Falsified Results of Analysis at Indian Pharmaceutical Manufacturer

Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. In a further case the analysis results not complying with the requirements were deleted and the batch was released for the US market. Read more.

http://www.gmp-compliance.org/enews_4629_Falsified-Results-of-Analysis-at-Indian-Pharmaceutical-Manufacturer_9086,9087,9200,9122,Z-PEM_n.html

Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. We recently reported on theunannounced FDA inspections in India as one of the consequences of this practice. In a further case the analysis results not complying with the requirements were deleted and the batch was released for the US market. An employee of Sun Pharmaceutical Industries Ltd. in Vadodara, India simply deleted analytical data of an HPLC testing on impurities of an antibiotic that did not comply. The next day another sample was tested, considered to be fine and the batch was released. This incident took place three years ago.

This fundamental GMP violation of data integrity has become known only now. The…