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Table Of Contents

Glossary
1.Quality assurance
3.Sanitation and hygiene
4.Qualification and validation
5.Complaints
6.Product recalls
7.Contract production and analysis
General
The contract giver
The contract accepter
The contract
8.Self-inspection and quality audits
Items for self-inspection
Self-inspection team
Frequency of self-inspection
Self-inspection report
Follow-up action
Quality audit
Suppliers’ audits and approval
9.Personnel
Key personnel
10.Training
11.Personal hygiene
12.Premises
Ancillary areas
Storage areas
Weighing areas
Production areas
Quality control areas
13.Equipment
14.Materials
Starting materials
Packaging materials
Intermediate and bulk products
Rejected, recovered, reprocessed and reworked materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
Miscellaneous
15.Documentation
Documents required
16.Good practices in production
Processing operations
Packaging operations
17.Good practices in quality control
Test requirements
Batch record review
Stability studies
References
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Published by vi_wivia

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Published by: vi_wivia on Mar 19, 2014
Copyright:Attribution Non-commercial

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03/20/2014

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