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List of Pharmaceutical Guidelines for Quality Assurance


  • 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 rDNA 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
  • Q13- Continuous Manufacturing for Drug Substances and Drug Products
  • Q14—Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

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