediately in contact with the medicinal or investigational medicinal product.  Source:  WHO TRS 937 Annex 5

Implementation (linked to implement and implementation)

The systematic review and approval of each SOP, trade lane by trade lane, by each respective supply chain partner within what cold chain.  These processes are stored in the LifeConEx LifeTrack IT system.

Importation

The act of bringing or causing any goods to be brought into a customs territory (national territory, excluding any free zone).  Source:  WHO TRS 937 Annex 5

INCB

The International Narcotics Control Board is the independent and quasi-judicial control organ monitoring the implementation of the United Nations drug control conventions.

Incident Report

Inquiry conducted in case of deviation to the LifeConEx Working SOP or Process Map.  

INCOTERMS

Incoterms or International Commercial terms are a series of pre-defined commercial terms published by the International Chamber of Commerce (ICC) widely used in international commercial transactions. A series of three-letter trade terms related to common sales practices, Incoterms are intended primarily to clearly communicate the tasks, costs and risks associated with the transportation and delivery of goods.  Source:  WHO TRS 937 Annex 5

IND

Investigational New Drug

INDA (Investigational New Drug Application)

An application to the Food and Drug Administration (FDA) by a drug sponsor in which permission is requested for the human testing of the drug product, which is called the investigational new drug. Prior to initiating Phase I for a clinical trial, the applicant must submit a detailed protocol, preclinical data, and investigator credentials.

Innovation

The development and introduction of new ideas, goods, and services.

Intermediate

A material produced during the processing step of an API which must undergo further molecular change or purification before it becomes an API.  Source: Guidelines for Good Distribution Practice

Intervention Management

These are the actions taken by the LifeConEx Life Science Service to address deviations to the implemented SOP.  These may include but are not limited to: Offloaded shipments, misrouted shipments, improper documentation, damaged or malfunctioning cool containers, or incorrect temperature settings.

Investigational Product

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authori

Investigation Report

Report conducted by the LifeConEx Quality team which supports the regulatory compliant SOP and release of product in case of deviation to the process.  This involves a complete review of each supply chain entities processes when a deviation to the LifeConEx SOP is reported on a trade lane.  Corrective and preventive actions are identified and implemented for that SOP covering that trade lane.  

IPIC

International Pharmaceutical Industry Congress

IQ/OQ/PQ

Installation Qualification, Operational Qualification, Performance Qualification

ISO

International Organization for Standardization - is the world's largest developer and publisher of International Standards.  ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO 9001:2000

The International Organization for Standards' Quality Management System for accreditation of quality control for manufacturers.

ISPE

International Society for Pharmaceutical Engineering

ISTA

International Safe Transit Association - provides programs, services and activities that assist in packaged-product distribution.

ISTA 1A

ISTA's basic requirements for fixed displacement vibration and shock testing.

ISTA 2A

ISTA's basic requirements for atmospheric conditioning, compression, fixed displacement or random vibration and shock testing.

ISTA 5B

ISTA's focused simulation guide for thermal performance testing of temperature controlled packaging and thermal boxes.

ISTA 7D

Is a development test to evaluate the effects of external temperature exposures of individual packaged products shipped through a parcel delivery system.

ISTA 7E

Refers to a set of thermal shipping profiles. The 7E Converter is a program that allows companies to enter their current data, click a button on their computer, and receive a prediction of thermal performance of their ISC against the new profiles.

Japan Ministry of Health

This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.

KFDA

Korean Federal Drug Administration - oversees the safety and efficacy of drugs and medical devices in South Korea.

KPI

Key Performance Indicators – these cover such areas as improvement initiatives, percentage on time, quality failures, investigations, customer complaints and response times, internal audit observations, staff training status, equipment breakdowns and controlled document review.  Source: HQMS AA4-09, ICH Q101.5.3, DSC PtQ KE 02

Labeling

The term "labeling" designates all labels and other written, printed, or graphic matter upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container. A shipping container, unless such container is also essentially the immediate container or the outside of the consumer package, is exempt from labeling requirements.  Source: Guidelines for Good Distribution Practice

LD3 and LD9

Designation for metalized containers capable of holding one and four U.S. sized pallets, respectively.

LCCSP

Lead Cold Chain Solutions Provider – an organization with processes built upon the foundation of the forwarder and airline as it applies to the cold chain.  These providers understand the critical and complex supply chain needs of the biopharmaceutical industry and have designed solutions to meet those needs.  

