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Page_Header_ Page_Header_ 42 BioPharm International eBook December 2019 Regulatory Sourcebook Resources tashatuvango - Access key regulatory and standard setting resources, guidance documents, and guidelines by clicking on the title of the document. Resources, Guidelines, and Guidance Documents T he regulatory nature of the bio/ pharmaceutical industry requires close adherence to regulations, good manufacturing practices, and guidelines. The websites of regula- tory authorities provide information to assist drug development and manu- facturing organizations in navigating the regulatory process. This section lists information sources to key topics; click the appropriate link to access the online information. The following pages list key guid- ance documents f rom FDA, the European Medicines Agency (EMA), t h e Wo r l d H e a l t h O r g a n i z a t i on ( W H O ) , a n d t h e I n t e r n a t i o n a l Council for Harmonisation (ICH)*. US FOOD AND DRUG ADMINISTRATION RESOURCES • FDA Human Drugs • FDA Animal/Veterinary Drugs • FDA Vaccines, Blood, and Biologics • FDA Cellular & Gene Therapy Products • FDA Compliance Actions and Activities • FDA Development & Approval Process • FDA Drug Shortages • FDA Guidance Documents • FDA New Drug Approvals • FDA Regulatory Science • FDA Rules and Regulations • FDA Warning Letters US REGULATIONS • Code of Federal Regulations, Title 21, Food and Drugs • Federal Register Notices Pertaining to Drugs FDA GUIDANCE DOCUMENTS • Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF) • Analytical Procedures and Methods Validation for Drugs and Biologics (PDF) • Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, Draft Guidance (PDF) • CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (PDF) • Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry, Draft Guidance (PDF) • Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF) • Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF) • Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF) • Elemental Impurities in Drug Products Guidance for Industry (PDF) • Guidance for Industry - Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (PDF) • Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry, Draft Guidance • INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF) • PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF) • Postapproval Changes to Drug Substances Guidance for Industry, Draft Guidance (PDF) • Preparation of Investigational New Drug Products (Human and Animal) (PDF) • Process Validation: General Principles and Practices (PDF) • Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF) • Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF) • Using the Inactive Ingredient Database Guidance for Industry, Draft Guidance

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