GMP Insiders - Your trusted source for GMP compliance!

Category: News

If you don’t find what you are looking for, try using a different term or contact us.

Revised EDQM guideline explains how to read a CEP, covering CEP 2.0, site details, impurities, and regulatory declarations for better...
USP–NF PF 51(3) draft introduces new PAT, content uniformity, parenteral leachables, and CBD standards, enhancing GMP control and regulatory alignment....
Discover the 2025 USP update on elemental impurities: key changes, harmonization across pharmacopeias, and compliance insights....
ICH Q1 draft released: a unified guideline for stability testing with new content on lifecycle, in-use studies, modelling, and advanced...
Ph. Eur. adds rFC to BET (2.6.14) and updates pyrogen testing (5.1.13) to support sustainable, animal-free methods in line with...
FDA warns Yangzhou Sion for CGMP violations, citing failures in component testing, QC oversight, and data integrity. CAPA plan and...
The FDA has issued a warning letter to Aspen SA Sterile Operations for serious CGMP violations, including failures in lab...
FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its...
FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key...
Discover the key updates in USP–NF PF 51(2), including revisions to chromatography, analytical instrument qualification, microbial contamination control, solubility measurements,...

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News