USP Draft Chapter <771> Ophthalmic Products - Quality Tests

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:

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

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.

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.

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

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

Comment deadline is September 30, 2016.

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

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