CMC GUIDANCES ----------------------------------------------------------------------------------------------- CPMP Quality Working Party Guidance Chemistry of the New Active Substance DRAFT Sterilisation Methods Selection Development Pharmaceutics Declaration of Storage Conditions for Product Particulars Dry Powder Inhalers Explanatory Note on Residual Solvents to Marketed Products European Drug Master File Procedure for Active Substances Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products In-Use Stability Testing of Non-Sterile Human Medicinal Products Investigation of Bioavailability and Bioequivalence DRAFT Manufacture of the Finished Dosage Form Maximum Shelf-Life for Sterile Products after First Opening or following Reconstitution Parametric Release Process Validation DRAFT Quality of Modified Release Products Reduced Stability Testing Plan Requirements for Pharmaceutical Documentation for Metered Dose Inhalers Requirements for Active Substances in Part II of the Dossier Revision of the Note for Guidance on Radiopharmaceuticals Stability Testing for a Type II Variation to a Marketing Authorisation Stability Testing of existing Active Substances and Related Finished Products In-Use Stability Testing of Human Medicinal Products Community Basic Format for Manufacturing Authorisation Explanatory Notes Chemical reference substance Search Medicinal Products for Human Use Guidelines Packaging Basics Packaging Guiding Principles Quality and Biotechnology Guidelines
		GOOD MANUFACTURING PRACTICES ----------------------------------------------------------------------------------------------- European Community Good Manufacturing Practices of Pharmaceuticals