Process Validation & Support

Validation is the scientific proof of quality consistency. QualyInc helps write validation master plans, execute cleanroom studies, and prepare GAMP 5 computer validation records.

We support Hyderabad formulation facilities in validation stages, covering media fills, HVAC filter integrity testing (DOP), heat distribution profiles for sterilizers, and toxicological limits for multi-product cleaning runs.

Key Deliverables

• Validation Master Plan (VMP): Drafting facility-wide validation schedules in compliance with regulatory expectations.
• Equipment Qualification Protocols: Generating IQ/OQ/PQ protocols for autoclaves, vial washers, freeze dryers, and tableting machines.
• CSV Validation: Performing Software Qualifications for laboratory LIMS and warehouse automation setups under GAMP 5 principles.

Need a customized scope proposal?

Our consulting team is based locally in Hyderabad and can perform a baseline visit within 48 hours.

Request a Custom Proposal