Documents from regulatory agencies and from guidance bodies are included in this section.
"Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use"  |
| 04-30-1992 , European Union |
| This is a European Union document addressing the wholesale distribution of medicinal products for human use. |
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| Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) |
| 05-23-2001 , European Union |
| This is a European Union document addressing the distribution of medicinal products for human use. |
| Document : gdpguidelines1.pdf |
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| "Packing Protocols for Temperature Sensitive Medical Products requiring Storage and Transportation Temperatures between 2ºC - 8ºC (36ºF - 46ºF)" |
| 06-11-2002 , U.S. Army Medical Materiel Agency (USAMMA)/Distribution Operations Center (DOC) |
| This document from the U.S. Army Medical Materiel Agency (USAMMA)/Distribution Operations Center (DOC), which is available online, provides the packing instructions to be followed by this agency for refrigerated medical products. |
| Document : pkprotocols.pdf |
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| WHO: "Guide to good storage practices for pharmaceuticals" |
| 08-28-2002 , World Health Organization (WHO) |
| This guide, authored by WHO Expert Committe on Specifications for Pharmaceutical Preparations, is intended for those involved in the storage, transportation and distribution of pharmaceuticals. |
| Document : s6156e.pdf |
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| WHO Expert Committee on Specifications for Pharmaceutical Preparations |
| 04-03-2003 , Word Health Organization |
| This guidance document from the World Health Organization discusses special measures considered appropriate for the storage and transportation of pharmaceuticals, applicable to pharmaceutical manufacturers, pharmaceutical importers, contractors and wholesalers, community and hospital pharmacies. |
| Document : WHO_TRS_908.pdf |
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| "Guidance for Industry; Part 11, Electronic Records; Electronic Signatures — and Application" |
| 08-01-2003 , FDA |
| This guidance is intended to describe the Food and Drug Administration's (FDA’s) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). This guidance may impact the type of electronic/digital monitoring hardware and software used for continous monitoring of pharmaceutical products in transit, for qualification of shipment methods, as well as monitoring of storage locations. |
| Document : FDA CFR Part 11 guidance 2003.pdf |
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| "Inspections of Licensed Biological Therapeutic Drug Products" |
| 10-17-2003 , FDA |
| This is chapter 56 of the FDA's Compliance Program Guidance Manual (Program 7356.002M) which discusses Inspections of Licensed Biological Therapeutic Drug Products.
Within this document, section 3.C (page 10 of 30) discusses validation of shipping conditions, containers and methods.
Section 10.D (page 21 of 30) also mentions shipping temperatures in the context of stability. |
| Document : FDA Inspection of biologics 2003.pdf |
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| "Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products" |
| 11-07-2003 , Medicines and Healthcare Products Regulatory Agency (MHRA) |
| This document from the Medicines and Healthcare Products Regulatory Agency (MHRA), discusses Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products. This article was written by John Taylor, CChem, FRSC. |
| Document : CON007569.pdf |
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| C3: "Guidance for Shippers and Transport Service Providers" |
| 08-06-2004 , Cold Chain Committee (C3) |
| This document, authored by the C3, provides guidance for shippers, transport service providers and sub-contractors involved in the distribution of pharmaceutical products registered for storage between 2° and 8° Celsius. |
| Document : GuidanceforshipperAUG2004.pdf |
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| C3: "Guidance for Insulated Shipping Containers" |
| 08-06-2004 , Cold Chain Committee (C3) |
| This document, authored by the C3, provides guidance for the development of insulated shipping containers to ensure the quality of products, which have registered storage conditions between 2° and 8° Celsius. |
| Document : GuidanceforInsulatedShippingContainersAUG2004.pdf |
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| Guidance for FDA Staff and Industry: "RFID Feasibility Studies and Pilot Programs for Drugs" |
| 11-01-2004 , Food and Drug Administration (FDA) |
| The goal of this Compliance Policy Guide (CPG) is to facilitate the performance of RFID studies and allow industry to gain experience with the use of RFID. |
| Document : FDA RFID Guide SEC 400-210.pdf |
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| WHO: "Study Protocol for Temperature Monitoring in the Vaccine Cold Chain" |
| 01-01-2005 , World Health Organization |
