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Workshop: Manufacture and Registration of sterile medicines in Kenya

Pharmaceutical Inspectors from Regulatory Authorities are responsible for the qualification of pharmaceutical manufacturers. EAC inspectors have to audit pharmaceutical manufacturers in their home countries and worldwide in order to check GMP compliance. With regard to regulatory affairs the EAC has furthermore taken up the huge task of implementing a common regulatory system.

Workshop

A one week workshop for pharmacists working in regulatory authorities and the pharmaceutical industry focused on the special features of sterile medicinal products. Key topics were hygiene, equipment and premises, microbiological testing and other quality control tests as well as procedures to ensure that products are sterile and pyrogen-free.

Small tutor groups prepared checklists and questionnaires as useful tools for upcoming audits. As soon as a regulatory authority has certified a manufacturer, this manufacturer may apply for marketing authorisations for a specific product. The training participants worked out the specialities for sterile products. In working sessions they assessed registration dossiers for sterile pharmaceutical products.

The workshop helped to establish a common view on GMP for sterile products and ways to assess registration dossiers for sterile products. Inspectors and Regulatory staff from medicines regulatory authorities were assured of their important role in securing access to safe and efficacious medicines of good quality.

All participants received a training manual with the lectures, tutorials, results from the group work as well as information material such as laws and guidelines for further perusal and internal training.