"LifeConEx It"

This is the LifeConEx process methodology.  Those utilizing LifeConEx services may be assured of their product integrity and do not have to worry.  It's all about patient safety.

Life (L Service)

When you need to establish and audit-ready, regulatory compliant Standard Operating Procedure.  Through the LifeConEx Quality team, an investigation report with Corrective Action Preventive Action is available upon request.  The L Service requires a minimum of 10 business days for implementation prior to the first ship date of the product.

Life Sciences

The life sciences comprise all fields of science that involve the scientific study of living organisms, like plants, animals, and human beings.

Life Science Service Center

The LifeConEx team of 24/7/365 end-to-end process management professionals dedicated to providing detailed in-transit email updates and consistent intervention management to enact contingency planning when there are deviations to the SOP.

LifeTrack

LifeConEx exclusive integrated data portal which enables Life Science organizations to automate and streamline their entire cold chain networks.  

LifeControl

The LifeConEx Quality Policy.  The goals are patient safety, product integrity, regulatory compliance, process optimization, and cost optimization.

Logistical Challenge

The requirement to ensure that a product will travel through the distribution system(s) as needed and designed.

Logistics Provider

A person or entity that provides logistics services for part or all of the supply chain management functions for other entities (manufacturers or suppliers).  Third party logistics providers are typically specialized in integrated warehousing and transportation services that can be customized according to the demands and delivery requirements of their customers.  A logistics provider does not hold proprietary rights over the medicines they store and distribute.  WHO TRS 937 Annex 5  

Lyophilized Product

A material that is freeze-dried.

Manufacture

All operations of purchase of materials and products, production, packaging, labeling, quality control, release, storage and distribution of pharmaceutical products, and the related controls.WHO TRS 937 Annex 5

Manufacturer/importer of Investigational Medicinal Products

Any holder of the authorization to manufacture/import referred to in Article 13.1 of Directive 2001/20/EC.  WHO TRS 937 Annex 5

Material

A general term used to denote starting materials (active pharmaceutical ingredients and excipients) reagents, solvents, process aids, intermediates, packaging materials, and labeling materials.  WHO TRS 937 Annex 5

Maximum Packout

Package configuration that includes the maximum amount of product to be utilized within the shipping system.

Medical Device

Device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention, and which is intended to remain after the procedure.  WHO TRS 937 Annex 5

Medicinal Product

Drugs (e.g. pharmaceuticals and medical devices).  WHO TRS 937 Annex 5

MHRA

The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the U.K. Department of Health.  

Minimum Packout

Package configuration that includes the minimum amount of product to be utilized within the shipping system

Molded Shipping Container

A one piece construction product produced under pressure and heat in a forming tool. Container may have a second molded part for a lid.

MSDS

Material Safety Data Sheet

Mode (of transportation) (linked to Mode and Modes)

Is a term used to distinguish substantially different ways to perform transport. The most dominant modes of transport are aviation, land transport, which includes rail, road and off-road transport, and ship transport.

n = 3

The number of tested shipping systems (including the product load and refrigerants) per design. In this case, the number is three.

NDA (New Drug Application)

An application to the FDA in which the study sponsor seeks permission to market a drug, based on all data known about the drug.

Needs Assessment

Scope of work required to meet a particular objective, and preparation of budget estimate.

NDE (New Device Exemption)

An application to the FDA in which the study sponsor seeks permission to market the product based on all known data.

NIST

National Institute of Standards and Technology, a government agency that sets standards (including temperature).

Non-Conformance

A failure to conform or act in accordance with established standards.

Nutraceutical

Is a food or food product that provides health and medical benefits, including the prevention and treatment of disease.

ODC

Ozone Depleting Chemicals - Chemicals that are known to be harmful to the atmospheric ozone layer (e.g., CFCs, HCFCs).

Order

Instruction to process, package, and/or ship a certain number of units of investigational medicinal product(s).  WHO TRS 937 Annex 5

Outer Packaging

The packaging into which the immediate container is placed.  WHO TRS 937 Annex 5

Over the counter

Medicinal products dispensed without a prescription.  WHO TRS 937 Annex 5

Packaging Type (linked to Packaging Type and Packaging Technologies or Packaging Technology)

Three basic types of cold chain packaging systems are available: active, passive and hybrid. 

