Global Efforts in Cold Chain Management and Good Transportation Practice Increase

GMP News No. 884: Global Efforts in Cold Chain Management and Good Transportation Practice Increase

GMP News
7 February 2007
 

Global Efforts in Cold Chain Management
and Good Transportation Practice Increase

 
The FDA has been evaluating what steps the agency can take to ensure that temperature conditions do not compromise pharmaceuticals while being stored or distributed. Nicholas Buhay discussed the agency initiative at a Cold Chain Conference in 2006 (see 'The Gold Sheet' September 2006). Because of the attention industry is applying to the cold chain and distribution issues, "the risk level right now is not at the point where a deliberate programmatic effort of inspection, of sample collection or of case development is needed", Buhay commented.

At the same conference, MHRA Quality and Standards Manager Acting and Group Manager John Taylor noted that medicines should get controlled temperature if needed. John Taylor, who is a member of the ECA Advisory Board, has presented his views also at a recent ECA Conference. More than 30% of deficiencies of inspected distribution activities were linked to temperature control and monitoring and cold chain transportation. Although in Europe (and especially in the U.K.) requirements are in place, industry still needs to put more efforts in temperature control.

Health Canada came along with Guidelines for Temperature Control of Drug Products during Storage and Transportation. The guidance was developed to be consistent with existing documents from WHO, EU, USP and ICH.

In August 2006, the World Health Organization (WHO) has released in hard copy the Guidelines on the International packaging and shipping of vaccines (2005) which are available in electronic form under the following link: http://www.who.int/vaccines-documents/DocsPDF06/818.pdf. Especially vaccines are products where temperature deviations could result in an ineffective product. This 2005 edition takes into account new developments in the field of vaccine stability and temperature monitoring. A special section has been added to describe the temperature limits for international shipments.

In another initiative, the WHO and more than 20 international partners launched a comprehensive package of measures in November 2006 to help national authorities safeguard their populations from the dangers of counterfeit medicines: IMPACT (the International Medical Products Anti-Counterfeiting Taskforce).
  

Hear John Taylor from MHRA and Dr Ümit Kartoğlu from WHO speak at the ECA Conference Good Distribution Practice and Cold Chain Management in Vienna, Austria from 19–20 June 2007. Also, specialists from the pharmaceutical industry and service providers will share their expert knowledge about all relevant aspects regarding the current expectations and the actual development in Good Distribution Practice and Cold Chain Management.

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
  

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