FDA Plans for new (GMP) Guidance in 2021 - CDER provides Information

Recommendation

7/8 September 2022
Vienna, Austria

Quality Culture
People Empowerment in GMP

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.

On the subject of GMP, guidelines that are planned and/or need to be revised can be found under various categories, most of them under "Pharmaceutical Quality" but also under "Procedures". The following is a selection of the planned / to be revised guidelines with direct or indirect reference to GMP:

• PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft 
• Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination 
• 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 
• Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing 
• Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers

Visit the FDA website for the complete  Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2021.