Ich Q7

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

ICH HARMONISED TRIPARTITE GUIDELINE

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS Q7

Current Step 4 version dated 10 November 2000

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject toconsultation 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.

Q7 Document History
New Codification November 2005 Q7

First Codification

History

Date

Q7A

Approval by the Steering Committee under Step 2 and release for public consultation.

19July 2000

Current Step 4 version
Q7A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 10 November 2000 Q7

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, thisguideline is recommended for adoption to the three regulatory parties to ICH

TABLE OF CONTENTS
1. INTRODUCTION.............................................................................................................. 1 1.1 1.2 1.3 2. 2.1 2.2 2.3 2.4 2.5 3. 3.1 3.2 3.3 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 5. 5.1 5.2 5.3 5.4 Objective................................................................................................................ 1 Regulatory Applicability ....................................................................................... 1 Scope ...................................................................................................................... 1 Principles............................................................................................................... 4 Responsibilities of the Quality Unit(s)................................................................. 4 Responsibility for Production Activities............................................................... 5 Internal Audits (Self Inspection).......................................................................... 5 Product Quality Review........................................................................................ 6 Personnel Qualifications....................................................................................... 6 Personnel Hygiene ................................................................................................ 6Consultants............................................................................................................ 7 Design and Construction ...................................................................................... 7 Utilities .................................................................................................................. 8 Water ..................................................................................................................... 8Containment.......................................................................................................... 8 Lighting ................................................................................................................. 9 Sewage and Refuse................................................................................................ 9 Sanitation and Maintenance................................................................................ 9 Design and Construction ...................................................................................... 9 Equipment Maintenance and Cleaning ............................................................. 10 Calibration........................................................................................................... 11 Computerized...