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Warning letter issued to Mumbai based Megafine Pharma by USFDA

Mumbai based Megafine Pharma has received a warning letter from USFDA on account of violations of Good Manufacturing Practices. Summarizing the violations from cGMP (current good manufacturing practice) norms at the Nasik facility, the US Food and Drug Administration (USFDA) said that its investigator observed several significant deviations including data falsification and failure to prevent data manipulation.

According to US Food and Drug Administration (USFDA), one of the company's analysts acknowledged falsifying test data and "substituted a reference standard chromatogram in place of the 12-month stability interval chromatogram" to which the company responded saying that its laboratory management did not discover the discrepancy until the 24-month stability interval and the batch quality was unaffected.US FDA did not find the reply appropriate as it did not address the extent of the data falsification that could exist in its laboratory.

Some of the violations observed by the company were as listed below:

• Failure to ensure that, for each batch of intermediate and API, appropriate laboratory tests are conducted to determine conformance to specifications." • Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent manipulation and omission of data • The quality system of Megafine Pharma "does not adequately ensure the adequacy and integrity of data to support the safety, effectiveness, and quality of drugs they manufacture • Inadequate investigation of critical deviations or a failure of a batch to meet its specifications or quality standards".

Based on the violations, USFDA has asked the company to do a comprehensive investigation into the extent of the inaccuracies in data records and reporting .USFDA also said that until the company corrects all the deviations and the compliance with cGMP is confirmed it may withhold approval of any new applications or supplements from the company.


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