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Regulatory Focus™ > News Articles > EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

Posted 19 August 2016 | By Zachary Brennan 

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Pfizer decided to temporarily suspend operations at the site earlier this month and MHRA is now calling on EU member states’ National Competent Authorities to evaluate how critical the products supplied by this manufacturing site are for their respective markets, and to enact measures to ensure continued supplies where appropriate.

“Pfizer has formally responded to the inspection findings issued following the recent inspection of the legacy Hospira Irungattukottai, India site. The site is implementing actions to address the findings,” Pfizer spokeswoman Kim Bencker told Focus when the site first announced the shutdown on 8 August. “Patient safety is of utmost importance to Pfizer, and Pfizer is committed to ensuring the safety and quality of our medicines.”

Marketing authorization holders are requested to contact the European Medicines Agency or relevant national authority to verify whether their products are considered medically critical.

“Where manufacture and/or testing is continued for critical products, this should be supported by a documented risk assessment containing sufficient information to support activity on a risk management basis,” the statement says.

Joint Inspection

The unique inspection was conducted by officials from four regulators - a rarity in a world where manufacturing sites often get reinspected by the same authorities) - including the US Food and Drug Administration (FDA), MHRA, Australia’s Therapeutic Goods Administration (TGA) and Health Canada.

Anna Maddison, a spokeswoman for Health Canada, told Focus: “The inspection of this Pfizer facility in India was the first joint inspection that Health Canada conducted simultaneously with the MHRA, TGA, and the US FDA.”

As far as whether this inspection will be part of a larger trend of joint inspections, Maddison said: “Health Canada works closely with its international partners towards a path of greater collaboration and work sharing, with the objective of providing comprehensive oversight of foreign manufacturing facilities. Health Canada is involved in a number of initiatives with international partners such as the Mutual Recognition Agreement with the European community, the Regulatory Cooperation Initiative with the TGA and the Regulatory Cooperation Council with the US FDA.”

FDA spokesman Kris Baumgartner also told Focus: "FDA frequently conducts joint inspections with its regulatory partners in the international arena and there are a number of reasons that trigger this collaboration. These activities serve to build confidence in other regulatory systems, promote a better understanding of the systems within these regulatory bodies, and also promote information sharing between regulators that ‎have common objectives."

The cooperative inspection also followed an FDA warning letter for the site in May 2013 and a FDA Form 483 with 23 observations from January 2014.

Inspection Details

According to the MHRA, “The inspection identified a critical finding that was in regards to sterility assurance of product. The deficiency covered a number of areas including building classification and segregation by pressure differentials, aseptic processes that had not been optimised to reduce the risk of microbial contamination, aseptic process simulation investigations that failed to identify root cause and take appropriate actions.”

The report also found that the environmental monitoring program “was not based on a scientific justification and a number of areas of critical risk were not monitored,” while sterilization activities featured “poorly designed autoclave load patterns that presented occluded surfaces and areas that were not free draining, SIP process that had pipework that was not appropriately sloped and also had manual interventions that were not appropriately detailed and all of the above issues were linked to a lack of scientific knowledge.”

The statement also called for the withdrawal of the site’s UK GMP certificate and said: “No future batches of non-critical Sterile product to be supplied to the EU while this statement of non-compliance remains in force. This prohibition does not apply for solid-dosage products such as tablets and capsules.”

Pfizer’s site, acquired from Hospira in 2015 as part of its $16 billion acquisition, produces at least 19 medicines, mostly antibiotics, including imipenem/cilastatin, meropenem, piperacillin/tazobactam, cefuroxime, ceftriaxone, ceftazidime and cefuroxime.



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