(1993; 36 pages)
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.