USP<771>眼膏剂---质量测试章节草案

GMP News
08/09/2016

USP Draft Chapter <771> Ophthalmic Products - Quality Tests

USP<771>眼膏剂---质量测试章节草案

In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a revised draft of general chapter <771> Ophthalmic Products-Quality Tests has been published for comment. The chapter has been previously published for comment in PF 41(5) [Sept.–Oct. 2015] and has become official on May 1, 2016 (USP 39). On the basis of comments received, the USP General Chapters—Dosage Forms Expert Committee is proposing to make the following changes to this chapter:

在USP药典论坛42（4）【2016年6-7月】，USP公布了<771>眼膏剂---质量测试章节征求公众意见，该章节在PF41(5)【2015年9-10月】已经公司，将从2016年5月1日（USP39）生效。在所收到意见的基础上，USP通则---剂型专家委员会提议对此章节进行以下修订：

1. Universal Tests, Identification: If the identification test is nonspecific, at least two orthogonal nonspecific tests should be used.

通用测试，鉴别：如果鉴别测试不具有专属性，至少应使用2个正交非专属测试。

2. Universal Tests, Sterility: The sentence reading, in part, “the immediate containers for ophthalmic products be sealed and tamper proof" is being replaced with a cross-reference to the subsection of the chapter <771> Universal Tests, Container–Closure Integrity.

通用测试，无菌测试：句子“眼膏剂直接接触的容器应密封并有防伪”被替换成对<771>通用测试，容器---密闭器完整性部分的交叉引用。

3. Universal Tests, Leachables and Extractables: Information is being added when the evaluation of Leachables and Extractables is done: This assessment is done in a case-by-case approach during product development and re-evaluated when any changes are made to the product including, but not restricted to, changes in manufacturing process, formulation, and packaging material.

通用测试，可浸出物和可萃出物：在评估可浸出物和可萃出物时增加了此信息。此评估是在药品研发期间各案实施的，如果对产品有任何变更时应进行再评估，变更包括但不仅限于生产工艺、配方和包装材料的变更。

4. Specific Tests, Drop Size: Information is being added that the determination of drop size can be done by any appropriated validated procedure.

特定测试，液滴大小：增加了此信息，液滴大小可以通过适当验证的方法来检测。

Additionally, minor editorial changes have been made to update the chapter to current USP style.

另外，还做了轻微的编辑性变更将该章节更新至现行USP形式。

Comment deadline is September 30, 2016.

征求意见截止日期为2016年9月30日。

Following your free registration on the USP Pharmacopeial Forum website you can read the complete draft of general chapter <771>.

在USP药典论坛免费注册后可以读到<771>的完整章节草案。