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.