Course description
It is common practice in the Pharmaceutical Industry to handle multiple drug products in one manufacturing site. For contract manufacturing organisations or generic companies, it might be required to work with several hundreds of APIs in one production facility. As cross-contamination cannot be completely excluded, it is required to reduce the risk to a level which is considered acceptable from a patient perspective. The EMA Shared Facilities Guideline requires calculation of tolerable cross-contamination levels based on the API-specific PDE (= Permitted Daily Exposure) values.
The approach set by the Shared Facilities Guideline has been further detailed in the PIC/S Aide.memoire PI 043-1 which provides a questionnaire for the GMP auditor. Each company running a multi-purpose plant has to implement effective risk management processes to set specific limits based on toxicological properties of each API.
The risk assessment should be extended from cleaning validation of single instruments to the entire manufacturing chain of a drug product. This manufacturing chain extends from material entry to dispatch of the medicinal product to the customer. A comprehensive risk assessment of all possible cross-contamination routes is required for shared facilities to identify risk mitigation measures which might have to be implemented.
The training will share approaches how systematic risk management of cross-contamination risks can be performed and implemented in the QA system.
