Regulatory Pharma Blogs
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 1. Introduction Bracketing and Matrixing Designs Bracketing: The stability of drug substances and products is essential for ensuring their quality, safety, and efficacy over time. Stability testing helps determine the shelf life, appropriate storage conditions, and expiration dates of pharmaceutical products. Bracketing …
Stability Testing: Photostability Testing of New Drug Substances and Products 1. General Overview Photostability Testing The International Council for Harmonisation (ICH) Harmonized Tripartite Guideline for the stability testing of new drug substances and products (referred to as the Parent Guideline) outlines the importance of light testing as a critical aspect of stress testing. This document …
Stability Testing for New Dosage Forms: A Comprehensive Overview New Dosage Forms: The International Conference on Harmonisation (ICH) established the Harmonised Tripartite Guideline on Stability Testing of New Drugs and Products to ensure the stability and quality of pharmaceutical products. This guideline plays a vital role in the pharmaceutical industry, providing regulatory clarity on how new …
Stability Testing of New Drug Substances and Products 1. Introduction Stability Testing 1.1 Objectives of the Guideline Stability Testing This guideline is an updated version of the ICH Q1A (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guideline, which defines the essential stability data package required for new drug substances and …
Understanding Out of Specification (OOS) Results in Pharmaceutical Quality Control Out of Specification: In the pharmaceutical industry, maintaining consistent quality is paramount, not just to meet regulatory standards, but also to ensure patient safety. One critical element in ensuring this consistency is the concept of “Out of Specification” (OOS) results, which signifies a test result …
Understanding Corrective and Preventive Action (CAPA) in the Pharmaceutical Industry Corrective and Preventive Action (CAPA) is an integral part of quality management in the pharmaceutical industry. It is a systematic approach used to identify, address, and eliminate problems that could compromise the quality of pharmaceutical products and services. CAPA is crucial for ensuring that the …
The Pharmaceutical Quality System (PQS) under EU GMP Guidelines Pharmaceutical Quality System: The European Union (EU) Good Manufacturing Practice (GMP) guidelines for medicinal products for human and veterinary use emphasize the importance of maintaining a robust pharmaceutical quality system to ensure the safety, efficacy, and quality of medicines. Chapter 1 of the EU GMP guidelines …
Self-Inspection Under EU GMP Guidelines: A Comprehensive Overview Self-Inspection Under EU GMP Guidelines: The pharmaceutical industry is governed by strict standards that ensure the safety, quality, and efficacy of medicinal products. One of the core components of these standards is the Good Manufacturing Practice (GMP), which sets out the best practices for manufacturing, quality control, …
SCHEDULE M – GMP – PART 1: GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS “Schedule M” outlines the guidelines set by the World Health Organization (WHO) for pharmaceutical product manufacturing, ensuring the quality and safety of both the products and their production processes. GENERAL REQUIREMENTS: SCHEDULE M Location and Surroundings: The pharmaceutical manufacturing facility must …
Revised and Expanded Version of Schedule M-II on GMP Guidelines for Cosmetic Manufacturing Introduction to Schedule M-II: Good Manufacturing Practices (GMP) for Cosmetic Manufacturing Premises and Equipment Cosmetic Manufacturing: In order to ensure the safety, quality, and consistency of cosmetic products, the manufacturing processes must adhere to stringent guidelines. One of the key regulatory frameworks …