Ningxia Taiyicin Biotech Co. Ltd. — EU GMP NCR (EudraGMDP) Findings

The inspection was performed in the context of EDQM programme. The not sterile active substance inspected: Lincomycin hydrochloride/CEP 2017-155. During the inspection, 13 deficiencies classified as “Major” were found. The deficiencies raised highlighted an inadequate approach and management of the GMP activities and evidenced important deficiencies in the quality assurance system; in particular, one of the main deficiencies was primarily based on the dilapidated state of the equipment and facilities used for Lincomycin hydrochloride manufacture. Deficiencies were also raised in the management of documentation, traceability of GMP activities, deviations, OOS. Action taken/proposed by the NCA: Recall of batches already released Consideration of recall, following NCA assessment of potential quality defects vs. supply restriction. A direct product risk could not be identified, however the nature of the Major deficiencies and the cumulative risk of the deficiencies combined could lead to a low-quality product. Each involved NCA should evaluate following assessment conducted in conjunction with MAHs to recommend a full retest of the active substance and medicinal products manufactured with this active substance. On the basis of the AIFA information, no shortage of the medicinal products containing this active substance is in a real risk. In any case, lack of alternative service providers and risk of shortage should be assessed case by case. Prohibition of supply The company should not supply to the EU market whilst the NCS in is force. A successful reinspection is recommended before market supply is resumed. Suspension or voiding of CEP (action to be taken by EDQM) CEP 2017-155 / Lincomycin hydrochloride has been suspended.