update

UK MHRA finds cross contamination risk at Apotex's Bangalore plant

By Gareth Macdonald contact

- Last updated on GMT

Apotex Research Private Limited (ARPL) plant in Bangalore, India (source Apotex website)
Apotex Research Private Limited (ARPL) plant in Bangalore, India (source Apotex website)

Related tags: Regulation, European union

UK regulators have banned Apotex Research Private Limited from shipping drugs made at its plant in Bangalore, India to the EU after inspectors raised concerns about the potential for cross contamination.

The Medicines and Healthcare products Regulatory Agency (MHRA) detailed its concerns about the facility – which is located in the Bommasandra Industrial Area - in a report​ on the EudraGMDP database.

The agency said, “The inspection in November 2017 identified failures in the cross-contamination controls applied by the manufacturer resulting in a risk of cross contamination above Permitted Daily Exposure (PDE) from some products​.”

In addition to prohibiting the shipment of drugs to the EU, the agency also recommended withdrawal of the site's good manufacturing practice (GMP) certificate.

The only products not covered by the ban are those likely to be in short supply. In such circumstances, Apotex will be able to continue supply if the marketing authorisation holder gains written approval from the regulator in the intended market.

The agency also advised member states to “contact the site to determine the level of risk associated with specific products released to market.

MHRA would recommend 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 added.

An agency spokesman told us “Following a routine inspection of the Apotex site in Bangalore, MHRA have issued a conditioned statement of non-compliance and a restricted GMP certificate to allow continued supply of specific critical products in the EU. 

Medicines produced at the site are not marketed in the UK. People should continue to take their medicines as prescribed. If anyone has questions about their medication they should speak to their doctor​.”

Apotex did not respond to a request for comment.

Related topics: Regulatory & Safety, Regulations, QA/QC

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