INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE
ICH HARMONISED TRIPARTITE GUIDELINE
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:
CHEMICAL SUBSTANCES
Q6A
Current Step 4 version
dated 6 October 1999
This Guideline has been developed by the appropriate ICH Expert Working Group and
has been subject to consultation by the regulatory parties, in accordance with the ICH
Process. At Step 4 of the Process the final draft is recommended for adoption to the
regulatory bodies of the European Union, Japan and USA.
, Q6A
Document History
New
First Codification
History Date
Codification November
2005
Q6A Approval by the Steering Committee under Step 2 18 Q6A
and release for public consultation. July
1997
Current Step 4 version
Q6A Approval by the Steering Committee under Step 4 and 6 Q6A
recommendation for adoption to the three ICH October
regulatory bodies. 1999
, SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:
CHEMICAL SUBSTANCES
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 6 October 1999, this guideline is recommended for
adoption to the three regulatory parties to ICH
TABLE OF CONTENTS
1. INTRODUCTION...................................................................................................... 1
1.1 Objective of the Guideline .............................................................................. 1
1.2 Background ..................................................................................................... 1
1.3 Scope of the Guideline .................................................................................... 1
2. GENERAL CONCEPTS ........................................................................................... 2
2.1 Periodic or Skip Testing ................................................................................. 2
2.2 Release vs. Shelf-life Acceptance Criteria ..................................................... 2
2.3 In-process Tests .............................................................................................. 3
2.4 Design and Development Considerations ..................................................... 3
2.5 Limited Data Available at Filing ................................................................... 3
2.6 Parametric Release ......................................................................................... 4
2.7 Alternative Procedures ................................................................................... 4
2.8 Pharmacopoeial Tests and Acceptance Criteria ........................................... 4
2.9 Evolving Technologies .................................................................................... 5
2.10 Impact of Drug Substance on Drug Product Specifications ......................... 5
2.11 Reference Standard ........................................................................................ 5
3. GUIDELINES ............................................................................................................ 5
3.1 Specifications: Definition and Justification .................................................. 5
3.1.1 Definition of Specifications ............................................................. 5
3.1.2 Justification of Specifications......................................................... 6
i
, Specifications: New Chemical Drug Substances and Products
3.2 Universal Tests / Criteria .............................................................................. 6
3.2.1 New Drug Substances .................................................................... 6
3.2.2 New Drug Products ........................................................................ 7
3.3 Specific Tests / Criteria .................................................................................. 8
3.3.1 New Drug Substances .................................................................... 8
3.3.2 New Drug Products ...................................................................... 10
4. GLOSSARY.............................................................................................................. 18
5. REFERENCES ........................................................................................................ 20
6. ATTACHMENTS .................................................................................................... 20
ii
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE
ICH HARMONISED TRIPARTITE GUIDELINE
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:
CHEMICAL SUBSTANCES
Q6A
Current Step 4 version
dated 6 October 1999
This Guideline has been developed by the appropriate ICH Expert Working Group and
has been subject to consultation by the regulatory parties, in accordance with the ICH
Process. At Step 4 of the Process the final draft is recommended for adoption to the
regulatory bodies of the European Union, Japan and USA.
, Q6A
Document History
New
First Codification
History Date
Codification November
2005
Q6A Approval by the Steering Committee under Step 2 18 Q6A
and release for public consultation. July
1997
Current Step 4 version
Q6A Approval by the Steering Committee under Step 4 and 6 Q6A
recommendation for adoption to the three ICH October
regulatory bodies. 1999
, SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:
CHEMICAL SUBSTANCES
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 6 October 1999, this guideline is recommended for
adoption to the three regulatory parties to ICH
TABLE OF CONTENTS
1. INTRODUCTION...................................................................................................... 1
1.1 Objective of the Guideline .............................................................................. 1
1.2 Background ..................................................................................................... 1
1.3 Scope of the Guideline .................................................................................... 1
2. GENERAL CONCEPTS ........................................................................................... 2
2.1 Periodic or Skip Testing ................................................................................. 2
2.2 Release vs. Shelf-life Acceptance Criteria ..................................................... 2
2.3 In-process Tests .............................................................................................. 3
2.4 Design and Development Considerations ..................................................... 3
2.5 Limited Data Available at Filing ................................................................... 3
2.6 Parametric Release ......................................................................................... 4
2.7 Alternative Procedures ................................................................................... 4
2.8 Pharmacopoeial Tests and Acceptance Criteria ........................................... 4
2.9 Evolving Technologies .................................................................................... 5
2.10 Impact of Drug Substance on Drug Product Specifications ......................... 5
2.11 Reference Standard ........................................................................................ 5
3. GUIDELINES ............................................................................................................ 5
3.1 Specifications: Definition and Justification .................................................. 5
3.1.1 Definition of Specifications ............................................................. 5
3.1.2 Justification of Specifications......................................................... 6
i
, Specifications: New Chemical Drug Substances and Products
3.2 Universal Tests / Criteria .............................................................................. 6
3.2.1 New Drug Substances .................................................................... 6
3.2.2 New Drug Products ........................................................................ 7
3.3 Specific Tests / Criteria .................................................................................. 8
3.3.1 New Drug Substances .................................................................... 8
3.3.2 New Drug Products ...................................................................... 10
4. GLOSSARY.............................................................................................................. 18
5. REFERENCES ........................................................................................................ 20
6. ATTACHMENTS .................................................................................................... 20
ii
