Download Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 Aka the Orange Guide PDF

TitleRules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 Aka the Orange Guide
Tags Wellness Pharmacovigilance
File Size1.6 MB
Total Pages449
Table of Contents
                            Cover
Table of Contents
Preface to the 2007 edition
	GMP Directive
	Changes to the Community Code
	UK legislation
	Changes to the EU Guide to GMP
	The “Orange Guide’’ 2007
Acknowledgements
Feedback
Introduction
SECTION I: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
	1 MHRA: Licensing, Inspection and Enforcement for Human Medicines
		Overview of MHRA
		Inspectorate
		Licensing Office
		Defective Medicines Report Centre (DMRC)
		Enforcement and Intelligence Group
		Advice
SECTION II: GUIDANCE ON GOOD MANUFACTURING PRACTICE (GMP)
	The MHRA Index to the EU Guide to GMP
	2 EU Guidance on Good Manufacturing Practice
		PART I: Basic Requirements for Medicinal Products
			Introduction
			1 QUALITY MANAGEMENT
				Principle
				Quality Assurance
				Good Manufacturing Practice for Medicinal Products (GMP)
				Quality Control
				Product Quality Review
			2 PERSONNEL
				Principle
				General
				Key Personnel
				Training
				Personnel Hygiene
			3 PREMISES AND EQUIPMENT
				Principle
				Premises
				Equipment
			4 DOCUMENTATION
				Principle
				General
				Documents Required
				Manufacturing Formula and Processing Instructions
				Packaging Instructions
				Batch Processing Records
				Batch Packaging Records
				Procedures and Records
			5 PRODUCTION
				Principle
				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
			6 QUALITY CONTROL
				Principle
				General
				Good Quality Control Laboratory Practice
			7 CONTRACT MANUFACTURE AND ANALYSIS
				Principle
				General
				The Contract Giver
				The Contract Acceptor
				The Contract
			8 COMPLAINTS AND PRODUCT RECALL
				Principle
				Complaints
				Recalls
			9 SELF INSPECTION
				Principle
			ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS
				Principle
				General
				Isolator Technology
				Blow/Fill/Seal Technology
				Terminally Sterilised Products
				Aseptic Preparation
				Personnel
				Premises
				Equipment
				Sanitation
				Processing
				Sterilisation
				Sterilisation by Heat
				Moist Heat
				Dry Heat
				Sterilisation by Radiation
				Sterilisation with Ethylene Oxide
				Filtration of Medicinal Products which cannot be Sterilised in their Final Container
				Finishing of Sterile Products
				Quality Control
			ANNEX 2 MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE
				Scope
				Principle
				Personnel
				Premises and Equipment
				Animal Quarters and Care
				Documentation
				Production
				Quality Control
			ANNEX 3 MANUFACTURE OF RADIOPHARMACEUTICALS
				Principle
				Personnel
				Premises and Equipment
				Production
				Quality Control
				Distribution and Recalls
			ANNEX 4 MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
				Manufacture of Premixes for Medicated Feedingstuffs
				Manufacture of Ectoparasiticides
				Manufacture of Veterinary Medicinal Products Containing Penicillins
				Retention of Samples (point 1.4 viii and point 6.14)
				Sterile Veterinary Medicinal Products
			ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
				Principle
				Personnel
				Premises
				Equipment
				Animals and Animal Houses
				Disinfection–Waste Disposal
				Production
				Starting Materials
				Quality control
			ANNEX 6 MANUFACTURE OF MEDICINAL GASES
				1 Principle
				2 Personnel
				3 Premises and Equipment
				4 Documentation
				5 Production
				6 Quality Control
				7 Storage and Release
				Glossary
			ANNEX 7 MANUFACTURE OF HERBAL MEDICINAL PRODUCTS
				Principle
				Premises
				Documentation
				Sampling
				Quality Control
			ANNEX 8 SAMPLING OF STARTING AND PACKAGING MATERIALS
				Principle
				Personnel
				Starting Materials
				Packaging Material
			ANNEX 9 MANUFACTURE OF LIQUIDS, CREAMS AND OINTMENTS
				Principle
				Premises and Equipment
				Production
			ANNEX 9 MANUFACTURE OF LIQUIDS, CREAMS AND OINTMENTS
				Principle
				Premises and Equipment
				Production
			ANNEX 10 MANUFACTURE OF PRESSURISED METERED DOSE AEROSOL PREPARATIONS FOR INHALATION
				Principle
				General
				Premises and Equipment
				Production and Quality Control
			ANNEX 11 COMPUTERISED SYSTEMS
				Principle
				Personnel
				Validation
				System
			ANNEX 12 USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS
				Introduction
				Responsibilities
				Dosimetry
				Validation of the Process
				Commissioning of the Plant
				Premises
				Processing
				Documentation
				Microbiological Monitoring
			ANNEX 13 MANUFACTURE OF INVESTIGATIONAL MEDICINAL PRODUCTS
				Principle
				Glossary
				Quality Management
				Personnel
				Premises and Equipment
				Documentation
				Production
				Quality Control
				Release of Batches
				Shipping
				Complaints
				Recalls and Returns
				Destruction
			ANNEX 14 MANUFACTURE OF MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR PLASMA
				Principle
				Glossary
				Quality Management
				Premises and Equipment
				Blood and Plasma Collection
				Traceability and Post Collection Measures
				Production and Quality Control
				Retention of Samples
				Disposal of Rejected Blood, Plasma or Intermediates
			ANNEX 15 QUALIFICATION AND VALIDATION
				Principle
				Planning for Validation
				Documentation
				Qualification
				Process Validation
				Cleaning Validation
				Change Control
				Revalidation
				Glossary
			ANNEX 16 CERTIFICATION BY A QUALIFIED PERSON AND BATCH RELEASE
				1 Scope
				2 Principle
				3 Introduction
				4 General
				5 Batch Testing and Release of Products Manufactured in EC/EEA
				6 Batch Testing and Release of Products Imported from a Third Country
				7 Batch Testing and Release of Products Imported from a Third Country with which the EC has a Mutual Recognition Agreement (MRA)
