CGMP文件_稳定性试验研究程序SOP.pdf

文件编码 Doc. No.: 标准操作程 颁发日期： 生效日期： 序 Issue Date: Effective Date: Standard 复审日期： Operating 替代： Review Date: Procedure Supersedes: 页码：第 1 页共 13 页 Page No.: 1 of 13 标题：稳定性研究程序 TITLE: PROCEDURE FOR STABILITY STUDIES 1.0 目的 Purpose 制定一个稳定性研究程序，以确定在推荐包装和储存条件下原料药的复验期和制剂的有 效期。 To define a procedure for performing stability study of Drug Substance (API) and Drug Product (DP) for establishing a Re-test date / Expiry date in the recommended pack and storage condition. 2.0 范围 Scope 2.1 此程序适用于公司生产的原料药和制剂的稳定性研究。 This procedure applies to stability studies of Drug Substances and Drug Products. 2.2. 此程序中涵盖了稳定性研究的环境条件、研究周期和检验频率。 This procedure covers environmental conditions, period / frequency of tests for the stability study. 2.3 此程序中也包括恒温恒湿箱出现任何故障时的处理方法。 This procedure also mentions steps to be taken in case of any failures or break downs of the stability chambers. 3.0 定义 Definitions : 3.1 稳定性 Stability: 药物在整个适当的复验期或有效期内，保持它原有的成分，质量和纯度符合既定的 质量标准的程度。 The capacity of a drug substance to remain within established specifications to ensure its identity, quality and purity throughout the retest period or expiration dating period, as appropriate. 3.2 复验日期 Retest Date: 制定人 审核人 批准人 Prepared by Reviewed by Approved by 签名/日期 Sign / Date 名字