WH第992号技术报告附录4保存时间研究通用指南.docVIP

WHO第992号技术报告附录4:保存时间研究通用指南，2015 Annex 4 General guidance on hold?time studies Introduction and background 概述和背景 Glossary 术语 3 Scope 范 4. Aspects to be considered 要考虑的方面 Reference 1. Introduction and background 概述和背景 Manufacturers should ensure that the products that they manufacture are safe， effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures. Manufacturing processes should be shown to be capable of consistently manufacturing pharmaceutical products that are of the required quality and that comply with their specifications. 生产商必须保证其生产的产品安全有效，具有其既定用途所需要的质量。应有一 个系统来保证药品足根据经过验证的工艺和既定的程序生产的。生产工艺应具备 持续生产出具有所需的质量，并符合苏质量标准的药品的能力。 Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw materials and packaging materials，intermediate products，bulk and finished products are stored under appropriate conditions. Storage arrangements should not have deleterious effects on the subsequent processing, stability，safety，efficiency or quality of starting materials，intermediate products and bulk products prior to final packing. Maximum acceptable holding periods should therefore be established to ensure that intermediates and bulk product can be held， pending the next processing step，without producing results outside the acceptance criteria for the quality of the material. Normally, intermediate and bulk products should not be stored beyond the established hold time. 优良生产规范（GMP）要求必须做出适当的安排来保证分好的原料、包材、中 间产品、散装产品和包装后的成品存贮在适当的条件下。存贮条件不应对随后的 工艺、稳定性、安全性、有效性或起始原料、中间体产品和包装前的散装产品的 质景产生不良影响。因此应设定最长的可接受保存时间来保证中间体和散装产品 可以在下一工序前的保存不会使得原料质景超出可接受标准。通常，中间体和散 装产品存贮吋间不应超过设定的保存吋间。 The choice of maximum holding period should be supported by relevant data. Studies may extend beyond the chosen maximum but it is not necessary to extend testing to determine the extreme limits at which failure occurs. 最长保存时间的选择