For several years, the WHO Regional Office for the Eastern Mediterranean has fostered an initiative for regional self-sufficiency in vaccine production. A key to the success of this initiative is to improve confidence in the quality of vaccines. In order to achieve this, a practical quality assurance system must be in place for vaccines, which can ideally be extended to cover other biological and biotechnology-derived products. A regional plan of action was therefore formulated during a meeting in Islamabad, Pakistan in July 1995, covering the following elements:
1. Establishment of a national control authority.
2. Promotion of quality assurance at national and regional level.
3. Development of an efficient system for the registration of biologicals.
4. Development of a legal framework to support the quality assurance system.
5. Development of a national inspection system.
6. Establishment of access to biological quality control testing facilities.
7. Development of a quality assurance system at nation production facilities.
8. Establishment of quality assurance within the biologicals supply system.
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