In response to evolving regulatory expectations, the industry is moving toward integrated, risk-based, and transparent sterility assurance systems for the manufacture of sterile injectable products. CDMOs like GRAM are adapting by embedding continuous improvement, advanced technologies, and lifecycle considerations into their operations.

Jennifer Leale, Director QA & Regulatory Affairs at Grand River Aseptic Manufacturing shares insight on strategies for compliance and validation and evolving regulatory expectations beyond Annex 1.

Contract Pharma: How have compliance and validation expectations evolved based on interpretations from the FDA and other regulatory bodies?

Jennifer Leale: We are seeing regulatory agencies shift from “prove you followed the procedure” to “prove your process is designed and controlled to prevent contamination.” Increasingly, the expectation for manufacturers is to demonstrate process understanding and…