				8 Routine Duties of a Qualified Person
				9 Glossary
			ANNEX 17 PARAMETRIC RELEASE
				1 Principle
				2 Parametric Release
				3 Parametric Release for Sterile Products
				4 Glossary
			ANNEX 18 GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
			ANNEX 19 REFERENCE AND RETENTION SAMPLES
				1 Scope
				2 Principle
				3 Duration of Storage
				4 Size of Reference and Retention Samples
				5 Storage Conditions
				6 Written Agreements
				7 Reference Samples – General Points
				8 Retention Samples – General Points
				9 Reference and Retention Samples for Parallel Imported/Parallel Distributed Products.
				10 Reference and Retention Samples in the Case of Closedown of a Manufacturer
			GLOSSARY OF TERMS USED IN THE EU GUIDE TO GMP
		PART II: Basic Requirements for Active Substances Used as Starting Materials
			1 Introduction
			2 Quality Management
			3 Personnel
			4 Buildings and Facilities
			5 Process Equipment
			6 Documentation and Records
			7 Materials Management
			8 Production and In-Process Controls
			9 Packaging and Identification Labelling of APIs and Intermediates
			10 Storage and Distribution
			11 Laboratory Controls
			12 Validation
			13 Change Control
			14 Rejection and Re-Use of Materials
			15 Complaints and Recalls
			16 Contract Manufacturers (including Laboratories)
			17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
			18 Specific Guidance for APIs Manufactured by CellCulture/Fermentation
			19 APIs for Use in Clinical Trials
			20 Glossary to Part II
	3 UK Guidance on Manufacture
		Manufacturers’ Obligations
		Qualified Persons
		Code of Practice for Qualified Persons in the Pharmaceutical Industry
		Appendix 1: UK Statements on CPD
		Import from Third Countries
		Mutual Recognition Agreements on Good Manufacturing Practice (GMP) and Manufacturing Authorisation
		Content of the Fabricator’s/Manufacturer’s Batch Certificate for Drug/Medicinal Products Exported to Countries Under the Scope of a Mutual Recognition Agreement (MRA)
		UK Guidance on Certificates of Analysis
		GMP for Starting Materials
		Manufacture and Importation of Unlicensed Medicines for Human Use
SECTION III: LEGISLATION ON MANUFACTURE
	4 EU Legislation on Manufacture
		DIRECTIVE 2001/83/EC, AS AMENDED, TITLE IV, MANUFACTURE AND IMPORTATION
		DIRECTIVE 2003/94/EC, LAYING DOWN THE PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE FOR HUMAN MEDICINES
	5 UK Legislation on Manufacture
		The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005 No. 2789)
		Schedule 1 of the Regulations
		Schedule 2 of the Regulations
		Schedule 3 of the Regulations
		Prescribed Conditions for Manufacturer’s Undertakings for Imported Products (SI 1977 No. 1038)
		Schedule
SECTION IV: GUIDANCE ON WHOLESALE DISTRIBUTION PRACTICE
	6 EU Guidance on Wholesale Distribution Practice
		GUIDELINES ON GOOD DISTRIBUTION PRACTICE OF MEDICINAL PRODUCTS FOR HUMAN USE (94/C 63/03)
			Introduction
			Principle
			Personnel
			Documentation
			Premises and equipment
			Deliveries to customers
			Returns
			Self inspections
			Provision of information to Member States in relation to wholesale activities
	7 UK Guidance on Wholesale Distribution Practice
		Wholesale Dealer’s Obligations
		Appointment and Duties of the Responsible Person
		Control and Monitoring of Storage and Transportation Temperatures
		Counterfeits/Ensuring Bona Fides
		Diverted Medicines
		Parallel Distribution
		Continued Supply
		Product Recall/Withdrawal
SECTION V: LEGISLATION ON WHOLESALE DISTRIBUTION
	8 EU Legislation on Wholesale Distribution
		DIRECTIVE 2001/83/EC, AS AMENDED, TITLE VII, WHOLESALE DISTRIBUTION
			Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2004/27/EC.
			Title VII: Wholesale Distribution of Medicinal Products
	9 UK Legislation on Wholesale Distribution
		The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005 No. 2789)
SECTION VI: GLOSSARY OF LEGISLATION
	Glossary of Legislation
		European Legislation
		Primary (UK) Legislation
		Secondary Legislation (UK Statutory Instruments)
SECTION VII: INDEX
	Index
                        

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