20/21 November 2019
On 5 July a Non-Compliance Report (NCR) of the French National Agency for Medicines and Health Products Safety (ANSM) was published on the EudraGMDP site. Between 13 and 17 March 2017, the ANSM performed a pre-approval inspection at Biocon Limited in Bangalore, India, on behalf of the European Medicines Agency (EMA). During that inspection, it was considered that the manufacturing of three biosimilar products does not comply with the Good Manufacturing Practice requirements according to the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC.
The inspection showed noncompliant manufacturing operations amongst others in aseptically prepared Lyophilisates and small volume liquids, in secondary packaging and in the microbiological, chemical and biological quality control testing. The report summarized the following issues for three products:
"Fulphila® (Pegfilgrastim), pre-filled syringe presentation: drug product manufacture (block B1) and quality control operations; - Ogivri® (Trastuzumab), vial presentation (freeze-dried product): drug product manufacture (block B1) and quality control operations; - Semglee® (Insulin glargine), cartridge presentation: secondary packaging (block B2) and drug product quality control. This NCR is limited to the drug product manufacturing activities related to these 3 products. This inspection raised 35 deficiencies, including 11 major deficiencies on the following topics: -Environmental monitoring -Training; -OOS results management ; -Cleaning validation ; -Process validation; -Vendors qualification; -Media fill test; -Cross-contamination risks; -Batch manufacturing record; -Differential pressure alarms' management in classified areas; -Access management in SAP for batch certification"
According to the Non-Compliance Report, the Marketing Authorisation for these products is still under assessment, and as long as the NCR is in force, no batches of these products manufactured prior to the issuance of the report should be supplied to Europe.
For more details please see the statement of non-compliance with GMP.