News about GMP/cGMP


FDA: CDER agenda of all guidance documents planned for 2021

FDA: CDER agenda of all guidance documents planned for 2021

This year's Center for Drug Evaluation and Research (CDER) list of guidance documents scheduled for publication includes 18 categories with a total of 105 documents.

These are four more categories and 16 more documents than last year. Documents that were already on last year's list are highlighted in bold below. They clearly represent the majority. Here, too, the delays in processing caused by the Corona pandemic can be seen.

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

Pharmaceutical Quality CGMP

  • PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
  • Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

Pharmaceutical Quality/CMC

  • ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
  • 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
  • Benefit-Risk Considerations for Product Quality Assessments

Pharmaceutical Quality/Microbiology

  • Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing

FDA: CDER Guidance Agenda New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021