Non-Compliance by Indian Drug Manufacturer: Cross Contamination

Recommendation

17-19 September 2024

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GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms

So-called Non-Compliance reports are summaries of inspections conducted by European inspectors. They are publicly available on the EMA’s (European Medicines Agency) website. In the present case, the Non-Compliance Report is based on the inspection of an Indian pharmaceutical manufacturer in Bangalore, which was conducted by the MHRA in November 2017.

The report concerns the manufacturing of non-sterile dosage forms: tablets and capsules as well as their primary and secondary packaging. The inspectors found the cleaning procedure and the proof of cleaning success during product changes to be inadequate. As a result of the inspection, the GMP certificate was withdrawn. Due to the severity of the deficiencies found and the resulting cross contamination risk, the MHRA recommends a precautionary recall of all affected batches in the market.

Source: EudraGMDP Database