Packaging Selection Criteria

When selecting the best packaging for your product, the following factors must be analyzed: active versus passive, size and shape, payload, thermal test profile, test equipment calibration, position and type of refrigerant, package equilibration period.  Source:  PDA PCCIG EU Branch Lead, Berlin PDA 2010

Packout (Pack-out)

The steps and procedures necessary to assemble a shipping container with its refrigerants, buffering materials, and product payload.

Pad

A material used to add protection and minimize shock between layers of products within shipping container, or between containers (e.g., corrugated or solid fiberboard, EPS).

PAHO

The Pan American Health Organization is an international public health agency with more than 100 years of experience in working to improve health and living standards of the countries of the Americas. It serves as the specialized organization for health of the Inter-American System. It also serves as the Regional Office for the Americas of the World Health Organization and enjoys international recognition as part of the United Nations system.

Pallet Shipper

Thermal shipping unit designed to hold an entire pallet.

Passive packaging

Passive packaging commonly use phase change materials (PCM) such as water/ice or dry ice. These shipping systems are the most basic and cost effective.

Passive Thermal System

See Passive Packaging.

Patient

A patient is any recipient of medical attention, care, or treatment. The patient is most often ill or injured and in need of treatment by a physician, veterinarian or other health care professional, although one who attends a physician's visit for a routine check-up may also be viewed as a patient.

Payload

The contents of an inner container (e.g., pharmaceutical products).

PCM

Phase Change Material - A material that changes phases from solid to liquid (or liquid to gas) at a single temperature. Phase Change Materials are either salt or organic based and are capable of changing phases from below -50°C to over 100°C.

PDA PCCDG

PDA Pharmaceutical Cold Chain Discussion Group - is an informational exchange group that educates its members on global shipping and distribution of temperature-sensitive medicinal products through trade and regulatory organizations. This group also develops guidelines and proposes standards for validation of shipping and distribution of the products.

PDA

Parenteral Drug Association

PET

Polyethylene (PET) - A plastic material used in the manufacture of some gel packs.

Pharmaceutical product

Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.  WHO TRS 937 Annex 5

Pharmaceutical Industry

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs.

Pharmacology

Is the branch of medicine and biology concerned with the study of drug action.

Pharmacovigilence

Is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbals, and traditional medicines with a view to identify information about potential new hazards and prevent harm to patients.  WHO TRS 937 Annex 5

Phase I Clinical Trial

A clinical trial that is performed to determine how the drug affects the human body, how much medicine is safe, and how the drug should be administered. Phase I trials may involve a small number of patients (usually 15 to 30) with the disease under study or healthy human volunteers.

Phase II Clinical Trial

A clinical trial that provides information about how well a drug works, and generates more information on its safety and benefit. Generally 100 to 200 take part in Phase II trials.

Phase III Clinical Trial

A clinical trial conducted to determine whether the current treatment practice is the best way to treat a patient, or better treatment would be provided by a new drug treatment. Phase III trials compare a new drug, combination of drugs, device, or procedure with a current standard of treatment. Phase III clinical trials involve approximately 1,000 to 3,000 people nationwide or worldwide.

Phase IV Clinical Trial

A clinical trial in which further evaluation is conducted on a drug has received approval from the FDA.

Phase Change

A change from one physical form to another at a specific temperature.

Polyurethane Insulated Panel

A flat piece of polyurethane designed to fit as a panel in a temperature-sensitive container (also called rigid thermal protection, rigid foam board insulation, rigid polyurethane foam sheet, rigid urethane foam, foam insulation panel, panel sheet insulated containers, expanded packaging polystyrene).

Protection from Freezing

Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the article from freezing.  (Source: USP 797)

Pre-conditioning

Temperature stabilization of a material per requirements (e.g., freezing a gel pack) prior to pack out.

Pre-qualification Testing (PQ) or Design Evaluation (DE)

The initial development of a thermal package design based on the needs assessed by the user.

Pre-qualification (linked to pre-qualified)

A preliminary study, which is generally the first test taken to ensure that a package will meet the objectives in the Final Qualification study.

Pre-Test Conditioning

Storage temperature prior to packout and shipment.

Preventive Action

Is different from corrective action in that corrective action is taken to prevent reoccurrence whereby preventive action is taken to prevent occurrence.  There are two aspects to preventive action.  The first is risk assessment and the second is continuous improvement.

