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Industry Issues: Contamination Control Strategy, Data Integrity, QbD

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Korean GMP

 

 

GMP Case Study: Lessons from FDA 483s & Warning Letters

 

 


ICH Guidelines

 

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(R1)

Validation of Analytical Procedures: Text and Methodology

Q2(R2)

Validation of Analytical Procedures (Draft Version, 2022. 3. 24.)

 

 

Q3A(R2)

Impurities in New Drug Substances

Q3B(R2)

Impurities in New Drug Products

 

 

Q5A(R1)

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Q5A(R2)

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (draft, 2022. 9. 29.)

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

Quality Risk Management

Q9(R1)

Quality Risk Management (draft, 2021. 11. 18.)

   

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 (Draft Version, 2022. 3. 24)

 


 

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