Liaoyuan City Baikang Pharmaceutical Co. Ltd. — EU GMP NCR (EudraGMDP) Findings

The inspection team identified 25 deficiencies against EU GMP. Of these, one was classified as critical and found in the area of data integrity controls in the QC laboratory. In addition, five deficiencies were classified as major and related to controls regarding product release from the site, contamination risks arising from inadequate maintenance and cleaning of equipment, buildings and facilities, records of GMP activities, out-of-specification investigations in the QC laboratory, and cleaning validation. The remaining 19 deficiencies were classified as other. Action taken/proposed by the NCA: Prohibition of supply After issuance of the non-compliance report and as long as it remains active, the site should not be authorized to distribute active ingredients for pharmaceutical use. Suspension or voiding of CEP (action to be taken by EDQM) EDQM withdrawal of CEP 2007-054 – Paracetamol