Pfizer adds to list of drugmakers under lens for deviating from good manufacturing practices

Pfizer is the latest addition to an expanding list of drug makers found deviating from good manufacturing practices in India.In the last week of June,a high profile team drawn from world’s four leading regulators identified a number of deficiencies at the company’s Irungattukottai facility, near Chennai 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 le .. 

 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 

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”. 

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.