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Mergers a “key problem” for regulatory compliance, drug quality expert says

By Nick Taylor , 29-May-2012

Biopharma mergers are a “key problem” for manufacturing quality teams as the loss of focus can lead to regulatory actions, a compliance expert said.

Merger-related quality problems stem from the shift in company focus away from compliance with drug production to integrating the acquisition. However, by focusing on the merger and the financial side of the business, biopharma firms risk harming their reputations and ultimately losing money.

Speaking at Interphex Rosario Quintero-Vives, senior regulatory and compliance specialist at RQV Consulting, told in-PharmaTechnologist the loss of focus is behind “when you see companies with a great history…suddenly getting a 483 by the FDA (US Food and Drug Administration)”.

Johnson & Johnson is one company that has faced merger-related quality deficiencies. Last year an internal investigation into failings at J&J found the vice president for quality at its subsidiary, McNeil, “spent a significant amount of his time focusing on other matters”, such as integrating acquisitions.

In 2006 J&J bought the consumer health business from Pfizer. The report found integration of these assets, such as adding product lines to two sites, occupied the McNeil VP throughout 2007 and 2008.

At an internal meeting in September 2008 the consumer health team at J&J reported that of the 21 recalls in the prior two years, more than 70 per cent were linked to the assets bought from Pfizer.

Problems really began in the next two years though, when a succession of recalls and quality failings led to the signing of a consent decree in 2011. The consent decree included production plants in Puerto Rico and Pennsylvania, both of which had production lines added to handle the Pfizer buy.

Retaining a focus on quality can help avoid these problems. “When you are doing a merger the most important thing is never lose track of your quality. If you compromise quality you compromise your manufacturing date and you get into backlog. And you lose money. That’s the most important thing.”

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