Lenovo Way Forward

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Anto Noval

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The European Commission Health and Consumers Directorate – General has published draft “GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” for public consultation. Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.

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ICH stability guidances provide guidance for new drug substances and drug products .CDER now wishes to apply these recommendations to ANDAs. Specific recommendations were given in FDA “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products. Recently FDA issued “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers. Drug Regulations has prepared a presentation on ANDA stability requirements.

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FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. This presentation - Part IV in the series- deals with the concepts of Design Space, Design of experiments and Models. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.

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Lenovo Way Forward

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