9-11 April 2024
In the EudraGMDP database, results of European inspectors are published in so-called Non-Compliance Reports. In the period October-November 2022, there were two reports in the area of GMP, both of which were issued due to cross contamination.
In the first case, an Indian manufacturer of non-sterile active ingredients was affected, which had been inspected by the French authority. In total, there were 24 deviations, two of which were classified as critical and three as serious. Overall, the lack of a QA overview as well as the understanding of the basic (GMP) requirements is criticised. Specifically, the lack of cross contamination control is criticised, which the authority has classified as critical due to the patient risk it poses. The manufacturer produces highly active substances in non-dedicated facilities with poor maintenance and cleaning performance. Some of the active ingredients produced are later used to manufacture sterile/parenteral medicines. Specifically, a 10.5 m2 area and its equipment were found to be in an unacceptable state of maintenance and cleaning and were designed inappropriately for their purpose. Deficiencies in supplier qualification and cleaning validation were judged to be serious.
Source: EudraGMDP Database (Inspection Date: 7 September 2022; Report Number: 22MPP058NCR, Reference Number: 153797)*
In the second case, an Italian manufacturer was inspected by the Italian authority.
The manufacturer exclusively produces the active ingredient hyaluronidase, an enzyme derived from bovine testicles. The active ingredient obtained in this way is used in-house for the production of sterile injectables.
The risk of cross contamination between the activities before and after virus inactivation due to a lack of an suitable HVAC system was criticised. In addition, the same equipment was used for both manufacturing steps, partly in non-closed systems. Cleaning was also criticised, as the use of 1M NaOH for inactivation had not been validated. Furthermore, there was only one washroom for cleaning the equipment before and after inactivation.
Source: EudraGMDP Database (Inspection Date: 1 September 2022; Report Number: IT/NCR/API/02/2022, Reference Number: 152622)*
* To find the respective report, please click on "Non-Compliance Reports" in the database menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.