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Table Of Contents

A.3 Reference to GMP Guide for industry
B. Glossary
1. Quality assurance system
1.1 Principles
1.2 Quality assurance
1.3 Good Preparation Practice for medicinal products
1.4 Quality control
2. Personnel
2.1 Principles
2.2 General requirements
2.3 Training and continued education
2.4 Hygiene
3. Premises and equipment
3.1 Principles
3.2 General requirements
3.3 Production areas
3.4 Storage areas
3.5 Quality control areas
3.6 Ancillary areas
3.7 Equipment
4. Documentation
4.1 Principles
4.2 General requirements
4.3 Documentation for extemporaneously prepared products
4.4 Documentation for products prepared regularly or for stock
4.4.1 Specifications
4.4.2 Instructions
4.4.3 Records
4.5 General procedures and additional documentation
5. Production
5.1 Principles
5.2 General requirements
5.3 Prevention of cross contamination
5.4 Product risk assessment and demonstration of suitability
5.5 Starting materials
5.6 Processing operations
5.7 Packaging material
5.8 Packaging operations
5.9 Rejected, recovered and returned materials and products
6. Quality control
6.1 Principles
6.2 General requirements
6.3 Sampling
6.4 Testing
6.5 Release
7. Work contracted out
7.1 Principles
7.2 General requirements
7.3 Contract giver
7.4 Contract acceptor
8. Complaints and product recalls
8.1 Principles
8.2 Quality problems
8.3 Recalls
9. Self audits
9.1 Principles
Preparation of terminally sterilized products
Sterilisation by Moist Heat
Aseptic Processing
Classification “at rest”
Environmental monitoring “in operation”
Test limits for monitoring
Premises and Equipment
Reference sources
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PE 010 3 Revised GPP Guide

PE 010 3 Revised GPP Guide

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Published by mokhzanni

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Published by: mokhzanni on Oct 01, 2010
Copyright:Attribution Non-commercial


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