Blomberg B, Kitler M E, Milstien J, Dellepiane N, Fanning A, Norval P Y, Spinaci S
Department for Endemic Diseases Control, Prevention and Eradication, Communicable Diseases Cluster, World Health Organization, Geneva, Switzerland.
Int J Tuberc Lung Dis. 1999 Nov;3(11 Suppl 3):S371-80; discussion S381-7.
In efforts to promote the use of fixed-dose combinations (FDCs) for the treatment of tuberculosis (TB), the World Health Organization (WHO) and partners address the issue of quality assurance.
To provide guidance for the development of strategies for quality assurance of FDCs.
This review examines the WHO strategies for and experience with quality assurance and supply of vaccines.
Several elements in the strategies for quality assurance and supply of vaccines may be applicable for FDCs. At national level, the important strategies are to strengthen National Regulatory Authorities (NRA) and procurement systems and develop planning activities. Stressing quality assurance of FDCs in training activities for regulatory personnel and recommending that aid agencies require adherence to quality assurance policies as conditions for support would promote the implementation of quality assurance of FDCs at country level. At the global level, pre-qualification of manufacturers of FDCs should be explored as a mechanism to assure quality. The pre-qualification process should include evaluation of product files, initial testing for compliance and consistency of specifications, and site visits to producers and NRAs. The vaccine model defines criteria for reassessment that can be used for FDCs.
为推动使用固定剂量复方制剂（FDCs）治疗结核病（TB），世界卫生组织（WHO）及合作伙伴着手解决质量保证问题。
为制定FDCs质量保证策略提供指导。
本综述考察了WHO在疫苗质量保证及供应方面的策略与经验。
疫苗质量保证及供应策略中的若干要素可能适用于FDCs。在国家层面，重要策略包括加强国家监管当局（NRA）及采购系统并开展规划活动。在监管人员培训活动中强调FDCs的质量保证，并建议援助机构要求将遵守质量保证政策作为支持条件，这将推动在国家层面实施FDCs的质量保证。在全球层面，应探索对FDCs制造商进行预认证，作为保证质量的一种机制。预认证过程应包括评估产品档案、对规格的合规性和一致性进行初始测试，以及对生产商和NRA进行实地考察。疫苗模式定义了可用于FDCs的重新评估标准。
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