Apotex’s Solid-Dosage Manufacturing Plant in India Cited for GMP Violations
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued to Apotex, a generic-drug company, a statement of non-compliance with good manufacturing practice (GMPs) for its solid-dosage manufacturing facility in Bangalore, India.
The statement was posted on EudraGMDP, a database of the European Medicines Agency providing information from the national regulatory authorities of the member states of the European Union, Iceland, Liechtenstein and Norway , on manufacturing and import authorizations, GMP certificates, statements of non-compliance with GMP, GMP inspection planning in third countries, and related information on good distribution practices.
An inspection in November 2017 identified failures in the cross-contamination controls applied by the company resulting in a risk of cross contamination above permitted daily exposure from some products. The company’s non-compliant manufacturing operations included: non-sterile products (hard-shell capsules and tablets); packaging (primary packaging [hard-shell capsules and tablets] and secondary packaging); and quality-control testing (microbiological: non-sterility and chemical/physical).
The MHRA has withdrawn its previous GMP certificate. Due to the nature of the issues identified, batches not released to market are included in the scope of the statement of non-compliance. The report says that no batches are to be supplied to EU markets while the statement of non-compliance remains in force with the exception of products agreed in writing between the marketing authorization holder and individual competent authorities based on continuity of product supply being critical for continued patient treatment. A new GMP certificate will be issued restricted to products agreed in writing between the marketing authorization holder and individual competent authorities based on continuity of product supply being critical for continued patient treatment.
The report says that EU member states should contact the site to determine the level of risk associated with specific products released to market. The MHRA is recommending consideration of recall of any products where success of cleaning is not supported by swab testing at product changeover and where the visual threshold is not equivalent to or lower than swab limits. It says as this may be difficult for the site to substantiate in the short term, it should be considered if precautionary recall should be applied.
Source: European Medicines Agency