IPQ Monthly Update — July/August 2011 in Review

The problems that have been surfacing with glass vials and syringes – and what firms and regulators are doing to understand them better and improve control practices – are spotlighted in IPQ’s July/August Monthly Update (the once-a-month publication cycle resumes in September).

The complex issues that glass control presents for injectable products were explored at a two-day conference cosponsored by PDA and FDA and a one-day follow-up symposium organized by the supply chain consortium Rx-360 in late May.  The Monthly Update includes a series of six stories stemming from the probing presentations and industry/regulator dialogue at the meetings. Taken together, the series provides an in-depth look at this front-burner topic and its significance.

The stories focus on:

● the recent spate of glass lamellae-related recalls and FDA’s perspective on the issues involved

● a survey of where drug and biologic manufacturers are in their glass control practices

● the harder look industry is taking at plastic injectable containers

● USP’s effort to revise and expand its compendial standards and guidance to help address the challenges

● the learnings from Amgen’s deep dive into the causes of and cures for glass delamination in the wake of its Epogen recall, and

● how the PDA/FDA and Rx-360 forums advanced the understanding of the challenges and the need for cooperation between glass suppliers and pharmaceutical users to meet them.

Also covered on the US front is a revealing report by J&J’s board on the causes of McNeil’s GMP problems, which provides a cautionary tale about how acquisitions, staffing and communication issues can impact a big pharma firm’s compliance status.

The EU has made a substantial contribution to the product manufacturer-to-patient component of the global GDP effort in its new GDP draft guideline – out for public comment through the end of the year.  The IPQ story in this issue explores the context and significance of the draft guideline and the new territory it covers.

Internationally, with the help of insights provided by an expert from J&J, the Monthly Update addresses the divergences among the countries in Latin America in their expectations for the form and content of CMC submissions and the efforts underway to achieve more harmonization in the region.

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