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This page allows for easy navigation of the EU GMP Guide - For Quick Reference only
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Main Document - Chapters

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Back to Tern-Quay  Annexes

INTRO	INTRODUCTION
CHAPTER 1:	QUALITY MANAGEMENT
	Quality Assurance Good Manufacturing Practice for Medicinal Products Quality Control
CHAPTER 2:	PERSONNEL
	Key Personnel Training Personnel Hygiene
CHAPTER 3:	PREMISES AND EQUIPMENT
	Premises Production Area Storage Area Quality Control Area Ancillary Areas Equipment
CHAPTER 4:	DOCUMENTATION
	General Documents Required Specifications Manufacturing Formulae and Processing Instructions Packaging Instructions Batch Processing / Packaging Records Procedures and Records Receipt Sampling Testing
CHAPTER 5:	PRODUCTION
	General Prevention of Cross-contamination in Production Validation Starting Materials Processing Operations: Intermediate and Bulk Products Packaging Materials Packaging Operations Finished Products Rejected, Recovered and Returned Materials
CHAPTER 6:	QUALITY CONTROL
	General Good Quality Control Laboratory Practice Documentation Sampling Testing
CHAPTER 7:	CONTRACT MANUFACTURE AND ANALYSIS
	General The Contract Giver The Contract Acceptor The Contract
CHAPTER 8:	COMPLAINTS AND PRODUCT RECALL
	Complaints Recalls
CHAPTER 9:	SELF INSPECTION