【讨论】GMP Non Compliance Reports - Update in EMA Database

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The EMA Database EudraGMDP is a major achievement for GMP and GDP compliance information. Since parts of the data are now publicly accessible, it makes it easier to get important information relevant for supplier qualification. In the past, it was difficult to discover if a manufacturing site had been identified out of GMP compliance. Now, such information is publicly available.
In the following, we have listed the 2014 updates of GMP Non-Compliances:
We already reported in our GMP News 85 Company listed with GMP-Non Compliance Statements in the New EMA Databaseabout the Non-Compliance Reports for Smruthi in India (Taluka Mohol). In total, 29 GMP deviations have been identifed at this manufacturing site. As a consequence, the APIs concerned can't be used any longer for the manufacture of medicinal products in Europe.
On 10th of February 2014, the Spanish Authority issued a GMP Non-Compliance Report for Industrias GMB, S.A. in Barcelona. Here again, the site is involved with the manufacture of APIs. According to the report, a recall of all APIs (other than beta-lactam antibiotics) micronized at the Industrias GMB, S.A. site has already been started. In addition, the authority issued "a prohibition of the supply of the pharmaceutical active ingredients micronizated by this manufacturer and a suspension of the activity of micronisation and closure of the area destined to the micronisation and primary and secondary packaging of micronisated products". The major GMP deviation identified was: "Inappropiate measures of confinement of the rooms destined to the micronisation and conditioning of beta-lactam antibiotics wich implies a risk of cross contamination with traces of beta-lactam antibiotics of other pharmaceutical active substances which are micronized by this manufacturer".
Also the Czech Republic Authoritiy has issued a GMP Non Compliance Report. The manufacturer Vakos XT a.s. in Prague has been found out of GMP Compliance. According to the authority: "The pharmaceutical quality system in the company is dysfunctional and VAKOS XT, a.s. does not meet GMP requirements. VAKOS XT, a.s. produced and exported to the Slovak Republic sterile medicinal product MULTIPEN HD. VAKOS XT, a.s. is not authorised to manufacture and release sterile medicinal products". As a consequence, the manufacturing authorisation has been suspended.
The French Health Products Safety Agency has issued an alarming GMP Non Compliance Report for Somet in Monaco. The company produces a wide range of APIs. The deviations identified at the manufacturing facility are very serious. According to the Non Compliance Report: "Overall, 31 deficiencies were observed, including 2 Critical and 12 Major deficiencies : [Critical] The manufacturing and cleaning operations during and between the campaigns of 15 APIs, whose 2 are used in injectable dosage forms and one is an ectoparasiticide (Fipronil), are not traceable. Many records are missing..." As a consequence the authority has withdrawn 9 GMP Certificates of the company but also recommends to other National Competent Authorities to consider recall of product in their territory due to the risk of cross-contamination and the lack of manufacturing traceability.
SCM Pharma Limited in the UK received a GMP Non-Compliance Statement due to an MHRA Inspection. The products concerned are both sterile and non sterile products. According to the Inspections report: " A critical deficiency was cited regarding potential product cross contamination, this deficiency was divided into two sections : A. Potential chemical contamination, it was found that the company were manufacturing a potent cytotoxic (Amsacrine) product in the non-potent suite. Processes intended to contain the product had failed and cleaning process and verification were weak with contamination of general manufacturing areas seen. B. Potential microbial contamination. There were contaminated process media simulations that were not adequately investigated and root cause explained and mitigated. VHP sanitisation of the filling isolator inadequately controlled and validated and weaknesses in the environmental monitoring program.
The Swedish Agency MPA has issued a GMP Non-Compliance Statement for Seikagaku Corporation Takahagi plant in Japan. During the inspection 1 critical, 1 major and 24 other deficiencies were found. The critical deficiency concerns systematic rewriting/manipulation of documents, including QC raw data. The company has not been able to provide acceptable investigations and explanations to the differences seen in official and non-official versions of the same documents.