PharmD Info

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