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Table Of Contents

QUALITY ASSURANCE
GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP)
QUALITY CONTROL
PRODUCT QUALITY REVIEW
QUALITY RISK MANAGEMENT
GENERAL
KEY PERSONNEL
TRAINING
PERSONAL HYGIENE
PREMISES
General
Production Area
Storage Areas
Quality Control Areas
Ancillary Areas
EQUIPMENT
DOCUMENTS REQUIRED
Specifications
Specifications for starting and packaging materials
Specifications for intermediate and bulk products
Specifications for finished products
MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS
PACKAGING INSTRUCTIONS
BATCH PROCESSING RECORDS
BATCH PACKAGING RECORDS
PROCEDURES AND RECORDS
Receipt
Sampling
Testing
Other
PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION
VALIDATION
STARTING MATERIALS
PROCESSING OPERATIONS - INTERMEDIATE AND BULK PRODUCTS
PACKAGING OPERATIONS
FINISHED PRODUCTS
REJECTED, RECOVERED AND RETURNED MATERIALS
GOOD QUALITY CONTROL LABORATORY PRACTICE
DOCUMENTATION
SAMPLING
TESTING
ON-GOING STABILITY PROGRAMME
THE CONTRACT GIVER
THE CONTRACT ACCEPTOR
THE CONTRACT
COMPLAINTS
RECALLS
Chapter 9 Self Inspection
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gmp PICS

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Published by Nor Zahidah

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Published by: Nor Zahidah on Nov 11, 2010
Copyright:Attribution Non-commercial

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02/23/2012

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