Changes in 21 CFR Part 11 Subpart C, Electronic SignaturesChanges in 21 CFR (Code of Federal Regulations) Part 11 Subpart C Electronic Signatures § 11.100 General requirements.
Shutdown of European Pharmacopoeia 10th EditionEuropean Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. all previous versions are no longer been accessible.
QUALITY RISK MANAGEMENT ICH Q9 (R1)Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ProductsDraft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
New paragraph on control of N-nitrosamines, Ph. Eur. revised General Monograph 2034 and 2619Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of a new paragraph on control of N-nitrosamines