Givaudan-Lavirotte — EU GMP NCR (EudraGMDP) Findings

During this inspection, 15 deficiencies were observed, out of which 10 were classified as major // E1[Major] : failures related to deviation management // E2[Major] : insufficient documentation of the quality risk related to the temporary cessation of the company’s activities between April 10th, 2022 and July 29th, 2022 // E3[Major] : insufficient quantity of staff, particularly concerning Quality Assurance and Qualification-Validation activities // E4[Major] & E5[Major] : major defects in the design and maintenance of all the facilities inspected // E7[Major] : multiple and repeated failures in the cleaning of equipment used for the manufacture of starting materials for pharmaceutical use, concerning all inspected workshops // E8[Major] : failures concerning traceability of the operations performed on equipment // E9[Major] : multiple and repeated deficiencies in the upkeep and maintenance of equipment used for the manufacture of starting materials for pharmaceutical use // E12[Major] : repeated weaknesses in the correction of anomalies related to equipment qualifications // E15[Major] : shortcomings in the management of cross-contamination risks, highlighted by deficiencies in the verification of the effectiveness of the cleaning methods applied in the multi-product workshops 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 starting materials for pharmaceutical use Suspension or voiding of CEP (action to be taken by EDQM) EDQM to consider the suspension of several CEPs : CEP 2016-127 (Calcium glucoheptonate) // CEP 1996-106 (Calcium glycerophosphate) // CEP 1999-164 (Ferrous gluconate hydrate) // CEP 2012-221 (Zinc gluconate)