| This document is a study of the cold chain as it relates specifically to vaccines, with the objective of providing a protocol for documenting the level of freezing in the cold chain, and identifying specific problem areas where corrective actions may be required. |
| Document : WHO_IVB_05.01.pdf |
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| Brazil Good Distribution Practices of Pharmaceutical Products |
| 04-11-2005 , Mercosur |
| This article, in spanish language, discusses Brazil's Good Distribution Practices of Pharmaceutical Products. The document is Mercosur GMC RES No. 49/02, LXVIII GMC - Brasilia, 28/XI/02. |
| Document : Brasil.pdf |
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| Health Canada: "Guidelines for Temperature Control of Drug Products during Storage and Transportation" |
| 10-17-2005 , Health Canada |
| This document, Guide-0069, discusses Health Canada's guidelines for Temperature Control of Drug Products during Storage and Transportation. |
| Document : Health Canada Cold Chain.pdf |
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| Australian Government: "National Vaccine Storage Guidelines" |
| 11-22-2005 , Australian Government |
| This document is aimed at Australian vaccination service providers as a concise, practical user guide to vaccine storage. This document replaces "Keep it Cool" (2nd edition, 2001). |
| Document : strive-4-five.pdf |
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| Stability Testing of New Drug Substances and Products Q1A (R2) |
| 02-28-2006 , International Conference on Harmonization |
| This document from ICH (International Conference on Harmonization), for technical requirements for registration of pharmaceuticals for human use, provides stability testing guidelines, relative to established climatic zones. A definition for Mean Kinetic Temperature is provided, as well as verbiage on storage condition tolerances. |
| Document : ICH Q1A R2.pdf |
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| Irish Medicines Board: "Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances" |
| 03-28-2006 , Irish Medicines Board |
| The purpose of this document is to provide guidance to medicinal product manufacturers (Human and Veterinary), wholesalers and transporters of human medicinal products in Ireland and manufacturer’s of Active Pharmaceutical Ingredients (APIs) in relation to conditions for cold storage / cold chain and controlled temperature storage.
This guide does not purport to be an interpretation of the law and/or regulations relating to cold chain temperature and is for guidance purposes only. |
| Document : Guide for trans of med 194333_IND_003_01.pdf |
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| PDA Technical Report 39, Revised 2007 (TR39) |
| 01-01-2007 , PDA (Parenteral Drug Association) |
| This revised report is one of the key documents providing guidance to the pharmaceutical industry on cold chain qualification. |
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| USP General Chapter <1079> Good Shipping and Storage Practices |
| 01-01-2007 , USP (United States Pharmacopeia) |
| This document from the United States Pharmacopeia (USP) is another key document providing guidance to the pharmaceutical industry on cold chain qualification. |
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| IATA Perishable Cargo Regulations (PCR) Manual |
| 01-01-2007 , IATA |
| "IATA’s Perishable Cargo Regulations (PCR) manual has become the world standard for the preparation, packaging and handling of time- and temperature-sensitive goods. Applying to all IATA member airlines, the PCR is the new leader in Cold Chain Management for pharmaceutical products and non-hazardous biological material. Not only will it provide you with the most efficient practices for your shipping of perishable cargo throughout the entire supply chain, but it will also answer all your questions regarding urgent time- and temperature-sensitive shipping". IATA |
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| WHO: "Good Distribution Practices For Pharmaceutical Products Including Measures Against Penetration Of Counterfeits Into The Legitimate Supply Chain" |
| 09-17-2008 , World Health Organization |
| Following the adoption of the WHO guideline for good distribution practices (GDP) by the Fortieth WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2005 this guideline has been revised by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) partnership. |
| Document : GDP_counterfeits_QAS08_252_11012008.pdf |
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| PDA Technical Report 46, January 2010 (TR46) |
| 01-01-2010 , PDA (Parenteral Drug Association) |
| This Technical Report from the PDA, titled "Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User", focuses on providing guidance "on the proper handling of controlled-temperature medicinal products and devices along the final legs of the distribution chain". |
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