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French National Agency выявил два критических несоответствия в Dongying Tiandong Pharmaceutical Co., Ltd.

Добавлено: 07 мар 2016 15:05
French National Agency for Medicines and Health Products Safety выявил два критических несоответствия в Dongying Tiandong Pharmaceutical Co., Ltd.

Nature of non-compliance : Overall, 10 deficiencies were observed during the inspection, 2 Critical and 3 Major deficiencies: [Critical 1] PCR results of Crude Heparin showing the presence of ruminant DNA received from approved suppliers were manipulated. There was no evidence that the samples retested came from the same batch tested initially; [Critical 2] The quality system implemented by the company for ensuring the full traceability of crude Heparin was identified as very weak : e.g., the traceability from slaughterhouses/abattoirs was not available and not assessed during the audits of the suppliers (lack of supporting documents for the received lots) ; [Major 1] Misunderstanding of the basic GMP principles for handling of out of specification (OOS) results and deviations (e.g., 7 batches of crude Heparin received in 2014 and 2015 were obtained OOS for potency and used for the manufacturing of finished APIs without any OOS investigation); [Major 2] The evaluation of the new suppliers of crude Heparin was deficient: the procedure was not followed, no delivery documents were available, the testing was not systematically recorded in the equipment logbook, the samples from approved suppliers were contaminated during the sampling operation, etc. ; [Major 3] The assessment of 1 H NMR spectrum (Heparin Sodium) and 13 C NMR (Enoxaparin Sodium) used for identification test were deficient (e.g., the presence of an additional peak at the C13 NMR obtained by a subcontracted laboratory was not identified and investigated)

Action taken/proposed by the NCA :
Withdrawal, of current valid GMP certificate No. GIF-IW-N-4022/68/13
Using QRM principles, consideration of withdrawal of current valid EU GMP certificate issued by the Main Pharmaceutical Inspectorate of Poland (GIF-IW-N-4022/68/13).

Requested Variation of the marketing authorisation(s)
Using QRM principles, the removal of the site from MAs should be considered.

Recall of batches already released
Consideration of a recall of product should be given due to the critical findings observed. Using QRM principles, National supply situation and clinical requirements should be taken into account when making this decision.

Prohibition of supply
The site has been issued a statement of non compliance and should not be named on any marketing authorisations whilst this statement remains in place.

Suspension or voiding of CEP (action to be taken by EDQM)
Suspension of CEP 2005-258 (Enoxaparin sodium).