European Competent Authorities publish GMP Non-Compliance Statements

The German Competent Authority "Landesamt für soziale Dienste Schleswig-Holstein" has issued a GMP Non-Compliance Statement for an Indian API manufacturer which has been recently published on the EMA homepage (Artemis Biotech, a Division of Themis Medicare Limited Hyderabad)

The text looks into the causes which led to the Non-Compliance Statement. The manufacturer concerned is an Indian manufacturer whose production of Simvastatin as an API has been inspected. Issues regarding a lack of QA oversight have been mainly identified. In total, 35 deficiencies were discovered by the authority in the course of the inspection. Among them, 5 were classified as "major". According to the "Landesamt", the APIs manufactured present a potential risk for humans and animals.  

In detail, the critics address:

  • The use of an Enterprise Ressource Planning Systems (ERPS) also hosting GMP-relevant data but with no connection to the QM system. This deficiency focusses on a missing QA oversight.
  • Repacking operations were executed without any documentation and QA approval.
  • The issuance of labels for raw materials and APIs was insufficient and insufficiently controlled.
  • In the laboratory, basic requirements with regard to data integrity were violated -  like for example a manual integration without justification and QA oversight.
  • The inspectors found the company's approach on the validation of computerised systems not compliant with the usual requirements.

The part "Action taken/proposed by the NCA (National Competent  Authorities)" is particularly severe for the Indian manufacturer:

  • An assessment whether a product recall is necessary (but with regard to potential risks of shortage). Moreover, an assessment should be performed by the National Competent Authorities to retest all imported batches.
  • The further supply of the product should be prohibited.
  • Suspending i.e. voiding of the corresponding CEP is recommended. The decision has to be taken by the EDQM.
  • The supplier should not be approved in new applications for a marketing authorisation. The National Competent Authorities concerned should evaluate whether the supplier should be removed from current marketing authorisations.

An additional comment points out that the manufacturer also produces an antibiotic for the French market. This API was not within the scope of the inspection...

Besides, the Spanish authority has also published two GMP Non-Compliance Statements: one for a Chinese API manufacturer, the other one for a Spanish medicinal products manufacturer.

The CEP of the Chinese company (JINAN JINDA PHARMACEUTICAL CHEMI. CO LTD in Shandong) was withdrawn in 2015 already. It turned out the CAPA measures promised after the inspection hadn't been implemented satisfyingly. In total, the Spanish authority identified 2 critical and 8 major deficiencies, whereby the critical deviations concerned the safety and control of raw data as well as OOS assessments. Among other things, the main deficiencies concerned process and cleaning validation.

Regarding the Spanish manufacturer of liquids (ALCOR, S.L. in Guadalajara), the lack of resources, facilities, personnel and materials has been particularly criticised. The CAPA proposed were considered not appropriate by the authority who sees the accumulation of tasks and responsibilities in some personnel as a risk to quality.

Last but not least, the British Authority (MHRA) also wrote a GMP Non-Compliance Statement. Here, an Indian manufacturing site of Hospira Healthcare that manufactures sterile medicinal products (lyophilisates, small-volume liquids and aseptically filled powders) was concerned. For the MHRA, the conclusion to the many deficiencies discovered  there (e.g. inappropriate room segregation and classification, deviating media fills without any root cause finding,  etc.) can be reduced to one causal point: a lack of scientific knowledge.

You can find all the statements described above on the EMA website.

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