WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Close this folder11. Pharmaceutical production in developing countries
View the document11.1. Small-scale preparation of ophthalmic (eye) drops
View the document11.2. Production of hormonal contraceptives
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover
 

11.2. Production of hormonal contraceptives

The Committee reviewed preliminary proposals on the production and quality assurance of hormonal contraceptives. Documents had been drafted both because of increasing pressures on several developing countries to manufacture both oral and injectable hormonal contraceptives and because WHO’s Special Programme of Research, Development and Research Training in Human Reproduction was concerned about the quality of certain formulations known to it. The Committee urged that the development of such proposals should take full account of all existing WHO documentation on the quality assurance of pharmaceutical products, and in particular of the revised guidelines on good manufacturing practices (3). The Committee was concerned to avoid any suggestion that the basic principles of quality assurance and good manufacturing practice were not applicable to all pharmaceutical products. It stressed that a proliferation of guidelines dealing with different categories of pharmaceutical products should be avoided. However, to the extent that the manufacture and control of hormonal contraceptives presented particular difficulties, these could be addressed in supplementary guidelines.

Recognizing the substantial manufacturing and analytical problems associated with highly potent, low-dosage combination hormonal contraceptives, the Committee recommended that local manufacture of such products should be discouraged in the absence of well established local programmes of drug regulation and quality assurance. Special care is also required to protect workers and the environment from exposure to hormonal contraceptive agents. The Committee further recommended that national drug authorities should be encouraged to carry out post-marketing surveillance to monitor the continuing safety and effectiveness of hormonal contraceptives.

 

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