Withdrawal of GMP certification from Indian manufacturer by Italian Medicines Agency

Italian Medicines Agency has issued a warning letter to the Hyderabad based Sri Krishna Pharmaceuticals due to GMP deviations. Sri Krishna Pharmaceuticals is about 25 years old company  and is active in the business of APIs, Direct Compression Granules, Drug Delivery Systems, Vitamins, and Nutraceuticals.

The company has got the warning letter on account of 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.

The inspector found that the PC administrator privileges were routinely altered to control date and time settings until passing or undesirable results were obtained and also for overwriting the previously collected failing and or undesirable sample results. Hence the drugs were not rejected even when they failed to meet the established quality control criteria. Moreover it was also found by the inspectors that without prior performing the official analysis trial injections of sample aliquots were done by the employees at Sri Krishna. The results of the trial injections which were not reported mismatched with the reported results. The resulting raw data chromatogram files were often found to have been deleted and unavailable for review.

System validation requirements were not met by the electronic records according to which the electronic records should be trustworthy, reliable and equivalent to paper records. Controlled manufacturing batch records were found torn and discarded for a variety of products which were issued by the Quality Assurance Unit. The inspectors took five batches for review and on comparison with the archived manufacturing records found that no duplicate issuance for these five batches were done.

Based on the above findings the regulators said that the GMP certificate issued in March and November 2013 are invalid and also proposed to withdraw the GMP certificate issued by Baden Wurttemburg (Germany) issued on 04 August 2014.

According to the Italian agency as there are no quality related issues of the batches of the finished products therefore no ban has been put on the products. This was ascertained on the basis of the fact that only intermediate granules to be processed further by other manufacturing plants of finished products are manufactured in the inspected units. The finished product is further tested by the batch release site before the release on the market. However  National Competent Authorities will consider recall of already released batches and stop supply of further batches of Sri Krishna Source Granules if they find that no full testing including the impurities have been performed before release into the market. Alternatively, National Competent Authorities may request Marketing Authorization Holders to conduct a risk assessment in order to evaluate the risk to the product quality and patients from the issues identified.

The GMP certificate withdrawal has no impact on any of the Sri Krishna’s API manufacturing sites.