Primary Packaging

The packaging having direct contact with a medicinal product.  WHO TRS 937 Annex 5

Process Mapping

LifeConEx analysis and design of each cold chain process per individual trade lane.  Access to LifeConEx LifeTrack Shipment Tracking Module for Process Updates is a part of this Expedited (X service).

Product

A drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose; or a drug to be used as an ingredient of a preparation for medicinal purpose.  Source: Guidelines for Good Distribution Practice

Product Recall

Is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product.  The recall might be initiated by the manufacturer, importer, wholesaler, distributor, or responsible agency.  Especially with respect to counterfeit medicines emergency recall procedures might apply.WHO TRS 937 Annex 5

Product Stability

The capacity of a drug substance or drug product to remain within specification established to ensure its identity, strength, quality, and purity.  Source:  FDA Guidance for Industry:  Stability Testing of Drug Substances and Drug Products

Product Stability Profile

Throughout a study, a product stability profile is created which shows the behavior of substance over time when correctly stored or transported.Source:  FDA Guidance for Industry:  Analytical Procedures and Methods Validation  

Protocol

Detailed instructions and requirements used in the execution of a test and/or procedure (e.g., qualification testing).

Prototype

A full-scale model or example of a new product prior to its final design.

PUR

Rigid Polyurethane containers for the safe shipment of temperature-sensitive products.

Quality Agreement

Also referred to as Technical Agreements, should be in place to document relationships between customers and suppliers.  These agreements should document the service level, communication between the two parties, and the mode of action following incident, complaint or recall.  The agreements should document the action required if a regulatory inspection is being undertaken.  Source: WHO TRS 937 Annex 5, 4.8.  ISO 13485: 2003 7.2.4

QA

Quality Assurance – is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.  It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.  Source:  WHO TRS 937 Annex 5

QC

Quality Control – covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials, and finished pharmaceutical products conform with the established specifications for identity, strength, purity, shelf-life, storage conditions and other characteristics.  Source:  WHO TRS 937 Annex 5

Quality Management System (QMS)

An appropriate infrastructure (e.g. ISO 9000) encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality.  WHO TRS 937 Annex 5

Qualification Report

A formally written or electronically produced record detailing a qualification study.

Quality Risk Management

Is a key part of Quality System Framework.  It is the systematic process for the assessment, control, communication and review of risks to the quality of the medicinal products across the product lifecycle.  All Life Sciences & Healthcare sites must have a QRM procedure in accordance with Healthcare Quality Guideline No. 23.  Source: EU GMP Annex 20, ICH Q9, ICH q10 1.6.2, ISO 14971:2007, GHTF SG3

Qualification

A documented testing that demonstrates with a high degree of assurance  that a specific process will meet its pre-determined acceptance criteria.  PDA Pharmaceutical Cold Chain Discussion Group  

Quarantine

The status of pharmaceutical products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing.  WHO TRS 937 Annex 5

Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. WHO TRS 937 Annex 5

Reagent

Is a substance or compound that is added to a system in order to bring about a chemical reaction or is added to see if a reaction occurs.

Refrigerant

A refrigerant is a substance used in a heat cycle usually including, for enhanced efficiency, a reversible phase change from a gas to a liquid. Traditionally, fluorocarbons, especially chlorofluorocarbons were used as refrigerants, but they are being phased out because of their ozone depletion effects. Other common refrigerants used in various applications are ammonia, sulfur dioxide, and non-halogenated hydrocarbons such as methane.

Refrigerated Containers

See Active Packaging.  

Regulatory Audit

Prior to being issued with a license the authorities will have an inspector undertake an audit to ensure that the facility is competent to manage pharmaceutical storage and distribution in compliance with the regulations.  Inspections will normally occur once every 1-3 years by prior notification from the inspectorate based on complexity and risk.Source: GHTF SG4, RSA MCC GMP

Regulatory Affairs

This function ensures the company is compliant with its GxP requirements by ensuring the integrity of the information flow is maintained between the customers and regulatory authorities.

