IPQ Monthly Update — October 2011 in Review

The regulatory process for manufacturing changes and how that process can be improved to better coalesce with the Q8-10 paradigm remains a front-burner issue for the international pharmaceutical community.

In the October Update, IPQ focuses on the discussion at an October ICH Q10 conference around the dichotomy between the continuous improvement objectives of the new paradigm and the roadblocks presented by the disharmony in change filing requirements across the globe.  A second story focuses on the European Commission’s effort to further rationalize and harmonize the handling of variation filings across Europe.

Another pair of stories in the October Update explores how international pharma is relating to its supply chain and how that relationship can be improved.

IPQ focuses on a thought-provoking analysis by a recognized supply chain pundit of pharma’s current outsourcing and purchasing strategies and the hidden financial, quality and regulatory pressures that could force the industry to reevaluate them.  Also provided is a hard look at the supplier/big pharma relationship from the supplier’s vantage point – bringing into relief the disconnects between pharma’s QbD objectives and its purchasing negotiation modus operandi.

On the FDA front, the October Update includes an inside view provided by two field managers at how decisions are made regarding: ● the significance of the 483 observations their investigators are reporting, and ● the acceptability of NDA/ANDA filings in moving forward with preapproval inspections and how deficient cover letters are creating delays.

Also in focus on the FDA compliance front is a new guidance on PET drug process media fills and an intriguing PET generator recall stemming from passengers showing up positive on radiation scans at airports.

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