Revised USP Chapter <771> Ophthalmic Products - Quality Tests

The revised USP general Chapter <771> OPHTHALMIC PRODUCTS—QUALITY TESTS has been approved and published in USP40-NF35, second supplement, June 1, 2017. The chapter will become official on December 1, 2017.

The draft chapter <771> has been previously published in Pharmacopeial Forum 42(4) [July 2016] and was open for comment until September 30, 2016.

The following changes to this chapter have been made in section DRUG PRODUCT QUALITY:

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 "It is mandatory that the immediate containers for ophthalmic products be sealed and tamper proof so that sterility is ensured at the time of first use." is being replaced with a cross-reference to the subsection of chapter <771> Universal Tests, Container–Closure Integrity (which cross-references to Package Integrity Evaluation—Sterile Products <1207>.

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.

For more Information please visit the USP-NF Homepage.

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