Lianyungang Guike Pharmaceutical Co. Ltd. — EU GMP NCR (EudraGMDP) Findings

During the inspection of the manufacturing site, in the frame of EDQM’s inspection progamme, 21 deficiencies against EU GMP were identified. One deficiency was classified as critical due to inadequate control of contamination and cross-contamination risk in shared facilities. The risk assessments and contamination control strategy for Workshop 2 and the dispensing area were insufficiently robust, specific, justified, and effectively implemented, notably for exposed product operations, gowning, area and equipment cleanliness, material entry, dispensing activities, and the use of shared equipment for potentially highly potent products. Furthermore, absence of contraindications between APIs manufactured in the shared facility was not evaluated consistently. These represent a potential risk to patient safety. Five deficiencies were classified as major and were related to the following areas: cleaning validation and cleaning procedures, preventive maintenance and equipment condition, data integrity, change control management, and batch release and compliance to CEP. In addition, 15 other deficiencies were found (i.e. records, quality system, personnel training, calibration, labelling management, equipment qualification). Action taken/proposed by the NCA: Requested Variation of the marketing authorisation(s) For medicinal products containing APIs manufactured by LIANYUNGANG GUIKE PHARMACEUTICAL CO. LTD. in Workshop 2, assessment of the MA to remove or substitute this manufacturer of active substances and intermediates should be considered. In addition, no new MAs should be granted for products relying on this API source while the statement of non-compliance remains in force. Recall of batches already released If there are alternative suppliers and there is no risk of shortage, recall of medicinal product should be evaluated by the involved NCAs following assessment conducted in conjunction with MAHs. Prohibition of supply Due to the nature of the non-compliance, prohibition of supply is recommended, unless there are no alternative suppliers and there is a risk of shortage. Suspension or voiding of CEP (action to be taken by EDQM) The EDQM had taken the decision to suspend all granted CEPs from LIANYUNGANG GUIKE PHARMACEUTICAL CO. LTD. CEP 2013-019 Atracurium besilate CEP 2021-236 Cisatracurium besilate CEP 2017-271 Entecavir monohydrate (intermediate)