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