With the expertise that comes with hundreds of cGMP audits performed, Rochem has an accomplished and knowledgeable compliance auditing staff that ensures our represented manufacturers are in compliance with applicable cGMP regulations.
- We audit our manufacturers on a 6- or 12-month audit cycle.
- This auditing program is based on FDA six system quality inspection approach.
- All manufacturers, including pharmaceutical, food and nutritional manufacturers, are expected to maintain or exceed levels of cGMP control.
- Rochem’s audits include an Audit Agenda, Audit Report, and a Corrective Action Report (Major, Minor, Recommendations).
Rochem will not supply from a manufacturer who does not have adequate controls in place to ensure overall product quality.
- Rochem works with FDA inspection teams to coordinate their inspection of our represented manufacturers.
- We attend regulatory agency inspections (FDA, EDQM, etc.) as needed.
- Rochem works with manufacturers to respond to any audit observations in a complete and effective manner.
- We welcome the opportunity to accompany our customers to a sourcing manufacturer.