News about GMP/cGMP


FDA: CDER list of all guidelines planned for 2020

This year's list of guidelines to be published by the CDER (Center for Drug Evaluation and Research) comprises 14 categories with a total of 89 documents. 

The categories relevant to GMP are Pharmaceutical Quality/CMC and Pharmaceutical Quality CGMP as well as Pharmaceutical Quality/Microbiology.

The categories include the following documents:

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

The documents shown in bold type were already on last year's list. The complete CDER list can be found here.


FDA: Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2020