The French regulator actually finds several deficiencies at Biocon’s Bengaluru facility especially for the bio-similar. Related to the pending applications of the Biocon for pegfilgrastim, trastuzumab and also the insulin glargine, the quality check would be made. The French based drug regulator has discovered the lapses at the Bommasandra facility of the Biocon in Bangalore regarding GMP (Good Manufacturing Practices) for the different activities related to the three various bio-similar products. ANSM which is the French National Agency for the Medicines and Health Products Safety examined the Bengaluru plant of Biocon for the EMA (European Medicine Agency) between 13th March and 17th March.
This agency was actually reviewing such three different bio-similar products of Biocon which are Ogivri (Trastuzumab), Fulphila (Pegfilgrastim) and Semglee (Insulin Glargine) for obtaining official marketing authorization in the European Union. French National Agency for the Medicines & Health Products raises totally 35 deficiencies which has 11 major deficiencies regarding the bio-similar products.
The French Regulator got to know that Good Manufacturing Practices or GMP deficiencies, cleaning validation, environmental monitoring training, OSS which is Out of Specifications results management, media fill test, process validation, batch manufacturing record, vendor’s qualification, cross contamination risks, access management in SAP for the batch certification, and differential pressure alarm’s management in the classified areas.
In the report of the ANSM, it suggested suspension of the prohibition of supply and marketing authorization of the three various bio-similar products until such related deficiencies are resolved. This agency as well as said the report on GMP inspection is requested for ensuring that the whole Corrective and Preventative Actions which is CAPA plan has been applied and finalized by the site and that the best quality system is currently in the place.
In the associated development, ANSM has issued certificates on the GMP compliance for the two facilities of Biocon in Bengaluru which manufacture active substance of Pegfilgrastim and Trastuzumab.