Identification of Critical Process Parameters, Critical Raw Materials, Critical Components and Critical In-Process Controls for a Group of Sterile Ophthalmic and Otic Products to be Monitored for Continuous Process Verification

XYZ, Inc. is a global pharmaceutical manufacturer of ophthalmic and otic drugs and medical devices. In an effort to align with the FDA’s Guidance for Industry, Process Validation: General Principles and Practices, the firm wished to review several existing (not new)...