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)
Q12	Technical & Regulatory Considerations for Pharmaceutical Product Lifecycle Management