News about GMP/cGMP


FDA: CDER List for Planned Guidance Documents in 2019

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to release in 2019. A total of 93 planned guidance documents have been set out which are categorised in 15 different themes.

In the GMP relevant category „Pharmaceutical Quality/Manufacturing Standards (CGMP)“ the following titles are listed:

  • 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

The category of “Pharmaceutical Quality/Microbiology” lists – as in the previous year –

  • Microbiological  Considerations  for  Non-Sterile   Drug  Products

This takes you directly to the "Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2019".


FDA: What's new