WHO Expert Committee on Specifications for Pharmaceutical Preparations : thirty-seventh report.
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| Superior document: | WHO technical report series, 908 |
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| TeilnehmendeR: | |
| Year of Publication: | 2003 |
| Language: | English |
| Series: | Technical report series (World Health Organization) ;
908. |
| Online Access: | |
| Physical Description: | viii, 145 p. |
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Table of Contents:
- 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 (GMP)
- 7. Quality assurance--inspection
- 8. Quality assurance--distribution and trade-related
- 9. Quality assurance--risk analysis
- 10. Quality assurance--drug supply
- 11. Quality assurance--storage
- 12. International Nonproprietary Names (INNs) Programme
- 13. Miscellaneous
- 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
- Annex 4. Good manufacturing practices for pharmaceutial products: main prinicples
- 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) method to pharmaceuticals
- Annex 8. Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
- Annex 9. Guide to good storage practices for pharmaceuticals.