28/29 April 2020
Prague, Czech Republic
The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and its related Q&A documents have given the cross contamination topic greater importance. The topic cleaning validation is also affected.
Recently, the British Regulatory Authority MHRA has published a "Non-Compliance with GMP" report in the Eudra-GMPDP database. Non-sterile dosage forms (oral and solutions) both for human use (including clinical samples) and derived from animals are concerned. Here, the MHRA proceeded in a targeted manner and suspended the manufacturing authorisation only partially to ensure a continuous market supply. That's why the production of medicinal products with highly potent active substances continues to be permitted. Although the company had voluntarily stopped the manufacture and the release of the products affected, the MHRA suspended the manufacturing authorisation partially. The MHRA acknowledges that the company has to manufacture products as part of cleaning trials. This production may only occur on a risk management basis. The products may not be released to market whilst the restriction is in place.
The 3-page report lists all the affected medicinal products with their authorisation procedure and export country. You can find the complete Non-Compliance Report in the EudraGMPDP database.