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Major GMP violations at API manufacturers in India and China

Two Non-Compliance reports were issued at the end of last year at API production sites in China and India. GMP inspectors from the French competent authority found 2 critical and 4 "major" deficiencies at Chinese Manufacturing company “Minsheng Group Shaoxing Pharmaceutical Co. Ltd”which are summarised below:

• Falsification of source of starting materials: the starting materials supposed to have been manufactured in-house actually came from an external non GMP-compliant supplier and have been repackaged and relabelled accordingly (critical deficiency).
• The API manufactured according to the Chinese Pharmacopoeia was wrongly and intentionally released as USP quality; there was no traceability of the testing activities (critical deficiency).
• The cleaning and maintenance operations of the manufacturing line were insufficient (major).
• Deficient equipment design (pipelines); non-compliant transfer of the intermediate solution using nitrogen; non-compliant change management with regard to equipment (major).
• Hoses were lying on a dirty floor of an area not mentioned in the general layout of the site. Those hoses were unidentified and their cleaning status was unclear (major).
• Audit trail function in the chromatographic system was deactivated; there was no procedure in place for audit trail (major).

In India “AstraZeneca Pharma India Ltd” was inspected by Swedish competent authority who found the below major GMP non compliances:

• The manufacturing process of the API was not sufficiently validated (major).
• The documentation routine was not GMP-compliant (major).
• Data integrity wasn't assured (major).
• Design and maintenance of the equipment was insufficient (major).

The non- compliances observed were those laid down in ICH Q7 Guideline and in the EG GMP Guide Part II.



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