ICH Q6A Specifications: Test Procedures & Acceptance Criteria for New Drug Substance & Products
Channel: DR Technical Gyan
Date: 2020-06-10

ICH Q6A Specifications: Test Procedures & Acceptance Criteria for New Drug Substance & Products.
ICH GUIDELINE SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES (Q6A)

 INTRODUCTION 
1.1 Objective of the Guideline 
1.2 Background 
1.3 Scope of the Guideline 
2. GENERAL CONCEPTS 
2.1 Periodic or Skip Testing 
2.2 Release vs. Shelf-life Acceptance Criteria 
2.3 In-process Tests 
2.4 Design and Development Considerations 
2.5 Limited Data Available at Filing 
2.6 Parametric Release 
2.7 Alternative Procedures 
2.8 Pharmacopoeial Tests and Acceptance Criteria 
2.9 Evolving Technologies 
2.10 Impact of Drug Substance on Drug Product Specifications 
2.11 Reference Standard 
3. GUIDELINES 
3.1 Specifications: Definition and Justification 
3.1.1 Definition of Specifications 
3.1.2 Justification of Specifications