MHRA Finds Cross-Contamination Risks at Recipharm Manufacturing Site
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has found contract manufacturer Recipharm’s Ashton-u-Lyne, UK-based manufacturing facility does not comply with the Good Manufacturing Practice requirements.The statement of noncompliance means that MHRA has restricted the manufacturing license for five non-critical highly potent products supplied from the site, Recipharm said.
In terms of the nature of the non-compliance, MHRA said the site’s measures to prevent and detect cross-contamination “were deficient and presented a risk that cross-contamination between products could occur and would not be detected.”
The site operates separate manufacturing areas for potent and non-potent products, and MHRA said that in particular, the potential for cross-contamination with highly potent products “poses a risk to public health and the National Competent Authority therefore believes that it is necessary in the interests of patient safety to immediately restrict the manufacture of non-critical potent products until the issues are satisfactorily resolved.”
Recipharm said its remediation plans “have been endorsed by the MHRA and are being executed. Supply has recommenced and will continue in a phased manner for the non-restricted products. It is unlikely that this issue will cause significant supply interruptions to patients and it is expected that the licence restriction will be completely lifted by the end of the year.”
MHRA also acknowledged that the site may need to manufacture non-critical potent products as part of cleaning trials to return to compliance. The regulator has allowed such action “provided that it is supported by a documented risk assessment containing sufficient information to support the activity on a risk management basis. However, these products may not be released to market whilst the restriction is in place.”
MHRA also lists all of the potent products manufactured at the site in its statement of noncompliance.