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: 5. Equipment

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

Table des matières

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

5. Equipment

5.1 Equipment must be located, designed, constructed, adapted, used and maintained to suit the operations to be carried out. Defective equipment should not be used, and should either be removed or labelled as defective. Equipment should be disposed of in such a way as to prevent any misuse.

5.2 The layout, design and use of equipment must aim to minimize the risk of errors and to permit effective cleaning and maintenance to avoid cross-contamination, build-up of dust or dirt and any adverse effect on the quality of materials.

5.3 Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.

5.4 All services, piping and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases, liquids and other materials.

5.5 Balances and other measuring equipment of an appropriate range and precision should be available and should be calibrated on a scheduled basis.

5.6 Procedures should be in place for the operation and maintenance of equipment. Lubricants and other materials used on surfaces that come into direct contact with the materials should be of the appropriate grade, e.g. food-grade oil.

5.7 Washing and cleaning equipment should be chosen and used such that it cannot be a source of contamination.

5.8 Dedicated equipment should be used where possible when handling and/or processing pharmaceutical starting materials. Where non-dedicated equipment is used, cleaning validation should be performed.