Nature of non-compliance : A prior inspection in March 2015 identified several serious Major deficiencies in the operation of the Pharmaceutical Quality System. These included systems to ensure Data integrity, Deviations and CAPA management, Change Controls, PQRs and Self-Inspection. A November 2015 re-inspection was carried out to assess the remediation plan from the company. There was a lack of evidence to demonstrate the effectiveness of resultant CAPAs taken and a lack of interim assurances to ensure that the on-going operations remain in compliance with GMP, including failures to carry out effective investigations. The November inspection identified a critical deficiency relating to systems to ensure Data Integrity in the following respects:
o Evidence of destruction of multiple parts of records of prime data
o Overall Data Integrity management and oversight
o Investigations into Missing and deleted data within the laboratory incomplete
o Procedures controlling Data Integrity within the laboratory not in place
Withdrawal, of current valid GMP certificate No. UK GMP 19826 Insp GMP 19826/39398-0003
Withdrawal of previous GMP Certificate No: UK GMP 19826 Insp GMP 19826/39398-0003
吊销现有GMP证书
Requested Variation of the marketing authorisation(s)
No further MA should be approved naming the site as manufacturer. Current pending MA applications should be held or refusal to grant stated whilst this statement of non-compliance remains in force.
Recall of batches already released
There is no evidence of defective product currently on the market. Recall of products is not considered necessary.
没有证据证明目前有缺陷产品目前在市场上销售。可以不必考虑召回产品。
Prohibition of supply
No further batches of medicinal products considered non-critical to public health to be supplied to the market whilst this statement on non-compliance remains in force