Bracketing and Matrixing Designs for Stability Testing
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 1. Introduction Bracketing and Matrixing Designs Bracketing:…
Regulatory Pharma Blogs
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 1. Introduction Bracketing and Matrixing Designs Bracketing:…
Stability Testing: Photostability Testing of New Drug Substances and Products 1. General Overview Photostability Testing The International Council for Harmonisation…
Stability Testing for New Dosage Forms: A Comprehensive Overview New Dosage Forms: The International Conference on Harmonisation (ICH) established the…
Stability Testing of New Drug Substances and Products 1. Introduction Stability Testing 1.1 Objectives of the Guideline Stability Testing This…
Understanding Out of Specification (OOS) Results in Pharmaceutical Quality Control Out of Specification: In the pharmaceutical industry, maintaining consistent quality…
Understanding Corrective and Preventive Action (CAPA) in the Pharmaceutical Industry Corrective and Preventive Action (CAPA) is an integral part of…
The Pharmaceutical Quality System (PQS) under EU GMP Guidelines Pharmaceutical Quality System: The European Union (EU) Good Manufacturing Practice (GMP)…
Self-Inspection Under EU GMP Guidelines: A Comprehensive Overview Self-Inspection Under EU GMP Guidelines: The pharmaceutical industry is governed by strict…
SCHEDULE M – GMP – PART 1: GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS “Schedule M” outlines the guidelines set…
Revised and Expanded Version of Schedule M-II on GMP Guidelines for Cosmetic Manufacturing Introduction to Schedule M-II: Good Manufacturing Practices…