Pfizer added to the expanding list of drugmakers for deviating from GMP
Pharma giant Pfizer got added to the latest addition of an expanding list of drug makers who were found deviating from good manufacturing practices in India. A high profile team drawn from world’s four leading regulators identified a number of deficiencies at the company’s Irungattukottai facility, near Chennai. This happened inn the last week of June and now Pfizer has temporarily stopped production at the site.
The site, which makes generic injectable drugs, is grappling with adverse reviews for a few years. It was served a warning letter by the US Food and Drug Administration (FDA) in 2013, which was followed up with a handful of observations.
Pfizer confirmed to ET about the inspection. It was led by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and included US FDA, Therapeutic Goods Administration of Australia and Health Canada, the Canadian drug regulatory agency .
The New York-headquartered pharmaceutical giant informed “it temporarily paused production at the site to allow an assessment of observations by appropriate experts”. It added, “Our colleagues are fully engaged and working towards resuming production as soon as possible. The temporary pause in manufacturing is being utilized to review
the observations, to develop a holistic improvement plan and also to provide additional training to our colleagues at the site”.The injectables unit was formerly owned by Hospira, the injectables maker that Pfizer acquired last year as part of a global $17 billion deal. Hospira had acquired it in 2009 from Orchid Chemicals in a broader $400 million transaction.
“A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations,” Pfizer said, stating the site is dedicated for exports and does not manufacture for the domestic market.The company ruled out any impact on its employees at the site as a result of the latest inspections.
The USFDA and MHRA submitted their inspection observation reports, which Pfizer said it has reviewed in depth. “The site has formally responded to both these agencies and is working diligently to address the specific inspection findings and implement enhancements to site operations,” it noted.
In a statement to ET a spokesperson for Health Canada said a number of deficiencies were identified during the same inspection. “The company is responsible for implementing corrective and preventative actions to address the deficiencies. The information resulting from this inspection is currently under review by the joint inspection team,” the regulatory body added.
An official spokesperson for the US FDA said it does not publicly disclose information about potential or ongoing inspections. Questions to MHRA were not answered until press time.
