WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 917 - Thirty-eighth Report: Annex 2. Good trade and distribution practices for pharmaceutical starting materials: General considerations

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 917 - Thirty-eighth Report
(2003; 129 pages)

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Procedure for Assessing the Acceptability, in Principle, of Procurement Agencies for Use by United Nations Agencies. WHO Technical Report Series, No. 917, 2003, Annex 6

Índice de contenido

1. Introduction
2. General Policy
3. Quality control - specifications and tests
4. Quality control - International Reference Materials
5. Quality control - national laboratories
6. Quality assurance - good manufacturing practices
7. Quality assurance - inspection
8. Quality assurance - distribution and trade-related
9. Quality assurance - risk analysis
10. Quality assurance - drug supply
11. International Nonproprietary Names programme
12. Miscellaneous
Acknowledgements
References
Annex 1. Lists of available International Chemical Reference Substances and International Infrared Reference Spectra
Annex 2. Good trade and distribution practices for pharmaceutical starting materials
	Introductory note
	Scope
	General considerations
	Glossary
	1. Quality management
	2. Organization and personnel
	3. Premises
	4. Warehousing and storage
	5. Equipment
	6. Documentation
	7. Repackaging and relabelling
	8. Complaints
	9. Recalls
	10. Returned goods
	11. Handling of non-conforming materials
	12. Dispatch and transport
	13. Contract activities
	References
Annex 3. WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
	1. Provisions and objectives
	2. Participating Member States
	3. Requesting a certificate
	4. Certificates issued by competent regulatory authorities
	5. Certificates issued by manufacturers
	6. Notifying and investigating a quality defect
	References
	Further reading
	Appendix 1. Model Certificate for Pharmaceutical Starting Materials issued by the competent national authority
	Appendix 2. Model Certificate for Manufacture of Pharmaceutical Starting Materials issued by the manufacturer¹
	Appendix 3. Glossary and key words
Annex 4. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
	1. Introduction
	2. Steps of the procedure
		2.1 Publication of Invitation for Expression of Interest
		2.2 Submission of laboratory information file
		2.3 Screening of submitted laboratory information file
		2.4 Assessment of the laboratory information file
		2.5 Site inspection
		2.6 Report and outcome of evaluation
		2.7 Results of assessment
		2.8 Re-qualification
		2.9 Proficiency testing
		2.10 Monitoring of complaint(s)
		2.11 Cost recovery
		2.12 Confidentiality undertaking
		2.13 Conflict of interest
	Appendix. Provisions for inspectors (team members participating in site visits) within the scope of the quality assessment procedure of quality control laboratories
Annex 5. Guidelines for preparing a laboratory information file
Annex 6. Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
	1. Introduction
	2. Steps of the procedure
		2.1 Publication of Invitation for Expression of Interest
		2.2 Submission of a procurement agency information file
		2.3 Screening of submitted procurement agency information file
		2.4 Assessment of the procurement agency information file
		2.5 Site inspection
		2.6 Report and outcome of evaluation
		2.7 Results of assessment
		2.8 Re-qualification
		2.9 Testing of samples
		2.10 Monitoring of complaint(s)
		2.11 Cost recovery
		2.12 Confidentiality undertaking
		2.13 Conflict of interest
	Appendix. Provisions for inspectors (team members participating in site visits) within the scope of the quality assessment procedure of procurement agencies
Annex 7. Guidelines for the preparation of a procurement agency information file
Annex 8. Interim guidelines for the assessment of a procurement agency (based on the draft model quality assurance system for procurement agencies)
	1. Introduction and background
	2. Interim assessment tool for pre-qualification of a procurement agency site
Appendix. Attachment A: interim assessment guideline for procurement agencies - Pharmaceutical product questionnaire
Selected WHO Publications of Related Interest
Back Cover

General considerations

The objective of the implementation of these guidelines is to ensure the quality and integrity of the starting material and the pharmaceutical product.

The guidelines should be considered and implemented inter alia by suppliers, such as:

- pharmaceutical manufacturers, including manufacturers of intermediate and/or finished products;
- distributors;
- manufacturers of pharmaceutical starting materials;
- brokers; and
- other suppliers.

They are also relevant to:

- governments;
- regulatory bodies;
- international organizations and donor agencies involved in procurement tenders;
- relevant trade organizations;
- certifying bodies; and
- all parties involved in trade and distribution.

Member States should take appropriate measures to ensure the implementation of these guidelines. The guidelines can be used as one tool in the prevention of the trade in counterfeit and substandard medicines.

The importance of quality of the pharmaceutical starting materials used in the manufacture of pharmaceutical products cannot be over-emphasized. The marketing authorization dossier for a finished product should normally refer to the use of a pharmaceutical starting material from a specific source(s) in that product. The sourcing, storage, distribution and use of these starting materials are thus a shared responsibility.

The role of the producer, manufacturer, trader, broker or distributor in sharing the responsibility for a quality product is evident. Each must ensure that materials are of the quality required for use in the pharmaceutical industry, as each plays an important part in the manufacture and supply chain to ensure that a quality product is supplied to the patient.

For this reason, materials can only be reclassified from pharmaceutical grade to non-pharmaceutical grade and not from non-pharmaceutical grade to pharmaceutical grade.

Each batch of pharmaceutical starting material should normally be tested by its manufacturer for compliance with its specification. When results are obtained from skip lot testing this should be indicated on the Certificate of Analysis issued by the manufacturer.