Megafine Receives FDA Warning Letter Over Data Integrity IssuesBy
Megafine Pharma, a Mumbai, India-headquartered manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates, has received a Warning Letter from the US Food and Drug Administration (FDA) related to data integrity issues and deviations from current good manufacturing practices (cGMP) for drugs at its Gujara, India manufacturing facility. The violations were noted during an FDA inspection of the facility from September 19 to 23, 2016, and the agency reviewed Megafine’s response on October 14, 2016 and has acknowledged receipt of subsequent correspondence.
During its inspection, the FDA observed that Megafine did not insure data integrity by failing to implement scientifically sound test procedures capable of demonstrating the purity of the drugs produced and that the company’s quality assurance unit was using blank pre-approved and signed documents for analysts to fill out. The FDA also observed cGMP violations that included the approval by the company’s quality unit for the use of adulterated material from a facility on FDA’s import alert list to manufacture an API intermediate and the failure to establish and follow written procedures for cleaning equipment used to manufacture APIs as well as maintaining records of major equipment usage.
In response to the cGMP violations, the FDA requires Megafine to provide the following: an action plan to ensure the quality of its drugs by notifying customers about adulterated material in the drug manufacturing process and recalling any adulterated drugs for US distribution still within expiry; stability testing and analysis from an independent laboratory for all lots of drugs within expiry for US distribution; a summary report of any corrective actions that the company has implemented or plans to implement based on a consultant’s review of stability studies; chemical identification of the observed residue in the inadequately cleaned equipment and a risk assessment to determine the impact of the residue on drugs within expiry in the US supply chain; and a complete assessment of an equipment preventive maintenance program including necessary procedure revisions to ensure the equipment is suitable for use in manufacturing.
For the data integrity violations, the FDA requires Megafine to provide the following in its response: a comprehensive investigation into the extent of the inaccuracies in data records and reporting; a current risk assessment of the potential effects of the observed failures on the quality of the drugs manufactured at the facility, including analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and risks posed by ongoing operations; and a management strategy that includes the details of global corrective action and a preventive action plan.
This Warning Letter follows an earlier Warning Letter that Megafine received from the FDA in May 2016 also for data integrity violations and cGMP violations for APIs at its facility in Maharashtra, India.
Source: Food and Drug Administration