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Regulatory & Compliance

Auditing Program

With over 400 GMP audits performed, Rochem has a well experienced compliance auditing staff which ensures that all of our represented manufacturers are in compliance with applicable GMP regulations. Our staff is based in both U.S. as well as China offices.

  • Rochem has internal procedures which are used to perform routine GMP audits of our represented manufacturers. Typically, each manufacturer is audited on a 6 or 12 month audit cycle. This auditing program is based on FDA six system quality inspection approach. While we focus on specific product issues while on site, we also examine, determine, and work to improve the manufacturer’s quality systems using a system based approach.
  • All manufacturers, including pharmaceutical, food and nutritional manufacturers, are expected to maintain comparable levels of GMP control.
  • Rochem’s audits include an Audit Agenda, Audit Report, and a Corrective Action Report (Major, Minor, Recommendations). This CAR is issued at the conclusion of our audit and manufacturers are required to respond in full within 30 days. Based on the result of our audit, manufacturers are classified for acceptability by Rochem. Rochem will not supply from a manufacturer who does not have adequate controls in place to ensure overall product quality.
  • In addition to performing our own internal GMP audits, Rochem welcomes the opportunity to arrange, work with, and accompany an audit by one of our customers of a Rochem represented manufacturer. Rochem provides a GMP trained staff member, fluent in English, to coordinate all audit logistics and accompany the customer auditor during their audit. We work with the manufacturer to ensure that all CAPAs are carried out in a timely manner. Rochem’s compliance staff has well established relationships with FDA compliance officers. Our experienced staff has coordinated and attended over 100 FDA inspections.
  • Rochem works with FDA inspection teams to coordinate their inspection of our represented manufacturers. We also attend regulatory agency inspections (FDA, EDQM, etc) as needed and act as a liaison to ensure inspections proceed as smoothly as possible. Rochem works with manufacturers to respond to any audit observations in a complete and effective manner.