Among the important regulatory developments in the U.S. in November was a hearing held by FDA to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation. IPQ’s coverage encompasses a proposal from Amgen at the hearing on a two-tier process in which interchangeability decisions would trail biosimilar approvals.
Mold contamination and the aseptic processing controls needed to prevent it were high on FDA’s radar screen abroad. Manufacturers in India and the UK have drawn warning letters that shed light on what the agency is most concerned about and why.
Compliance problems continued for J&J’s OTC subsidiary McNeil, with another substantial 483 issued at its Las Piedras, PR facility and another recall of children’s products manufactured at Fort Washington. In a related story, IPQ focuses on Congress’ request for a decade of documents on manufacturing compliance across the industry in Puerto Rico and how the PR district has been handling its oversight responsibilities.
The November Monthly Update also includes insights from an FDA reviewer and a drug investigator on how the reviewer/investigator relationship is deepening and the preapproval process is evolving under the influence of the new quality paradigm concepts.
IPQ’s focus in Europe is on the EMA’s ongoing effort to strengthen its GMPs to better address the challenges of the increasingly complex ingredient supply, manufacturing and product distribution chain and incorporate ICH Q8-10 principles. Emerging for comment were a revised draft of: ● Chapter 7 that expands its scope of coverage from contracting to all outsourced activities, and ● Chapter 5 (production) that provides new requirements for control of the active ingredient and starting material supply chains.
An in-depth analysis of China’s evolving quality regulatory process – with insights provided by former CDER Deputy Director Chi-wan Chen, now directing Pfizer’s global CMC effort – reveals China’s movement toward the Western/international model.
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