Institute of Good Manufacturing Practices India
Global accredited training provider
Approved by Quality Council Of India (QCI), Government of India
An ISO 9001:2008 Certified Organisation
Registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
New Delhi | Noida | Hyderabad | Lucknow

Trusted by training participants in over 20 countries


Warning given to Sri Krishna Pharmaceuticals by FDA on serious quality control violations

Sri Krishna Pharmaceuticals Limited (SKPL) is the pioneer in the manufacture of ACETAMINOPHEN (PARACETAMOL) for the domestic market and is today a renowned and leading supplier of more than 150 niche drugs for global customers.

The US Food and Drug Administration observed numerous issues at Sri Krishna Pharmaceuticals during a December 2014 inspection, concerning data integrity that involved laboratory records, computer systems, validating processes, and manipulating records of batches of drugs. According to US FDA, Sri Krishna failed to establish adequate written procedures to assure manufactured drugs have the stated strength, quality, and purity. The company was destroying original batch records and then backdated replacements pages that were approved by quality and production managers. And lab records did not contain all of the raw data generated during testing for finished drugs, which meant the quality control unit relied on incomplete records to decide which batches to release for regulatory reviews.

It was also found that the company was destroying original batch records and then backdated replacements pages that were approved by quality and production managers and lab records did not contain all of the raw data generated during testing for finished drugs, which meant the quality control unit relied on incomplete records to decide which batches to release for regulatory reviews. Moreover the company was found to ship certain batches of product to the United States that were made with an invalid process with new equipment.

According to the warning letter issued to the company on April 1st by FDA, the company failed to sufficiently correct the problems.


IGMPI

More

Contact Us