The 46-pages guideline:
The introductory Part I of the guideline addresses CM concepts, the scientific approach, and regulatory considerations, such as manufacturing processes, control strategies, batch sizes, product stability, process validation, or the pharmaceutical quality system. Included are sensible recommendations regarding regulatory expectations that provide manufacturers with a flexible approach.
Part II includes five annexes that offer concise explanations and practical examples. These include flowcharts with manufacturing processes and also various examples of how to handle process disturbances:
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