Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP<790> Visible Particulates in Injections.

Topical ophthalmic solutions, suspensions, and emulsions are typically packaged in opaque or semi-transparent plastic dropper bottles. This packaging provides resistance to breakage and the controlled drop size needed in ophthalmic container systems. Recent changes to USP <771> Ophthalmic Products-Quality Tests have impacted the particulate and foreign matter testing requirements for ophthalmic products dosed via topical application. The USP <771> chapter instructs that topical products undergo visual inspection for particulate matter as described in USP <790> Visible Particulates in Injections Visual inspection for particulates in the filled unit is not feasible due to the lack of package transparency, and therefore alternative test strategies are needed to evaluate the acceptability of the batch. Aspects of this visual inspection approach include: a statistically based sampling plan for the batch, a destructive testing process, and acceptance limits based on manufacturing process capability supported with benchmark testing of competitor products to confirm manufacturing performance. Overall, the visual inspection program should include: historical trending; process monitoring; and upstream life cycle controls for facilities, raw materials, components, and product contact equipment to meet current regulatory expectations and good manufacturing practices.