WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report: Annex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce: References

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:: Themes & Keywords

· Keywords > pharmaceutical preparations
· Keywords > specifications
· Keywords > WHO expert committee
· Keywords > préparations pharmaceutiques

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report
(1996; 200 pages)

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Table of Contents

	1. Introduction
	2. The international pharmacopoeia and related activities
		2.1. Quality specifications for drug substances and dosage forms
		2.2. Test methodology
		2.3. International Nonproprietary Names for pharmaceutical substances
		2.4. International Chemical Reference Substances and International Infrared Spectra
	3. Simple test methodology
	4. Stability of dosage forms
		4.1. Guidelines for the stability testing of pharmaceutical products containing established drug substances
		4.2. Joint WHO/UNICEF study on the quality of selected drugs at the point of use in developing countries
	5. Good manufacturing practices for pharmaceutical products
		5.1. Adoption of additional guidelines
		5.2. Further guidance on good manufacturing practices
	6. Legal and administrative aspects of the functioning of national drug regulatory authorities
		6.1. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
		6.2. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
		6.3. Guiding principles for formulating national drug legislation
		6.4. Role of the pharmacist
		6.5. Model legislative provisions to update national legal texts to deal with counterfeit drugs
		6.6. Additional guidance
		6.7. Training activities
	7. Quality assurance in the supply system
		7.1. Guidelines on import procedures for pharmaceutical products
		7.2. Guidelines for inspection of drug distribution channels
	8. Terminology
	Acknowledgements
	References
	Annex 1 - Guidelines for the graphic representation of chemical formulae
		1. Introduction
		2. Acyclic structures
		3. Cyclic structures
		4. Ionic structures
		5. Isotopically modified compounds
		6. Coordination compounds
		7. Stereochemistry
		8. Carbohydrates
		9. Steroids
		10. Terpenoids
		11. Prostanoids
		12. Alkaloids
		13. Antibiotics
		14. Polypeptides
		15. Polymers
		Acknowledgements
		References
	Annex 2 - List of available International Chemical Reference Substances¹
	Annex 3 - List of available International Infrared Reference Spectra
	Annex 4 - General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis
		1. Introduction
		2. Apparatus
		3. Method of verification of frequency scale and resolution
		4. Environment
		5. Use of solvents
		6. Preparation of the substance to be examined
		7. Identification by reference substance
		8. Identification by reference spectrum
		9. Reflectance techniques
	Annex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
		General
		Definitions
		1. Stability testing
		3. Design of stability studies
		4. Analytical methods
		5. Stability report
		6. Shelf-life and recommended storage conditions
		References
		Official, international and national guidelines
		Appendix 1 - Survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs: answer sheet
		Appendix 2 - Stability testing: summary sheet
	Annex 6 - Good manufacturing practices: guidelines on the validation of manufacturing processes
		Introduction
		Glossary
		General
		1. Types of process validation
		2. Prerequisites for process validation
		3. Approaches
		4. Organization
		5. Scope of a process validation programme
		6. Validation protocol and report
		References
		Bibliography
	Annex 7 - Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans
		1. Introductory note
		2. General considerations
		3. Glossary
		4. Quality assurance
		5. Validation¹
		6. Complaints
		7. Recalls
		8. Personnel
		9. Premises and equipment
		10. Materials
		11. Documentation
		12. Production
		13. Quality control
		14. Shipping, returns, and destruction
		References
	Annex 8 - Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products¹
		1. Glossary
		2. General
		3. Premises
		4. Documentation
		5. Quality control
		6. Stability tests
		References
	Annex 9 - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
		Introduction
		Glossary
		Part One. Regulatory assessment of interchangeable multisource pharmaceutical products
			1. General considerations
			2. Multisource products and interchangeability
			3. Technical data for regulatory assessment
			4. Product information and promotion
			5. Collaboration between drug regulatory authorities
			6. Exchange of evaluation reports
		Part Two. Equivalence studies needed for marketing authorization
			7. Documentation of equivalence for marketing authorization
			8. When equivalence studies are not necessary
			9. When equivalence studies are necessary and types of studies required
				In vivo studies
				In vitro studies
		Part Three. Tests for equivalence
			10. Bioequivalence studies in humans
				Subjects
				Design
				Studies of metabolites
				Measurement of individual isomers for chiral drug substance products
				Validation of analytical procedures
				Reserve samples
				Statistical analysis and acceptance criteria
				Reporting of results
			11. Pharmacodynamic studies
			12. Clinical trials
			13. In vitro dissolution
		Part Four. In vitro dissolution tests in product development and quality control
		Part Five. Clinically important variations in bioavailability leading to non-approval of the product
		Part Six. Studies needed to support new post-marketing manufacturing conditions
		Part Seven. Choice of reference product
		Authors
		References
		Appendix 1 - Examples of national requirements for in vivo equivalence studies for drugs included in the WHO Model List of Essential Drugs (Canada, Germany and the USA, December 1994)
		Appendix 2 - Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations
		Appendix 3 - Technical aspects of bioequivalence statistics
	Annex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
		1. Provisions and objectives
		2. Eligibility for participation
		3. Requesting a certificate
		4. Issuing a certificate
		5. Notifying and investigating a quality defect
		References
		Appendix 1 - Model Certificate of a Pharmaceutical Product
		Appendix 2 - Model Statement of Licensing Status of Pharmaceutical Product(s)
		Appendix 3 - Model Batch Certificate of a Pharmaceutical Product
		Appendix 4 - Glossary and index
	Annex 11 - Guidelines for the assessment of herbal medicines^1,2
		Introduction
		Assessment of quality
		Assessment of safety
		Assessment of efficacy
		Intended use
		Utilization of these guidelines
	Annex 12 - Guidelines on import procedures for pharmaceutical products
		1. Introductory notes
		2. Objectives and scope
		3. Legal responsibilities
		4. Legal basis of control
		5. Required documentation
		6. Implementation of controls
		7. Procedures applicable to pharmaceutical starting materials
		8. Storage facilities
		9. Training requirements
		References
		Glossary
		Appendix - Special import controls for narcotic drugs and psychotropic substances¹
	Back Cover

References

1. Quality control of drugs. In: Twenty-second World Health Assembly, Boston, Massachusetts, 8-25 July 1969. Part I: Resolutions and decisions, annexes. Geneva, World Health Organization, 1969: 99-105 (Official Records of the World Health Organization, No. 176).

2. Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. In: Twenty-eighth World Health Assembly, Geneva, 13-30 May 1975. Part 1: Resolutions and decisions, annexes. Geneva, World Health Organization, 1975: 94-95 (Official Records of the World Health Organization, No. 226).

3. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1992: 14-79 (WHO Technical Report Series, No. 823).

4. WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. In: Forty-first World Health Assembly, Geneva, 2-13 May 1988. Resolutions and decisions, annexes. Geneva, World Health Organization, 1988: 53-55 (document WHA41/1988/REC/1).

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