ICH Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines to ensure the quality, safety, and efficacy of pharmaceutical products. These guidelines cover various aspects of drug development and regulation, including:

Q1: Stability Testing of New Drug Substances and Products
Q2: Validation of Analytical Procedures
Q3: Impurities in New Drug Substances
Q4: Pharmacopoeias
Q5: Quality of Biotechnological Products
Q6: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q8: Pharmaceutical Development
Q9: Quality Risk Management
Q10: Pharmaceutical Quality System
Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

Q13: Continuous Manufacturing of Drug Substances and Drug Products

These guidelines help ensure that pharmaceutical products meet international standards and can be marketed globally. Always refer to the latest versions and regional regulatory requirements for specific guidance.

For more details on ICH guidelines refer to the link below


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