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) sterile products. The review was to focus on an internal deliverable of Continuous Process Verification (CPV) – an important component of the overall quality system of Product Process Validation.

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