Don't Lose Sight Of Ophthalmic Injectables' Regulatory Complexity

Delivering a drug directly into the eye leaves almost no room for error, and regulators know it. Intravitreal injectables sit at the top of the high-risk sterile product category for good reason: the eye's immune response is fundamentally different from the rest of the body, small injection volumes amplify any formulation or purity issues, and the consequences of contamination can be permanent vision loss.

Experts from West Pharmaceutical Services' Technical Customer Support Team recently fielded attendee questions following a webinar on the topic, unpacking where sponsors most commonly underestimate compliance complexity. The conversation centers on EU GMP Annex 1's revised contamination control strategy (CCS) framework, which is now influencing how global agencies are aligning their expectations. Alongside that, USP <1663> and USP <1664> extractables and leachables guidance, USP <788> particulate contamination limits, and demonstrated container closure integrity (CCI) are non-negotiable elements of any submission package.

If your team is early in development or revisiting your packaging strategy, understanding where regulators are drawing new lines is worth your time. Access the full Q&A to get specific on what your compliance roadmap should include.