21 CFR
Changes in 21 CFR Part 11 Subpart C, Electronic Signatures
Update on recent changes in 21 CFR (Code of Federal Regulations) On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic…
News and Updates
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News and Updates
Shutdown of European Pharmacopoeia 10th Edition
European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. all previous versions are no longer been accessible.
News and Updates
ICH Q9(R1) Quality Risk Management: Summary & Changes
Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Manufacturing and Packaging
FDA Dosage & Administration Labeling Guidance — Docket No.
Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
News and Updates
New paragraph on control of N-nitrosamines, Ph. Eur. revised General Monograph 2034 and 2619
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of a new paragraph on control of N-nitrosamines
Manufacturing and Packaging
WHO TRS 1044 (2022): 56th Report Annexes & PDF
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
News and Updates
Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1
EDQM revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders
General
Multiple Endpoints in Clinical Trials Guidance for Industry
GUIDANCE DOCUMENT Multiple Endpoints in Clinical Trials Guidance for Industry OCTOBER 2022 Docket Number: FDA-2016-D-4460 Issued by: Center for Biologics…
Manufacturing and Packaging
Size, Shape, and other physical Attributes of Generic Tablets and capsules
US FDA has revised the guideline for Size, Shape, and other physical Attributes of Generic Tablets and capsules. USFDA Guidelines