Swiss Parenterals Limited — EU GMP NCR (EudraGMDP) Findings

Onsite inspection identified 7 critical and 9 major deficiencies. Critical deficiencies relate to: 1. The pharmaceutical quality system does not effectively encompass the specific requirements for sterile product manufacturing, as evidenced by inadequate deviation management and the lack of effective implementation of risk management and risk-based decision-making. 2. During the observation of production activities and review of selected smoke studies it was noticed that interventions were often poorly designed, and aseptic techniques, operators qualification, training, behaviour, and practices in many cases did not comply with the requirements of EU GMP Annex 1. 3. The manufacturer failed to supply the requested documentation promptly and transparently during the inspection. There are concern about authenticity and control of documentation, and there is insufficient assurance that records are attributable and contemporaneously generated. 4. Deficiencies were identified in the design of premises and equipment (including lack of appropriate barrier systems), handling of disinfectants, garment washing procedures, coverage of all processes during APS, omission of products from cleaning validation matrices, inadequate design of airflow visualisation studies, and absence of a validated procedure for CCIT of ampoules. 5. Inadequate equipment and process design for dispensing, sampling and blending, as well as inadequate design of manual interventions manual interventions related to handling of sterile powders. 6. Inadequate material transfer pathways and processes. 7. Inadequate OOS investigations. The major deficiencies are related to: pharmaceutical quality system, sanitary/hygienic practices, premises and equipment, production, quality control, qualification and validation, aseptic process simulation (media-fill), cleaning validation and cleaning practices, computerized systems. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. 530-10/24-06/07, 381-13-08/284-25-13 Current certificate 530-10/24-06/07; 381-13-08/284-25-13 will be withdrawn. Suspension of the marketing authorisation(s) Member States should consider not authorising marketing authorisation applications/variations to marketing authorisations with this site listed as a finished product manufacturing site until the non-compliance statement remains in place. Recall of batches already released Recall of medicinal products should be considered where potential quality defect has greater impact to public health than supply restriction in affected Member State(s). Prohibition of supply Following issuance of the final Statement of non-compliance with the principles and guidelines of GMP and as long as it remains in place, the prohibition of importation and/or supply from the site should be considered.