MHRA suspends GMP certificate for Pfizer site in India
The UK’s Medicines and Healthcare Products Agency (MHRA) has recommended that an Indian facility belonging to Pfizer’s Hospira unit be banned from supplying some drugs to the EU after their inspectors found numerous breaches of manufacturing regulations during an inspection in July.
Pfizer temporarily suspended site operations earlier this month, and the MHRA has urged member states to cease the acquisition of all non-critical products from the facility.
The inspectors found numerous sterility and other manufacturing problems, which caused the regulator to revoke the Sriperumbudur facility’s good manufacturing practice certificate. The plant was first cited with an FDA warning letter several years ago, before Pfizer bought Hospira
The import of six injected antibiotics in 19 total dose forms have been banned from entering the EU, which include Piperacillin/Tazobactam and Cefuroxime.
As part of their report, the MHRA found “aseptic processes that had not been optimised to reduce the risk of microbial contamination” and that “the environmental monitoring program was not based on a scientific justification.” Furthermore, they found that many of the shortcomings were linked to employees who didn’t have the required “scientific knowledge” to fix these issues.
The MHRA concludes: “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.”
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