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Lab scale manufacturing of drug substances and drug products and solutions, manufacture of scientific provides for clinical reports, scaling up to professional batch sizing, professional product.• Defines requirements and processes for all supplies and methods of manufacture and HandleAns: The EMA draft guideline states “a minimum of a fe
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IMPs are unaffected because the obligations of producing-authorisation holders In cases like this are laid down in Directive 2005/28/EC, which does not contain corresponding needs for active substances. Furthermore, This is often built clear during the introduction to section II in the GMP guideline.The development from the product specification fi