 (1) (1).png){kind=logo}
- 25 Nov 2022, 16:21
#5377
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
