New GMP Non-Compliance Reports in EMA Database

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The European Medicines Agency (EMA) has established a database which contains GMP and GDP compliance information. This database is called EudraGMDP. For some time now the EMA has also been publishing GMP and GDP Non-Compliance Reports. Some reports cover API manufacturing sites, others cover manufacturing sites for medicinal products. Products from the concerned manufacturing sites should not be used until the GMP compliance is guaranteed again. If a GDP Non-Compliance report has been issued the organisation is no longer allowed to distribute medicinal products or APIs.

The UK Medicines authority MHRA has issed a GMP Non-Compliance Report for WOCKHARDT LIMITED in AURANGABAD, India. A number of Wockhardt operations have already been under scrutiny by US FDA. The current entry in the EU database refers to a number of critical and major findings.  "A critical deficiency was cited with regard to data integrity of GMP records, entries were seen to be made when personnel were not present on site, documentation was seen that was not completed contemporaneously despite appearing to be completed in this manner. A second critical deficiency was cited regarding potential product contamination. This included the use of inappropriate materials close to product, e.g. asbestos coated PTFE seals for centrifuge manways." In addition major deficiencies e.g. on facility, maintenance, design and qualification have been identified. The MHRA states "There are no current GMP certificates in place for this API facility. A restricted GMP certificate will be issued to permit continued testing of products considered to be medically critical, as determined by the national competent authority. National competent authorities should request marketing authorisation holders to conduct a risk assessment to evaluate the risk to product quality and patients from the issues identified".

Just recently the MHRA has published a GMP Non-Compliance Report for MOORFIELDS PHARMACEUTICALS in London (UK) which contains a number of Investigational Medicinal Products (IMPs). The report states: "Serious deficiencies related to sterility assurance, sterilisation processes and the Pharmaceutical Quality System have been identified at Moorfields Pharmaceuticals. Concerns implicate all aspects of aseptically prepared and terminally sterilised products. Failures and non-compliances were identified with the approach to qualification and the routine controls of sterilisation. Poor aseptic practices were noted with manufacturing processes. Grade A HEPA filter integrity failures have been noted for some areas. Microbiological environmental monitoring and media simulation programmes were deficient. Media simulation failures have been identified. Serious deficiencies were noted with the Pharmaceutical Quality System. Company Corrective and Preventative actions and remediation, to date, have failed to adequately address all deficiencies and non-compliances. There is currently no evidence of non-sterile product on the market. Most unauthorised medicinal products are small volume short shelf life, and not subject to sterility testing. A supervisory risk assessment has been circulated via rapid alert. "

The Italian Agency AIFA has issued a GMP Non-Compliance Report for SIMS Società Italiana Medicinali Scandicci srl located in Reggello, Italy. According to AIFA the inspection at the API manufacturer was unannounced in collaboration with Italian police authorities and Italian custom authorities. AIFA found two unauthorized, not-GMP storage areas (declared as office area) among others used for storage of imported materials from China. Also a not compliant GMP repackaging station was found.

In Malta the competent authority found a wholesale distributor who did not comply with GDP requirements. Moreover, the company was made responsible for trading in falsified medicinal products (not purchased from legal supply chain). The wholesale dealer's license was revoked.

Source: EudraGMDP Database