Temperature mapping of storage areas Technical supplement to who technical Report Series, No. 961, 2011
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Bibliography
■ Health Canada (Health Products and Food Branch Inspectorate). Guide 0069, Guidelines for temperature control of drug products during storage and transportation. Ottawa: Health Canada; 2005 (http://www.rxcritical.ca/pdf/Guide-0069.pdf ) ■ International Air Transport Association (IATA). 2013/2014 Perishable cargo regulations (ePCR) and temperature control regulations (eTCR). Geneva: IATA (http://www.iata.org/publications/Pages/temperature-control-regulations.aspx, accessed 10 February 2015). ■ Parenteral Drug Association. Technical Report No. 39: Guidance for temperature controlled medicinal products: Maintaining the quality of temperature-sensitive medicinal products through the transportation environment. Bethesda (MD): Parenteral Drug Association; 2007 (https://store.pda.org/ProductCatalog/Product.aspx?ID=1270, accessed 10 February 2015). ■ United States Pharmacopeia (USP): Chapter 1079: Good storage and shipping practices. Rockville (MD): USP (https://mc.usp.org/sites/default/files/documents/GeneralChapterPDFs/ c1079%20USP36.pdf, accessed 10 February 2015). ■ United States Pharmacopeia: Chapter 1118: Monitoring devices – time, temperature and humidity (http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1118.html, accessed 10 February 2015). ■ US Food and Drug Administration (US FDA). Title 21--food and drugs. Chapter I--Food and Drug administration Department of Health and Human Services. Subchapter A--general. Part 11 electronic records; electronic signatures 21 CFR Part 11. Silver Spring (MD): US FDA (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch. cfm?cfrpart=11, accessed 10 February 2015). ■ World Health Organization. Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical pharmaceuticals. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty- fifth report. Geneva: World Health Organization; 2011: Annex 9 (WHO Technical Report Series, No. 961; http://apps.who.int/medicinedocs/ documents/s18683en/s18683en.pdf, accessed 10 February 2015). |
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