Leading CDMO Recipharm’s UK facility fails GMP inspection

By PharmaCompass

2018-10-25

Impressions: 210 Article

A solid dose facility in the United Kingdom, belonging to leading global pharmaceutical contract development and manufacturing organization (CDMO) — Recipharm, failed a GMP inspection conducted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Located near Manchester, the site had over 50 years of experience in manufacturing and packaging tablets and capsules. While the site specializes in potent products and holds a controlled drugs license, the inspection found that the measures to prevent and detect cross-contamination were deficient. Moreover, it carried a risk of cross contamination between products going undetected.

The statement of non-compliance also applies to manufacture of all potent investigational medicinal products (IMPs) manufactured at the site. The only exemption to this is where a trial sponsor can demonstrate that the benefit risk ratio remains positive and supports the continuation of the particular trial.

According to the statement, Recipharm voluntarily stopped the manufacture and release of potent products until corrective actions had been completed. However, for the avoidance of doubt, the MHRA considered it necessary to formalize this commitment by restricting that part of the certificate until the time it is satisfied that potent product manufacture is in a position to return to compliance with the principles of GMP.

The restriction does not apply to the manufacture of non-potent products or to QC testing or to batch certification of sterile products.

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