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Drug manufacturing

‘Sterility’ problems at Moorfields raised by regulator

The manufacturing arm of the world-renowned Moorfields Eye Hospital has failed to meet production standards.

Eye drop

Serious deficiencies in sterility and sterilisation processes were found at the manufacturer of ophthalmic products

The manufacturing arm of the world-renowned Moorfields Eye Hospital, which produces more than 100 unlicensed medicines and licensed branded products, has failed to meet production standards.

During a visit to Moorfields Pharmaceuticals’ London site in May 2014, inspectors from the UK medicines regulator identified “serious deficiencies” in sterility and sterilisation processes that break good manufacturing practice (GMP) standards.

But the Medicines and Healthcare products Regulatory Agency (MHRA) said that patients were not at risk and did not close the site or issue any product recalls. It said medicines produced by Moorfields Pharmaceuticals should continue to be taken as recommended.

According to information published on the online European database of GMP certificates, which is maintained by the European Medicines Agency, its ‘pharmaceutical quality system’ also fell short of expected standards. The website says that the breaches were associated with “primarily unlicensed medicines made for specific named patients or for small hospital orders”.

“A number of products have been deemed medically critical by the UK and non-critical products within shelf life were recalled from hospitals within the UK by Moorfields Pharmaceuticals.

“The supply of products not deemed medically critical has been suspended. Critical products … should continue to be supplied,” it says.

The MHRA confirmed that it had issued Moorfields Pharmaceuticals with a GMP non-compliance statement and says it is working with the Department of Health to ensure that the production of medicines needed by UK patients continues.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065480

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