Short Notes on ICH Q8 (R2) Guidelines for pharmaceutical development.
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GUIDELINES FOR PHARMACEUTICAL DEVELOPMENT - Q8(R2) :
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
This Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk
management to the development of a product and its manufacturing process.
The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.