European Parliament Library

WHO Expert Committee on Specifications for Pharmaceutical Preparations, thirty-seventh report

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guideli
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 principles -- 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
Literary Form
non fiction
1st ed.
Description based upon print version of record
Physical Description
1 online resource (145 p.)
Specific Material Designation
Form Of Item

Library Locations

  • EP Library Brussels

    60 rue Wiertz, Brussels, B-1047, BE
  • EP Library Luxembourg

    Rue du Fort Thüngen, Luxembourg, L-1313, LU
  • EP Library Strasbourg

    7 Place Adrien Zeller, Allée du Printemps, Strasbourg, F-67070, FR