Glukem Biocare Private Limited — EU GMP NCR (EudraGMDP) Findings

The inspection resulted in a critical deficiency related to contamination risk in the Fluid Bed Coating (FBC) equipment due to an observed pool of liquid and residue in a section of the inlet air plenum of a fully cleaned FBC. The flaws were due to common design between FBCs (inclination of plenum not allowing gravity draining) and inadequate cleaning procedure. In addition, there was no detectability of a failure in HEPA filter integrity through real-time monitoring of pressure differential before and after the supply air HEPA filter of the Air Handling Units of the FBCs. There were eleven (11) major findings relating to: Inadequate Master Batch Record instructions and production documentation; Deficient process validation, including insufficient coverage of process, demonstration of its reproducibility and pellet homogeneity; Incomplete cleaning validation; Differential pressure excursions; Deficient warehouse, sampling and dispensing controls; Inadequate vendor qualification; Inadequate identification testing of incoming starting materials, Excipient risk assessments, Out-of-Specification handling, Equipment qualification and Pest control. Action taken/proposed by the NCA: Revocation of the marketing authorisation(s) Member states should consider not initiating or authorising new marketing authorisations with this site listed as an intermediate product manufacturer until the recommended non-compliance statement to be issued remains in place or is not superseded with a GMP certificate. Prohibition of supply No products batches manufactured at the site should be released to EEA markets until this non-compliance remains in place or is superseded by an EU GMP certificate.