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Pfizer under list of drugmakers for deviating from Good Manufacturing Practices

In the last week of June, a high profile team drawn from world's four leading regulators identified a number of deficiencies related with GMP violations at Pfizer’s Irungattukottai facility, near Chennai. The team included UK's Medicines and Healthcare products Regulatory Agency (MHRA), US FDA, Therapeutic Goods Administration of Australia and Health Canada, the Canadian drug regulatory agency.

Pfizer hence has become a latest addition to an expanding list of drug makers which was found deviating from good manufacturing practices in India. Already a warning letter was issued to Pfizer by the US Food and Drug Administration (FDA) in 2013 for the same site. Due to a number of observations at the same site, USFDA had directed the company to provide a global corrective action plan for its facilities including a comprehensive training module for process operations with details on how the effectiveness of such training programs are measured.

Pfizer has temporarily paused production at the Irungattukottai site to allow an assessment of observations by appropriate experts. The site was formerly owned by Hospira which was later acquired by Pfizer. The temporary halt is being utilized by Pfizer to develop an effective improvement plan after reviewing the observations and to provide additional training to the staff at the site.

The US FDA and MHRA submitted their inspection reports to which the site has formally responded and is working diligently to address the specific inspection findings and implement enhancements to site operations.


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