U.K. regulator slaps U.S. CMO Pii for GMP lapses

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Another U.S. contract manufacturer has run into problems with European authorities for failing manufacturing standards, leading the European Medicines Agency to announce that its manufacturing certification is being pulled and a recall has been recommended.  

U.K. inspectors went through two facilities of the Hunt Valley, MD-based Pharmaceutics International Inc. (Pii) in February, according to a report on the EU’s Eudora GMDP site. They reported finding what they termed two critical and three major deficiencies.

In an emailed statement, the company pointed out that no recalls have been ordered and that it is working to address all of the issues raised by regulators.

“Beginning in April, 2016, after conducting a thorough search and interview process, Pii brought in a team of experts, each with specialized expertise, to address each of the agency’s substantive areas of concern,” Pii General Counsel Julien A. Hecht  said. “These remediation efforts have the highest priority at Pii and significant resources, in terms of  both dollars and personnel, have and will be expended as part of this process.”  


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The critical issues identified by inspectors included a failure to minimize the risk of cross-contamination between hazardous and non-hazardous products, the report says. Secondly, inspectors said the facility had an unqualified HPLC system and unacceptable approach to production equipment qualification.

In the major deficiency category there were problems with investigating data integrity failures, problems with sterilization and depyrogenation processes, and insufficient control of aseptic operations to provide the required level of sterility assurance.

The report says that among the products Pii ships to the U.K. is ammonaps tablets and powders and lutigest vaginal tablets. The regulator suggests that Pii recall batches already released in the U.K. and intends to prevent any further deliveries until problems are resolved. It said it would consider requests for exceptions in the event the action would impede any clinical trials in the country.

In a response, the company pointed out that "the recent inspections have not resulted in any recalls of any kind of any product manufactured by Pii."

This the second U.S. CMO to be cited by the EMA in recent weeks. Last month, the EMA reported that Sweden’s regulator had pulled the manufacturing authorization of Capsugel’s Bend Research facility in Bend, OR, after uncovering more than 20 deficiencies, including two it deemed critical and 7 that were classified as major. The company has said it is hard at work to resolve the problems.

- access the EMA report here

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