Bda Health Care Private Limited — EU GMP NCR (EudraGMDP) Findings

First GMP inspection performed at the above-mentioned site by an EU Competent Authority on the 3rd – 8th December 2022. The company applied for a GMP certificate with the scope of non-sterile medicinal products, including capsules, hard shell; tablets (coated and uncoated); sachets and pellets. Microbiological non sterility and chemical/physical QC control are also carried out at this site. The inspectors found four critical, five major and seven other deficiencies. The Inspection Review Group (IRG) meeting at the Malta Medicines Authority has met and decided that a Statement of Non-Compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC is to be issued about the site. Main inspection findings: Four critical and five major deficiencies were found during the course of this inspection. The critical findings are related to -data integrity issues -issues found in the quality control laboratory -qualification and validation activities -manufacturing activities, Good Manufacturing Practice and relevant manufacturing areas Major deficiencies were found in the areas of: -archival of GMP documentations -supplier qualification and approval -sampling of starting materials -Technical Agreements -Quality Management System, including Quality Risk Management For further details the post-inspection letter (dated: 28th December 2022) that lists all findings is available by request. Since this site does not have a valid EU GMP certification no medicinal products should be on the European market. Action taken/proposed by the NCA: Others No marketing authorisation applications, line extensions or variations to existing marketing authorisations, applications should be authorised with this site as a new site of manufacture.