Regulatory Compliant Standard Operating Procedure

Is a written document / instruction that is approved by all parties along the supply chain which details all steps and activities of a process or procedure specific to ensuring compliance with all global regulations for pharmaceutical storage and distribution. Procedures should describe the different operations which may affect the quality of the products or of the distribution activity (e.g. receipt and checking of deliveries, storage, cleaning and maintenance of the premises, recording of the storage conditions, security of stock on site and consignment in transit, returned products, etc.)  The procedure should be carried out without any deviation or modification to guarantee the expected outcome. Any modification or deviation is thoroughly investigated and outcomes of the investigation documented according to the LifeConEx Investigation Procedure Process.  Source:  WHO TRS 937 Annex 5, Sections 5,6,9,11,12 &14.  EU GMP Part 1 4.19-4.26.  EU GDP (94/C 63/03) 6. ISO 13485:2003.4.2.1b/d  

Reproducibility

The repeatability of a measurement

RFI

Request for Information

RFP

Request for Proposal

RFQ

Request for Quotation

Robust

The ability of a container system to maintain its required internal minimum and maximum temperature under varying ambient conditions. Also called thermally robust.

Room Temperature

Typically refers to 22°C or 72°F.

R-Value

A measure of thermal resistance of an insulated material. A higher R-value indicates greater insulative properties.

RX-360

Is a consortium being developed by volunteers from the Pharmaceutical and Biotech industry which includes their suppliers.  The purpose is to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain.

Saddlebag

A type of gel pak that surrounds the product to provide a temperature-stabilizing environment.

Secondary Packaging

The packaging into which the primary packaging is placed.  WHO TRS 937 Annex 5

Seasonal Packout

Shipping systems whose packouts will differ over the seasons (e.g., winter packout, summer packout).

SFDA

State Food and Drug Administration - is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.

Shelf-Life

The period of time during which a pharmaceutical product, if stored correctly, is expected to comply with the specification as determined by stability studies on a number of batches of the product.  The shelf-life is used to establish the expiry date of each batch.  

Shipper (linked to Shipper and Shippers)

The entity that prepares goods for shipment, by packaging, labeling, and arranging for transit, or who coordinates the transport of goods.

Shipping

The process of transporting a package from one location to another.

Shipping System

The insulated shipping container and its internal thermal packaging components (refrigerants, buffering materials, dunnage, etc.).

Single-blind Trial

A clinical trial in which the investigator is aware of the treatment for each patient, but the patient is not. In this type of trial, there is no placebo effect based on the patient's knowledge of treatment (new or another). Bias is possible, however, since the investigator may treat the patient differently, possibly even hinting treatment-related details.

Single Wall Corrugated Board

A structure formed when one corrugated inner member is glued between two flat facings.

SKU

Stock Keeping Units - A numerical system used to track inventory of a specific product.

SOP

Standard Operating Procedure - Is a written document / instruction detailing all steps and activities of a process or procedure. The procedure should be carried out without any deviation or modification to guarantee the expected outcome. Any modification or deviation should be thoroughly investigated and outcomes of the investigation documented according the internal deviation procedure. This is an area for which it is common for non-compliance issues to be identified.  SOP's and instructions must be adhered to.  Control of procedures I very important and it should be understood that amendment is possible but only in an approved manner.  Source:  EU GDP (94/C  63/03) 6.  WHO TRS 937 Annex 5, 12.2.  ISO 13485:2003 4.2.1c.  

SOP Grading System

The LifeConEx Standard operating grading system designed for a deeper post-shipment data analysis of each process which assigns a grade to each trade lane within a cold chain network.  Grading is based upon the LifeConEx LifeControl Quality Management System

SPE

Society for Pharmaceutical Engineering

Stability

Refers to the ability of a product to remain efficacious under varying temperature/time exposures.

Storage

A term used to describe the safe keeping of materials and products such as starting materials and finished products received from suppliers, or semi-finished products  in process and finished products awaiting dispatch and products awaiting distribution to retailers and products (rejected, recalled and damaged) awaiting disposal.  Source:  Guidelines for Good Distribution Practice

Storage Temperature

The temperature at which a product is stored.

Supplier

A person providing products or materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders.  Source:  Guidelines for Good Distribution Practice

Supply Chain

Is a system of organizations, people, technology, activities, information and resources involved in moving a product or service from supplier to customer.

Technical Report No. 39

The Parenteral Drug Association's revised edition of Technical Report No. 39, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment.This Technical Report originally issued in 2005, provides guidance to the biopharmaceutical/pharmaceutical industry and regulators on the essential principles and practices for shipment of products which require controlled temperature during transit. It also provides a design approach to the development of specialized packages and systems which will protect temperature-sensitive products during transportation.

