WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report: Annex 4. Good manufacturing practices: authorized person - role, functions and training: 5. Selected references

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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish]

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Documentos relacionados

Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5

Índice de contenido

	WHO Expert Committee on Specifications for Pharmaceutical Preparations
	1. Introduction
	2. The international pharmacopoeia and related issues
		2.1 Quality specifications for drug substances and dosage forms
		2.2 Simple test methodology
	3. International Chemical Reference Substances and Infrared Reference Spectra
		3.1 Establishment of International Chemical Reference Substances
		3.2 International Infrared Reference Spectra
		3.3 Use of International Chemical Reference Substances and Infrared Reference Spectra
		3.4 Guidelines for the establishment, maintenance and distribution of chemical reference substances
	4. Quality control - national laboratories
		4.1 Good laboratory practices in government drug quality control laboratories
		4.2 Information on external quality assessment
	5. Good manufacturing practices
		5.1 Adoption of additional guidelines
		5.2 Good manufacturing practices for sterile products
		5.3 Relationship between pharmacopoeial requirements and manufacturers' internal specifications
	6. Quality systems and inspection
		6.1 Quality systems for GMP inspectorates
		6.2 Pre-approval inspection
		6.3 Guidelines for inspection of drug distribution channels
		6.4 Use of simple test methods by inspectors
	7. Other quality assurance topics
		7.1 Compendia
		7.2 Packaging for pharmaceutical products
		7.3 Multisource pharmaceutical products
		7.4 Guidelines for good pharmacy practice
	8. Nomenclature and terminology
		8.1 International Nonproprietary Names for pharmaceutical substances
		8.2 Terminology
	9. Legal aspects of pharmaceuticals
		9.1 Drug regulatory legislation
		9.2 National implementation guidelines for combating counterfeit pharmaceuticals
	10. Regulatory issues
		10.1 WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
			10.1.1 Finished pharmaceutical products
			10.1.2 Active pharmaceutical ingredients
		10.2 WHO model system for computer-assisted drug registration
		10.3 Model guidelines for the international provision of controlled medicines for emergency medical care
	11. Training activities
		11.1 Training programmes for drug regulators and related activities
		11.2 Training programmes for the detection of counterfeit pharmaceutical products
	12. Pharmaceuticals contaminated with diethylene glycol
	Acknowledgements
	References
	Annex 1. List of available International Chemical Reference Substances¹
	Annex 2. List of available International Infrared Reference Spectra¹
	Annex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
		Introduction
		Part A. Primary chemical reference substances
			1. Assessment of need for the establishment of chemical reference substances
			2. Obtaining source material
			3. Evaluation of chemical reference substances
				3.1 Use in identification tests
				3.2 Use in purity tests
				3.3 Use in assays
				3.4 Use in the calibration of an instrument
			4. Chemical and physical methods used in evaluating chemical reference substances
				4.1 Methods used to verify the identity of chemical reference substances
				4.2 Methods used to determine the purity of chemical reference substances
			5. Assignment of content
			6. Handling and distribution of chemical reference substances
				6.1 Packaging operations
				6.2 Storage
				6.3 Stability
				6.4 Information to be supplied with chemical reference substances
				6.5 Distribution and supply
				6.6 Period of use
		Part B. Secondary chemical reference substances
		References
	Annex 4. Good manufacturing practices: authorized person - role, functions and training
		1. The role and position of the authorized person in the company
		2. Implementation of the quality system
		3. Routine duties of an authorized person
		4. Education and training
		5. Selected references
	Annex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
		1. General considerations
		2. Glossary
		3. Self-inspection and quality audits
		4. Equipment
			4.1 Use of equipment
			4.2 Cleaning programme
				4.2.1 Detailed cleaning procedure
				4.2.2 Sampling plan
				4.2.3 Analytical methods/cleaning limits
		5. Materials
			5.1 General
			5.2 Starting materials
			5.3 Rejected and recovered materials
			5.4 Returned excipients
			5.5 Storage practices
		6. Documentation
			6.1 General
			6.2 Specifications
			6.3 Batch production records
			6.4 Other documents
		7. Good practices in production and quality control
