GMP-relevant sind die Kategorien Pharmaceutical Quality/CMC und Pharmaceutical Quality CGMP sowie Pharmaceutical Quality/Microbiology.
Die Kategorien beinhalten folgende Dokumente:
Pharmaceutical Quality CGMP
- PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
Pharmaceutical Quality/CMC
- ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
- Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
- Chemistry Manufacturing and Controls Considerations for Individualize Antisense Oligonucleotide (ASO) Therapies
- Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations
- ICH Q12, General Considerations for FDA Implementation
- Inspection of Injectable Products for Visible Particulates
- Quality Considerations for Topical Ophthalmic Drug Products
- Quality and Stability Testing of Drug Substances and Drug Products for NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
- Risk Management Plans to Mitigate the Potential for Drug Shortages
- Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics
- The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
Pharmaceutical Quality/Microbiology
- Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing
- Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics
Die fett markierten Dokumente fanden sich bereits im letzten Jahr auf der Liste. Die vollständige CDER-Liste finden Sie hier.
Quelle:
FDA: Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2020