Temperature Control

Is a process in which change of temperature of a space (and objects collectively there within) is measured or otherwise detected, and the passage of heat energy into or out of the space is adjusted to achieve a desired average temperature.

Temperature Cycle

See External Temperature Cycle.

Temperature Probe

A device that measures the temperature of a specified environment.

Temperature-Sensitive Product

A product for which stability is impacted by temperatures outside a prescribed range (e.g., vaccine).

Thermal Mapping

Defining the temperatures witnessed throughout many points in the container over time. Thermal mapping of the environment refers to collection of the data necessary to model the ambient temperatures witnessed by a shipment as it moves throughout the distribution process.

Thermal Solutions

Package designs that meet the thermal requirements of a temperature-sensitive product.

Thermocouple

A device with a pair of wires of dissimilar metals (e.g., copper and iron) that accurately measures temperature.

Thermodynamics

The branch of physics that deals with the conversions from one to another of various forms of energy and how these affect temperature, pressure, volume, mechanical action, and work.

Tolerance

The acceptable range for a specified measurement.

Trade Lane

A term used to indicate the general flow of shipping between two departure/terminal areas.  In the logistics environment, this is the shipper sending the goods and the consignee receiving those goods.

Temperature Packaging Solution

An efficient packaging system designed to control the temperature during shipping of a payload per specific requirements (also called a refrigerated shipping container, refrigerated packaging).

Transit

The period during which pharmaceutical products are in the process of being carried, conveyed, or transported across, over or through a passage or route to reach the destination.  WHO TRS 937 Annex 5

Transit Duration

The amount of time that a shipment remains in transit.

Triple-blind Trial

Triple-blind trials are double-blind trials in which the statistician interpreting the results also does not know which intervention has been given. Sometimes triple-blind is used to mean that multiple investigators are all blinded to the protocol (such as the clinician giving the treatment and a radiologist or pathologist who interprets the results). The use of the term triple-blind experiments is disputed.

UNICEF

United Nations Children's Fund - an agency of the United Nations responsible for programs to aid education and the health of children and mothers in developing countries.

Universal Packout

A shipping system whose packout and conditioning of components are the same year round.

USDA

United States Department of Agriculture - is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food.

USP

U.S. Pharmacopoeia - is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States.

USP 797

Is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.

USP 1079

Provides manufacturers, distributors, and transporters with assistance in handling pharmaceutical items. The document includes information on storage and shipping practices to ensure the integrity of the product from manufacturer to end user.

Vaccine

A biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins. The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters.

Vaccine Trial

A clinical trial to study the efficacy of a vaccine.

Validation

Action of proving and documenting that any process, procedure, or method actually and consistently leads to the expected results.  Source:  FDA Guidelines on General Principles of Process Validation

Vehicle

Refers to trucks, vans, buses, mini-buses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.WHO TRS 937 Annex 5

VIP

Vacuum Insulated Panels offer high R-value insulation.

Warm

Any temperature between 30° C; and 40° C; (86° and 104° F).(Source: USP 797)

Warning Letter

A warning letter is issued by the FDA when upon inspection a manufacturer has significantly violated FDA regulations. The letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plan for correction. WHO TRS 937 Annex 5

WFI

Water for Injection

WHO

World Health Organization - WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

Wholesaler

Any person who is engaged in wholesale distribution of prescription drugs, CHC drugs, generics, including but not limited to, manufacturers, re-packers, own-label distributors, private-label distributors, jobbers, brokers, warehouses – including those manufacturers, distributors, and pharmacists who conduct wholesale distribution.  WHO TRS 937 Annex 5

Working SOP

Is a controlled document that is designed for the LifeConEx Life Science Service Center professional to quickly understand exactly what actions are to be performed within the process mapping module of the LifeConEx LifeTrack IT system.  This SOP is and expedited process that is not approved by all supply chain partners and is not regulatory compliant.  

XPS

Extruded Polystyrene - is an aromatic polymer made from the monomer styrene, a liquid hydrocarbon that is manufactured from petroleum by the chemical industry. Polystyrene is one of the most widely used plastics, the scale being several billion kilograms per year.

X Service (Expedited)

When you need to ship in less than 3 business days and process mapping is adequate for your urgent solution, LifeConEx X Service is your solution. Our quality team offers an incident report upon request.