Avenza Pharmaceuticals Private Limited — EU GMP NCR (EudraGMDP) Findings

This Statement of GMP Non-compliance relates to proposed activities at the Avenza Pharmaceuticals Pvt. Limited site identified above. The company was not compliant with EU-GMP standards. At the time of the inspection the process for manufacture of Paracetamol Tablets had not been appropriately validated, the cleaning process had not been appropriately validated and the inventory management system had not been fully validated. Inspection Outcome: Seven major deficiencies were identified during the inspection. These related to the following areas: • Management of computerized systems. • Cleaning Validation • Process Validation • Physical/Chemistry Laboratory • Investigation of OOS Results • Management of the stability program • Vendor Qualification and Management Action taken/proposed by the NCA: Others Importers variation withdrawn.