The capacity to obtain high quality active ingredients in the crystalline form is crucial to ensure the technological and performance profile of the finished medicinal product. We discussed with the experts the main features of a good crystallisation process
The new EU guideline 2015/C 95/02 calls pharma companies to run by March 2016 a detailed analysis of the impact and risks expected by the use of the excipients in product development and manufacturing. We discussed the key points of the guideline with representatives of both the suppliers and the pharmaceutical industry
The clear room validation is a critical point in the global validation of the production process for sterile drugs. Many factors should be considered, together with accurate risk analysis and process planning. Future might see different approaches to clean room validation
