E-DRUG: Is the pharma industry moving forward for global marketing?
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Dear E-druggers,
The standardization of pallets and shipping containers has revolutionized the global market. These items are ubiquitous in all the nations of the world and that standardization has reduced costs and time frames for moving goods.
What about the pharmaceutical industry? A quick review of the WHO Technical Report Series No.953, 2009; Annex 2, Appendix 1, Table 2: Confirmed Long-Term Stability Testing Conditions shows that there are large numbers of countries with 25 degrees C and also others with 30 degrees C. Fortunately a product meeting the 30 degrees C testing protocol will also meet the 25 degrees C requirement. Thus for a global product one label for 30 degrees C storage will meet the requirements for the global market.
An additional marketing problem is the expiry period. New products generally come on to the market with a 24 month expiry period. Since many importing countries require75-80% of the expiry period available to minimize expiration losses in their supply chains only 5-6 months are available for the supply chain dwell-time from manufacture through importation. This is a very stringent requirement for shipping, warehousing and distribution. Fortunately most firms continue the shelf-life stability studies to obtain 36 and 48 month expiry periods; the 48 month period allows a much more realistic and comfortable 10-12 months for the transit dwell-time from production through importation and makes the global market more accessible.
For a global product the pharmaceutical industry should perform long-term stability testing at 30 degrees C and should push the shelf-life expiry period to the 48 month mark as is practicable.
regards
Tom Layloff
Senior Quality Assurance Advisor
Supply Chain Management System
Arlington, VA,USA
tlayloff@pfscm.org