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Drug manufacturing

Generics manufacturer Bristol Laboratories regains full good manufacturing practice status

Generics manufacturer Bristol Laboratories’ good manufacturing practice (GMP) status has been fully restored, the company has announced. 

The company was issued with a restricted certificate in August 2017, only allowing them to make medicines deemed critical to the EU market. The suspension is believed to have contributed to shortages in some generic products.

The company’s GMP certificate was partially suspended by the Medicines and Healthcare products Regulatory Agency after inspectors from the European Medicines Agency (EMA) identified issues with quality control and an ongoing stability-monitoring programme intended to monitor products over their shelf life. The EMA also found problems with the integrity and recording of critical data.

In September 2017, the Pharmaceutical Services Negotiating Committee (PSNC) said that “following inspections at Bristol and Dr Reddy’s, [the] PSNC is aware of a number of products that are currently having shortage and pricing issues” and that it was in “urgent discussions with the Department of Health regarding price concessions and wider concerns over the numerous market issues that pharmacy contractors and teams are facing”.

The suspension was lifted on 22 May 2019.

In a statement issued on 2 June 2019, Priti Ramachandran, director of quality and regulatory affairs at Bristol Laboratories, said that the lifting of the suspension “gives vital reassurance for our patients and our customers — as well as our people, our distribution network and our supply chain — as Brexit continues to present uncertainty over future medicine supply in the UK”.

Ramachandran went on to say that while Brexit presented challenges for everyone in the pharmaceutical sector, “we stand ready: we have created enough capacity to address medicine shortages”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206631

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