CGMP Validation Services

CIP Validation for High-Throughput Nonsterile Line

We validated a complex clean-in-place process for a proprietary nonsterile automation system—designing sampling strategies, acceptance limits, and a custom protocol that passed on the first try.

Temperature Mapping: Warehouse & Controlled Units

We temperature-mapped the client’s full warehouse and all refrigerators, freezers, and incubators—resolving excursion risks and passing FDA inspection with zero observations.

IQ/OQ/PQ for Depyrogenation Oven & Autoclave

We qualified new sterilization equipment with full cycle development, BI testing, and audit-ready documentation—ensuring FDA compliance from day one.

Computer System Validation for Electronic QMS

We led a full CSV project for a 503B’s transition to electronic batch records and deviation tracking—ensuring 21 CFR Part 11 compliance and seamless inspection readiness.