1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products, Q1a (R2), 6 February 2003, www.ich.org.
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7, 10 November 2000, www.ich.org.
3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Pharmaceutical Development, Q8 (R2), August 2009, www. ich.org.
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Quality Risk Management, Q9 Step 4, 9 November 2005, www.ich.org.
5. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Q10, Pharmaceutical Quality System, Step 4, 4 June 2008, www.ich.org. 6. World Health Organization: WHO Expert Committee on Specifications for Pharmaceutical Preparations – Fortieth Report 2006, www.who.int. • E1: Equipment Performance Specifications for Cold Rooms and Freezer Rooms • E3: Equipment Performance Specifications for Refrigerators and Freezers • E4 and E11: Equipment Performance Specifications for Insulated Containers • E5: Equipment Performance Specifications for Ice Packs • E6: Equipment Performance Specifications for Temperature-Monitoring Devices • E7: Equipment Performance Specifications for Cold Chain Accessories
7. US Code of Federal Regulations, Title 21, Food and Drugs, www.fda.gov. • 21 CFR Part 11 – Electronic Records, Electronic Signatures
8. US Pharmacopeia, USP General Chapter Requirements, www.usp.org. • USP 34-NF 29 (this is official on 1 May 2011)
9. European Medicines Agency (EMA), www.ema.europa.eu.
• EU GMP Annex 11 to the EU Guide to Good Manufacturing Practice • EU GMP Annex 15 to the EU Guide to Good Manufacturing Practice
• EECEU 94/C 63/03: Guidelines on Good Distribution Practice of Medicinal Products for Human Use 10. Therapeutic Goods Administration (TGA): Australian Code of Good Wholesaling Practice for Therapeutic Goods
for Human Use, www.tga.gov.au.
11. The Australian Standard AS 2853-1986: Enclosures – Temperature Controlled – Performance Testing and Grading.
12. French Standard (NF X15-140 October 2002 Measurement of Air Moisture – Climatic and Thermostatic Chambers – Characterization and Verification).
13. German Standard DIN 12880 Electrical Laboratory Devices – Heating Ovens and Incubators. 14. International Safe Transit Association (ISTA), www.ista.org.
• ISTA Resource Book 2009 • Procedure 5B • Procedure 7D • Procedure 7E • Standard 20 Global Standard for Establishing Performance of Insulated Shipping Containers 15. EPC Global Standard, www.gs1.org/epcglobal.
16. International Electrotechnical Commission (IEC), www.iec.ch • IEC Publication 584, Thermocouples
• IEC Publication 751, Resistance Temperature Detectors
17. Good Distribution Practice: Guidance and Legislation, Medicines and Healthcare products Regulatory Agency (MHRA), www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodDistributionPractice/ Guidanceandlegislation/index.htm
18. ANSI/ASHRAE Standard 34 “Designation and Safety Classifications of Refrigerants,” www.ansi.org. 19. ASTM International, www.astm.org.
• ASTM D4169-08 Standard Practice for Performance Testing of Shipping Containers and Systems • ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment • ASTM E2537 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing 20. ATP “Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment” to be used for such carriage, www.unece.org/trans/main/wp11/atp.html. 21. CPMP/QWP/609/96/Rev 2 Guideline on Declaration of Storage Conditions A – In the product information of medicinal products B – for active substances, www.ema.europa.eu. 22. Guidelines for Temperature Control of Drug Products during Storage and Transportation, GUI-0069, Health Canada / Health Products and Food Branch Inspectorate, 28 April 2011, www.hc-sc.gc.ca. 23. IMB Draft: Guidance Note on Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products, Irish Medicines Board (IMB), www.imb.ie.
24. ISPE Baseline® Pharmaceutical Engineering Guide Series, International Society for Pharmaceutical Engineering
(ISPE), www.ispe.org.
• Volume 5 – Commissioning and Qualification, First Edition, March 2001
25. ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, International Society for Pharmaceutical Engineering (ISPE), under development at time of publication, www.ispe.org.
26. ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Operations (PACLAW), International Society for Pharmaceutical Engineering (ISPE), under development at time of publication, www.ispe.org.
27. ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment, International Society for Pharmaceutical Engineering (ISPE), under development at time of publication, www. ispe.org.
28. ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems, International Society for
Pharmaceutical Engineering (ISPE), Fifth Edition, February 2008, www.ispe.org.
29. ISPE GAMP® Good Practice Guides, International Society for Pharmaceutical Engineering (ISPE), www.ispe.org.
• Risk-Based Approach to Compliant Electronic Records and Signatures, First Edition, February 2005. • A Risk-Based Approach to Calibration Management, Second Edition, November 2010.
30. National Oceanic and Atmospheric Administration’s (NOAA) National Weather Service, www.noaa.gov. 31. PIC/S GMP Guide PE 009-9 (Part I: Basic Requirements for Medicinal Products) 1 September 2009, www.
picscheme.org.
32. PDA Technical Reports, www.pda.org.
• Technical Report 39 (TR39), Guidance for Temperature Controlled Medicinal Products • GDP Good Distribution Practices • Cold Storage Warehouses/Walk-In Cold Rooms • Temperature Controlled Trucks/Trailers • Temperature Controlled Transport Containers (Pallet Size and Smaller) • Temperature Control Training for Active Systems • Guidance for the TSA Cargo Screening • Stability Testing to Support Distribution of New Drug Products • Active Systems: Temperature Controlled Sea Containers • Pharma Standard for Re-Usable Passive Shipping Systems • Risk Management for Temperature Controlled Distribution 33. World Health Organization (WHO) Guidelines, www.who.int.
• WH 460 – Manual on the Management, Maintenance, and Use of Blood Cold Chain Equipment • WHO/V&B/01.05 – Guidelines on the International Packaging and Shipping of Vaccines • WHO Technical Report Series, No. 957, 2010. Annex 5 – WHO Good Distribution Practices for Pharmaceutical Products • WHO/BS/10.2129 – Model Guidance for the Storage and Transport of Time and Temperature–Sensitive Pharmaceutical Products 34. GS1 Global Traceability Standard in Healthcare (GTSH), www.gs1.org/docs/gsmp/traceability/Global_ Traceability_Standard_Healthcare.pdf.