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This years TRAX Conference Pharmaceutical Supply Chain Integrity, August 7-9, 2006 at the Ritz Carlton Tyson's Corner in McLean,VA produced two clear and significant themes - the tone of which can be summed up in the opening remarks from Leonardo DeCandia, Senior Vice President, Supply Chain Management for AmerisourceBergen Corporation.

"If you are not 100% committed to responsibly provide the delivery of drugs and therapies to the patients who need them, then get out of my industry."

The event began with a one-day symposium on cold-chain: delivering new guidelines on the proper handling of temperature sensitive goods, an interactive session that featured presentations on USP Guidelines, the evolving distribution model for temperature sensitive products, understanding bottom line costs in thermal packaging and case studies on methods for qualifying refrigerated trucks.

Among the messages gleaned from the conference by my colleagues and other delegates are:

- Changes in "cold chain" guidelines and regulations are eminent and are predicted to have a significant impact on the supply matrix of pharmaceutical wholesalers and distributors.

- Pharmaceutical manufacturers are expanding their acceptance of responsibility and accountability of their products through the supply chain. They are tightening their "terms of sale" to include thermal packaging compliance in an effort to mitigate their liability and exposure to a changing environment.

- Pharmaceutical manufacturers scope of concern is forcing them to "re-qualify" their distribution partner’s logistics practices, establishing exclusive sourcing agreements for sustained business or potentially "interrupted/discontinued" representation for non-compliance.

- Some distributors continue to openly admit that they are "guessing" at their cold chain packaging practices. That they "do not know how to pack out" or "validate" their packaging and that audits by drug manufacturers note this as a serious and significant deficiency.

- One pharmaceutical company (name removed) has undergone two separate FDA audits this year specifically targeting temperature sensitive distribution practices. No 483's were issued. However, recommendations were made by the agency requiring a corrective action response. The document the agency used as reference to identify the deficiencies was <USP 1079>.

The Singapore Health Science Authority, Manufacturing & Quality Audit Division, Center For Drug Administration has released Guidance Notes on Good Distribution Practices, which includes sections on temperature sensitive materials. There is also a section on general points to consider for auditors and auditees. Click on the link to view a .pdf  version of the document in its entirety. (Also found under the Bibliography tab to the left).

The Pharmaceutical Cold-Chain Discussion Group, (PCCDG) an active working group of the PDA and the leading pharmaceutical industry organization advocating good distribution practices for temperature sensitive medicinal products, announced that it will undergo a name change to the Temperature Control Pharmaceuticals Group (TPG).

The name change comes as the result of incorporating the European counterparts to the PCCDG, the Cold-Chain Committee (C3) and the Pharma Logistics Forum (PLF). They will all now function as one group, with a common objective, under the auspices of the PDA. The change was agreed upon in a meeting held July 13th, 2006, by representative members of the three groups who comprise the steering committee of the organization. Dr. Rafik Bishara, chair of the PCCDG, will continue to preside as chairman of the TPG.

Their Mission Statement is as succinct as their new moniker: "Define and promote good practices in the storage and transport of pharmaceutical materials"

Their first objective is to amend Technical Report #39 so that it is agreeable and applicable to both US and European objectives.

Also during the teleconference meeting, Dr. Bishara confirmed that the 1st PDA European Cold Chain Conference will take place in Berlin, Germany, on October 5th and 6th, 2006. He has agreed to chair the organizing committee and Shirley-Ann Feld, Janne Grusgaard and Hugo Wegewijs (C3 and J&J) have agreed to work with Rafik on organizing the event.

Rafik strongly encouraged global members to participate in the conference and is working diligently to invite others from various countries to present and participate. Also, cold-chain service providers will most likely participate. Further details can be found at the PDA web site under the 'programs & meetings section.