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Cold Chain Compliance.
April 16, 2014
Good Day

Cold chain Importance.

Cold Chain Validation suddenly became a hot topic when the results of a government investigation into Cold Chain distribution compliance were published.
The facts release indicated that nearly a quarter (23%) of all drugs distributed in the USA, are of unknown efficacy. The distribution of these temperature sensitive products in vehicle containers that lacked validated methods of maintaining the correct internal temperature or even the ability to produce a validated history of what the actual conditions were; has rendered these products 'adultered', i.e. of unknown efficacy or safety. Vehicle body internal temperatures; with seasonal variations, can range from a high of 50 to a low of -40 (degrees centigrade). In contrast the mandated internal temperature for distribution containers for standard drugs and medical products is 2 to 8 (degrees centigrade), with much lower temperatures specified for some drugs.

This shocking news has certainly guaranteed that Cold Chain Validation compliance will be top of everyone's audit list, specifically when drug interactions with the end user are considered as critical. The implications of products being damaged and out of specification may induce many companies to replace doubtful goods or even trigger the regulators into initiating product recalls. This problem is expected to create a veritable stampede as distributors scramble to ensure that all the vehicles and containers they used in this essential everyday service, are rendered Cold Chain compliant, as soon as is possible.

Comments that are now in every day use throughout the industry:-

Any vaccine that has not been stored at a temperature of 2-8ºC as per its licensing conditions is no longer a licensed product.

Where there is any doubt that cold chain has not been maintained, medications should not be used.

Cold Chain Temperature Fluctionations.(/b)

 According to a recent study conducted by the U.K. based Medicines and Healthcare Products Regulatory Agency (MHRA), a staggering 43% of critical and major product deficiencies are related to ineffective temperature control and monitoring during storage and transportation.

Similarly the World Health Organization (WHO) recently maintained that 25% of all vaccine products arrive at their final destination in a degraded state. Given the high cost of conducting global clinical trials and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain - transportation and logistics providers included − conform to GxP guidelines and immediately activate procedures to attain Cold Chain Validation compliance.

  1. WHO’s “Good distribution practices for pharmaceutical products” and “Guide to good storage practices for pharmaceuticals”
  1. FDA’s “cGMP / 21 CFR 211”
  1. U.S. Pharmacopeia (USP) <1079> “Good Storage and Shipping Practices”
  1. Canada’s “Guidelines for Temperature Control of Drug Products during Storage and Transportation”
  1. Ireland’s “Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances”
  1. EU’s “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” (94/C 63/03)

It is anticipated that these finding will move all things to do with - product quality in transit - to the top of visiting regulators inspection lists. The obvious priority being the thermal validation of transit containers - be they demountable or integral to a motor vehicle.

Validation of these containers and or vehicles is not difficult and can be tackled (using our fully detailed documents) by most technicians and or laboratory assistants.

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