Non-Compliance Report due to Deficiencies in Documentation Management and Cleaning Validation

Recommendation

22/23 February 2024
Munich, Germany

API Regulatory Starting Materials
Definition, Manufacture, Assessment and handling post-approval Changes

At the end of August this year, Maltese GMP inspectors paid the Indian pharmaceutical company "Mercury Laboratories Ltd." a visit. As a result of this inspection, a "Statement of Non-Compliance with GMP" was published two months later on the EudraGMDP website. This statement describes violations of the Good Manufacturing Practice. In total, the inspectors found one critical violation and 18 further deviations (6 "major" and 13 "other").

The critical violation of GMP concerns the poor documentation management operated by the company.

• Manufacturing records and documents risk assessments couldn't be verified.

The following "major" GMP deviations were observed:

• Process validation is insufficient and doesn't provide evidence that the medicinal product consistently produces a product meeting its specifications and quality attributes.
• The qualification/approval system of suppliers is inappropriate.
• The microbiological laboratory and quality control laboratory do not work properly.
• The quality assurance system and documentation management are inadequate.
• Cleaning validation is insufficient; cross contaminations cannot be excluded.

Since this inspection was the first one performed by the authority of an EU Member State, no GMP certificate could thus be issued for this site. So far, the products haven't been listed in any marketing authorisation applications for medicinal products. This means that no product (neither authorised nor to be authorised) within the EU is affected. Nevertheless, the authority who performed the inspection and issued the Non-Compliance Report recommends to disregard this Indian manufacturing site in authorisation or variation procedures due to its poor GMP-status.

Source: EudraGMDP database