Professional Services for the FDA Regulated Industry

Providing expert consulting services to help FDA regulated health care industries evaluate and/or develop compliant engineering/operations programs such as:
  • Maintenance ProgramMaintaining the Validated State
  • Calibration Program - Maintaining the Validated State
  • Pest Control ProgramProtecting the Product
  • HEPA Filter Testing Program - Preventing Cross-Contamination
  • Replacement Parts Program - Maintaining the Validated State
  • Engineering Contract Service Providers' Qualification - Ensuring the "education, training, experience or some combination thereof" of technicians
  • Project Engineering and Project Engineering Change Control - Merging GEP and GMP
  • etc.

Under the CGMP regulations, equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and mix-ups (§§ 211.63, 211.67, 211.68).  Note that the CGMP regulations require a higher standard for calibration and maintenance than most nonpharmaceutical quality system models. The CGMP regulations place as much emphasis on process equipment as on testing equipment (§§ 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.

FDA Guidance for Industry
Quality Systems Approach to Pharmaceutical CGMP Regulations
September 2006