Regulatory Focus™ > News Articles > UK's MHRA: Apotex Site Does Not Comply With GMP Requirements

UK's MHRA: Apotex Site Does Not Comply With GMP Requirements

Posted 18 December 2017 | By Zachary Brennan 

UK's MHRA: Apotex Site Does Not Comply With GMP Requirements

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant.

A statement of non-compliance with good manufacturing practice (GMP) requirements highlighted the site’s non-complaint operations related to non-sterile products, packaging and quality control testing.

"Due to the nature of the issues identified, batches not released to market are included in the scope of this SNC [statement of non-compliance]. A new GMP certificate will be issued restricted to products agreed in writing between the marketing authorisation holder and individual competent authorities based on continuity of product supply being critical for continued patient treatment," the MHRA statement said.

The site was previously highlighted for deficiencies by other regulators too.

Back in 2015, FDA inspectors found that a QC microbiologist at the same Apotex site "was observed overwriting the dates for previously read (awaiting disposal) growth promotion plates using a black marker in order to make it appear that the growth promotion testing had been performed previously."

And during a review of the firm’s analytical QC laboratories, FDA identified a company practice of retesting drug product samples when failing and/or otherwise undesirable chromatography results were encountered. FDA also had issues with the company's testing of drug samples.

GMP Non-Compliance


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