M4: The Common Technical Document

M4(R3)

Organization of The Common Technical Document for the Registration of Pharmaceuticals for Human Use

M4 Implementation Working Group - M4 Questions & Answers (R3)

M4Q(R1)

The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - Module 2: QOS & Module 3

M4Q Implementation Working Group - M4Q Questions & Answers (R1)

Quality Guidelines

Q1A(R2)

Stability Testing of New Drug Substances and Products

Q1B

Stability Testing: Photostability Testing of New Drug Substances and Products

Q1C

Sability 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(R2)

Validation of Analytical Procedures (2023. 11. 1.) New

Q5A(R2)

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (2023. 11. 1.) New

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 & Acceptance Criteria for New Drug Substances & New Drug Products: Chemical Substances

Q6B

Specifications: Test Procedures and Acceptance Criteria for Biotechnological / Biological Products

Q8(R2)

Pharmaceutical Development

Q9(R1)

Quality Risk Management (2023. 1. 18.) New

Q10

Pharmaceutical Quality System

ICH Q8, Q9, Q10 Questions & Answers

ICH Quality Implementation Working Group Points to Consider (R2): ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation

Q11

Development and Manufacture of Drug Substances

ICH Q11 Questions & Answers 

Q12

Technical & Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Q12

Annexes

Q13

Continuous Manufacturing of Drug Substances and Drug Products (Final version, 2022. 11. 16.)

Q14

Analytical Procedure Development (2023. 11. 1) New