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Table Of Contents

1 INTRODUCTION
1.1 Purpose and Scope
1.2 Principles Adopted
1.2.1 The Guide and its Use
1.2.3 Quality System Standard
1.3 Document Structure
2 DEFINITIONS
3 GENERAL GUIDANCE
3.1 Cosmetic ingredients
3.2 Applying cosmetic ingredient GMP
4.1 General Requirements
4.2 Documentation Requirements
4.2.3 Control of Documents
4.2.4 Control of Quality Records
5 MANAGEMENT RESPONSIBILITY
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
6 RESOURCE MANAGEMENT
6.1 Provision of Resources
6.2.2 Competence, Awareness and Training
6.2.3 Personnel Hygiene
6.3.1 Buildings and Facilities
6.3.2.1 Equipment Construction
6.3.2.2 Equipment Maintenance
6.3.2.3 Computer Systems
6.3.3 Utilities used in manufacture of cosmetic ingredients
6.3.4 Water used in manufacture of cosmetic ingredients
6.4 Work Environment
6.4.5 Washing and Toilet Facilities
7 PRODUCT REALIZATION
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.2.3 Customer Communication
7.3 Design and Development
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.1.1 Production Instructions and Records
7.5.1.2 Equipment Cleaning
7.5.1.3 Recovery of Solvents, Mother Liquors and Second Crop Crystallizations
7.5.1.4 In-process Blending/Mixing
7.5.1.5 In-process Control
7.5.1.6 Packaging and Labelling
7.5.1.7 Records of Equipment Use
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Identification and Traceability
7.5.3.1 Traceability
7.5.3.2 Inspection and Test Status
7.5.4 Customer Property
7.5.5 Preservation of Product
7.5.5.1 Handling, Storage, and Preservation
7.5.5.2 Packaging Systems
7.5.5.3 Delivery and Distribution
7.6 Control of Measuring and Monitoring Devices
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.2.4.1 Laboratory Controls
8.2.4.2 Cosmetic Ingredient Testing and Release
8.2.4.3 Out-of-Specification Test Results
8.2.4.4 Retained Samples
8.2.4.5 Certificates of Analysis
8.2.4.8 Expiry/Retest Periods
8.3 Control of Nonconforming Product
8.3.1 Reprocessing/Reworking
8.3.2 Returned cosmetic ingredients
8.4 Analysis of Data
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
APPENDIX A DEFINITIONS AND GLOSSARY
APPENDIX B REFERENCES
APPENDIX C ADDITIONAL SOURCES OF INFORMATION
APPENDIX E EFfCI GMP CERTIFICATION SCHEME RULES
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GMP Guild for Cosmetic Ingredient

GMP Guild for Cosmetic Ingredient

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Published by Lennon Tan Qin Ji

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Published by: Lennon Tan Qin Ji on Dec 28, 2011
Copyright:Attribution Non-commercial

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04/03/2014

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