EMA and the European Directorate for the Quality of Medicines & Healthcare (EDQM) have reviewed EMA’s sampling and testing programme for centrally authorised medicines on the EU/EEA market, which has been organised yearly since 1998.
The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s control methods for their medicines. In a small number of cases, the tested samples were not compliant with the authorised quality specifications for the medicine and required other regulatory actions such as re-testing, inspections, recalls or suspension of supply. These are some of the key findings in a report summarising the sampling and testing activities and main achievements over the past 20 years.
The programme is an important part of the supervision of the quality of centrally authorised products (CAPs) for human and veterinary use in all parts of the distribution chain. The tests are aimed at verifying the compliance of medicines with their authorised specifications and ensuring that the manufacturer’s control methods are satisfactory.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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