In der GMP-relevanten Kategorie  „Pharmaceutical Quality/Manufacturing Standards (CGMP)“ sind folgende Dokumente gelistet:

• CDER’s Program for the Recognition of Voluntary Consensus Standards
• Drug Master Files; Revised Draft
• Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
• In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
• Transdermal and Topical Delivery Systems-Product Development and Quality Considerations
• Quality Considerations for Continuous Manufacturing (CM)
• Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software
• Using the Inactive Ingredient Database
• Risk Management Plans for Drug Manufacturers
• Quality Considerations for Topical Ophthalmic Drug Products
• Inspection of Injectable Products for Visible Particulates
• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics
• Stability Considerations for NDAs, ANDAs and BLAs
• ANDAs: Stability Testing of Drug Substances and Products Questions and Answers

In der Kategorie „Pharmaceutical Quality/Microbiology“ findet sich, wie bereits im letzten Jahr, die

• Microbiological Considerations for Non-Sterile Drug Products

Diese und alle weiteren Dokumente finden Sie direkt in der Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2019.

Quelle:

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