ICH Guideline Q1 to Q14

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What is ICH Guidelines :

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects.

What are the purpose of ICH Guidelines :

The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for
product registration.

ICH Q1 to Q14

Q1A Stability testing of  new drug substances and products
Q1B Stability testing: photo stability testing of new drug substances and products
Q1C Stability testing for new dosage forms
Q1D Bracketing and matrixing designs for stability testing of new drug substances and products
Q1E Evaluation for stability data
Q2 Validation of analytical procedures: text and methodology
Q3A Impurities in new drug substances
Q3B Impurities in new drug products
Q3C Impurities: guideline for residual solvents
Q4 Pharmacopoeias
Q5B Quality of biotechnological products: analysis of the expression construct in cells used for production of r-dna derived protein products
Q5C Quality of biotechnological products: stability testing of  biotechnological/biological    products
Q5D Derivation and characterization of cell substrates used for production of biotechnological/biological products
Q5E Comparability of biotechnological/biological products subject to changes in their Manufacturing process
Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Q6B Specifications: test procedures and acceptance criteria for  biotechnological/biological products
Q7 Good Manufacturing practice for API (GMP)
Q8 Pharmaceutical development
Q9 Quality Risk Management (QRM)
Q10 Pharmaceutical Quality System (PQS)
Q11 Development & Manufacture of Drug substance (DMDS)
Technical & Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Q13 Continuous Manufacturing for Drug Substances and Drug Products
Q14 Analytical Procedure Development and Revision of Q2 (R1)
Analytical Validation
ICH Q1 to Q14

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