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ICH Guidelines

ICH Guidelines

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ICH Guidelines for BA BE research And Clinical Research
ICH Guidelines for BA BE research And Clinical Research

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Published by: api-3698598 on Oct 18, 2008
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03/18/2014

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED TRIPARTITE GUIDELINE
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FORNEWDRUGSUBSTANCES ANDNEWDRUGPRODUCTS:
CHEMICALSUBSTANCES
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
First
Codification
History
Date
New
Codification
November
2005
Q6A
Approval by the Steering Committee under Step 2
and release for public consultation.

18
July
1997

Q6A
Current Step 4 version
Q6A

Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.

6
October
1999

Q6A
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FORNEWDRUGSUBSTANCES ANDNEWDRUGPRODUCTS:
CHEMICALSUBSTANCES
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
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