			7.1 Change control and process validation
			7.2 Good practices in production
				7.2.1 Prevention of cross-contamination
				7.2.2 In-process blending/mixing
				7.2.3 Control of microbial contamination
				7.2.4 Water systems/water quality
				7.2.5 Packaging operations
				7.2.6 Delivery
			7.3 Good practices in quality control
				7.3.1 General
				7.3.2 Control of starting materials
				7.3.3 In-process testing
				7.3.4 Quality records and retention samples
				7.3.5 Stability studies
				7.3.6 Expiry/re-evaluation dating
				7.3.7 Calibration of measuring and test equipment
	Annex 6. Guidelines for inspection of drug distribution channels
		Introductory note
		General considerations
		Glossary
		1. Drug inspectors
			1.1 Qualifications
			1.2 Organizational aspects
			1.3 Methods of inspection
			1.4 Reference/information sources
		2. Inspection of establishments in the drug distribution chain
			2.1 Broad objectives
			2.2 Establishments
			2.3 Inspections
			2.4 Special categories of drugs
		References
		Selected further reading
		Appendix 1. Checklist for inspection and the preparation of a report
		Appendix 2. Guidance on sampling
		Appendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
		Appendix 4. Sample receipt form
	Annex 7. Good pharmacy practice in community and hospital pharmacy settings
	Annex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
		Introduction
		Drafting national legislation: points for consideration
		Defining the scope of the marketing authorization procedure for medicinal products
		Example of a legislative scheme for regulating medicinal products
			General considerations
			Potential value of the scheme
			Model legislative text and commentary
				Part A. Administration
				Part B. Provisional registration/marketing authorization and inventory of medicinal products
				Part C. Screening of products and issuance of product licences/authorizations
				Part D. Other activities requiring authorization/licensing
				Part E. General provisions
				Part F. Interpretation
		References
		Selected bibliography
		Appendix 1. Provisional legislative scheme for registration of pharmacy personnel
		Appendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
	Annex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
		1. General remarks
			1.1 Introduction
			1.2 Requirements and goals of the training programmes for inspection and examination
			1.3 Prerequisites
		2. Training programme for inspection
			2.1 Course objectives
			2.2 Types of training
			2.3 Educational background of trainees and trainers
			2.4 Course programme items
			2.5 Duration of training course
			2.6 Reiterative training
			2.7 Assessment
			2.8 Certificate
			2.9 Evaluation of the programme
		3. Training programme on examination
			3.1 Course objectives
			3.2 Types of training
			3.3 Educational background of trainees and trainers
			3.4 Course programme items
			3.5 Duration of course
			3.6 Reiterative training
			3.7 Assessment
			3.8 Certificate
			3.9 Evaluation of the programme
		References
		World Health Assembly resolutions
		Appendix 1 The practical issues of organizing and implementing the programme
		Appendix 2 Thin-layer chromatography and its application
	World Health Organization Technical Report Series
	Selected WHO Publications of Related Interest
	Back Cover

5. Selected references

Code of practice for qualified persons. In: Rules and guidance for pharmaceutical manufacturers. London, Medicines Control Agency, 1993.

Current good manufacturing practice for finished pharmaceuticals. 21 CFR Part 211.

Current good manufacturing practice in manufacturing, processing, packing or holding of drugs. General. 21 CFR Part 210.

Guideline on preparation of investigational new drug products. March 1991.

Guidelines for developing quality manuals. International Standard ISO 10013. Geneva, International Organization for Standardization, 1995.

Guide to good manufacturing practice for medicinal products. In: The rules governing medicinal products in the European Union, Volume IV. Brussels, European Commission, 1992.

Model for quality assurance in design, development, production, installation and servicing. International Standard ISO 9001. Geneva, International Organization for Standardization, 1994.

Quality management and quality assurance - vocabulary. International Standard ISO 8402. Geneva, International Organization for Standardization, 1994.

Quality management and quality system elements. International Standard ISO 9004. Geneva, International Organization for Standardization, 1994.

Second Council Directive on the approximation of provisions laid down by law: regulation of administrative action relating to proprietary medicinal products. Brussels, European Commission, 1975 (75/319/EEC).

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