Blog
Analytical Method Validation: ICH Q2(R1) Requirements and How to Apply Them
Analytical method validation is one of the most consistently cited gaps in FDA inspections of pharmaceutical and biotech manufacturers. It
Cleaning Validation: FDA and EU GMP Requirements for Equipment and Facilities
Cleaning validation consistently appears among the most frequently cited areas in FDA Form 483 observations and warning letters for pharmaceutical
Process Validation: FDA’s Three-Stage Approach – Stages 1, 2, and 3 Explained
The FDA’s 2011 guidance document “Process Validation: General Principles and Practices” replaced the prior approach of discrete validation batches with
AS9100 Quality Management for Aerospace: Requirements and Implementation Guide
AS9100 is the quality management system standard for aviation, space, and defense organizations. Published by the International Aerospace Quality Group
EU Annex 1 Sterile Manufacturing: 2022 Revision Requirements for Quality Teams
The 2022 revision of EU GMP Annex 1 is the most substantial update to sterile pharmaceutical manufacturing guidance since the
ICH E6(R3) Good Clinical Practice: Key Changes and QMS Implications for Sponsors and CROs
ICH E6(R3), the revised Good Clinical Practice guideline, reached Step 4 finalization on January 6, 2025, ending more than six