WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report: Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles: Quality management in the drug industry: philosophy and essential elements 1 : 14. Materials: Intermediate and bulk products

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages)

Índice de contenido

WHO Expert Committee on Specifications for Pharmaceutical Preparations
1. Introduction
2. General policy
	2.1 Specifications for medicinal plant materials and for herbal products
	2.2 Risk of transmitting animal spongiform encephalopathy agents via medicinal products
	2.3 Stop TB programme
	2.4 Roll Back Malaria programme
	2.5 HIV/AIDS programme
	2.6 Future of The International Pharmacopoeia
	2.7 Pharmacopoeial Discussion Group (PDG)¹
	2.8 International Conference on Harmonisation (ICH)
3. Quality control - specifications and tests
	3.1 Thin-layer chromatography screening tests for antimalarials
	3.2 Radiopharmaceuticals
	3.3 Pharmacopoeial monographs on antiretrovirals
	3.4 Thin-layer chromatography screening tests for antituberculosis drugs
	3.5 Draft monograph on rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride tablets
4. Quality control - international reference materials
5. Quality control - national laboratories
	5.1 External quality assessment scheme
	5.2 Cost estimate of equipment for model quality control laboratories
6. Quality assurance - good manufacturing practices
	6.1 Specific GMP guidelines for radiopharmaceutical products
	6.2 GMP guidelines for active pharmaceutical ingredients
	6.3 WHO GMP: main principles for pharmaceutical products
	6.4 WHO basic training modules on GMP
7. Quality assurance - inspection
	7.1 Model certificate of GMP
	7.2 Guidance for GMP inspection report
8. Quality assurance - distribution and trade-related
	8.1 Good trade and distribution practices of pharmaceutical starting materials
	8.2 WHO Scheme for the Certification of Pharmaceutical Starting Materials Moving in International Commerce: guidelines on implementation
	8.3 WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
9. Quality assurance - risk analysis
	9.1 Risk analysis in quality control and impurities
	9.2 Application of hazard analysis and critical control point methodology for pharmaceuticals
10. Quality assurance - drug supply
	10.1 Procedure for assessing the acceptability for purchase of pharmaceutical products
	10.2 Procedure for assessing the acceptability for purchase of pharmaceutical products for the treatment of HIV/AIDS
11. Quality assurance - storage
	11.1 WHO guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
	11.2 Good storage practices
12. International Nonproprietary Names (INNs) programme
13. Miscellaneous
	13.1 Proposal to the WHO Expert Committee by the Scientific Working Group on Bioequivalence of the International Pharmaceutical Federation (FIP)
	13.2 Dissolution tests for quality control
	13.3 Electronic version of publications
	13.4 Standardized reporting sheet
	13.5 Distribution of documents for procedural consultation process
Acknowledgements
References
Annex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
Annex 2 The International Pharmacopoeia: revised concepts and future perspectives
Annex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
	1. Scope of these guidelines
	2. Principles
	3. Personnel
	4. Premises and equipment
	5. Production
	6. Labelling
	7. Production and distribution records
	8. Quality assurance and quality control
	Acknowledgements
	References
Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles
	Introduction
	General considerations
	Glossary
	Quality management in the drug industry: philosophy and essential elements¹
		1. Quality assurance
		2. Good manufacturing practices for pharmaceutical products (GMP)
		3. Sanitation and hygiene
		4. Qualification and validation
		5. Complaints
		6. Product recalls
		7. Contract production and analysis
			General
			The contract giver
			The contract accepter
			The contract
		8. Self-inspection and quality audits
			Items for self-inspection
			Self-inspection team
			Frequency of self-inspection
			Self-inspection report
			Follow-up action
			Quality audit
			Suppliers’ audits and approval
		9. Personnel
			General
			Key personnel
		10. Training
		11. Personal hygiene
		12. Premises
			General
			Ancillary areas
			Storage areas
			Weighing areas
			Production areas
			Quality control areas
		13. Equipment
		14. Materials
			General
			Starting materials
			Packaging materials
			Intermediate and bulk products
			Finished products
			Rejected, recovered, reprocessed and reworked materials
			Recalled products
			Returned goods
			Reagents and culture media
			Reference standards
			Waste materials
			Miscellaneous
		15. Documentation
			General
			Documents required
		16. Good practices in production
			General
			Prevention of cross-contamination and bacterial contamination during production
			Processing operations
			Packaging operations
		17. Good practices in quality control
			Control of starting materials and intermediate, bulk and finished products
			Test requirements
			Batch record review
			Stability studies
	References
Annex 5 Model certificate of Good Manufacturing Practices
Annex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Annex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
	1. Introduction
	2. Steps of the procedure
		2.1 Publication of Invitation for Expression of Interest (EOI)
		2.2 Submission of Dossiers
		2.3 Screening of dossiers submitted
		2.4 Dossier assessment
		2.5 Site Inspection
		2.6 Report and outcome of evaluation
		2.7 Assessment results
		2.8 Procurement, sourcing and supply
		2.9 Re-evaluation
		2.10 Testing of samples
		2.11 Monitoring of Complaint(s)
		2.12 Cost Recovery
		2.13 Confidentiality Undertaking
		2.14 Conflict of Interest
	Appendix Provisions for evaluators of product dossiers and for inspectors (team member participating in site visits) within the scope of the quality assessment procedure of pharmaceutical products
	References
Annex 9 Guide to good storage practices for pharmaceuticals¹
	1. Introduction
	2. Glossary
	3. Personnel
	4. Premises and facilities
	5. Storage requirements
	6. Returned goods
	7. Dispatch and transport
	8. Product recall
	References
	Bibliography
	Appendix Storage and labelling conditions²
Back cover

Intermediate and bulk products

14.24 Intermediate and bulk products should be kept under appropriate conditions.

14.25 Intermediate and bulk products purchased as such should be handled on receipt as though they were starting materials.