ICH Quality (Q) Guidelines and Their Relevance to Pharmaceutical Manufacturing

In this article we discuss on ICH Quality (Q) Guidelines and their relevance to different phases of drug development and manufacturing.

ICH Q1A(R2) – Stability Testing of New Drug Substances and Products

This guideline provides recommendations on the stability testing of new drug substances and products, including the design of stability studies, testing conditions, and data analysis. It is relevant to the preclinical and clinical development phases as well as post-approval.

ICH Q1B – Photostability Testing of New Drug Substances and Products

This guideline provides recommendations on the photostability testing of new drug substances and products, including the design of photostability studies, testing conditions, and data analysis. It is relevant to the preclinical and clinical development phases as well as post-approval.

ICH Q2(R1) – Validation of Analytical Procedures: Text and Methodology

This guideline provides recommendations on the validation of analytical procedures used in the development and quality control of drugs. It is relevant to all phases of drug development.

ICH Q3A(R2) – Impurities in New Drug Substances

This guideline provides recommendations on the identification, qualification, and control of impurities in new drug substances. It is relevant to the preclinical and clinical development phases as well as post-approval.

ICH Q3B(R2) – Impurities in New Drug Products

This guideline provides recommendations on the identification, qualification, and control of impurities in new drug products. It is relevant to the preclinical and clinical development phases as well as post-approval.

ICH Q5C – Quality of Biotechnological Products | Stability Testing for Biotechnological/ Biological Products

This guideline provides recommendations on stability testing for biotechnological/biological products, including design considerations, testing conditions, data analysis, and interpretation. It is relevant to all phases of drug development.

ICH Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products

This guideline provides recommendations on the establishment of specifications for new drug substances and products, including test procedures and acceptance criteria. It is relevant to all phases of drug development.

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

This guideline provides recommendations on good manufacturing practices for active pharmaceutical ingredients (APIs). It is relevant to the manufacturing phase of drug development.

ICH Q8(R2) – Pharmaceutical Development

This guideline provides recommendations on pharmaceutical development, including the principles and concepts of quality by design (QbD), risk management, and lifecycle management. It is relevant to all phases of drug development.

ICH Q9 – Quality Risk Management

This guideline provides recommendations on quality risk management, including the principles and concepts of risk assessment, risk control, and risk communication. It is relevant to all phases of drug development.

ICH Q10 Pharmaceutical Quality System

This guideline provides recommendations on the establishment of a pharmaceutical quality system (PQS), including the principles and concepts of quality management, continual improvement, and performance monitoring. It is relevant to all phases of drug development.

ICH Q11 – Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

This guideline provides recommendations on the development and manufacture of drug substances, including the principles and concepts of process validation, process characterization, and comparability studies. It is relevant to all phases of drug development.

Read also:

Resource Person: Ershad Moradi