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FACILITY AUDITS

STRATEGIC AUDITS

We have expertise in Design, Construction, Qualification and Operation of pharmaceutical facilities and use this expert knowledge to perform targeted GMP audits of:

  • Facilities, including: material / personnel / product / waste flows, cleanrooms and waste handling

  • HVAC Systems, including: design, commissioning and cleanroom qualification to ISO 14644 standards

  • Clean Utilities, including: Purified Water, Water For Injection, Clean Steam, Clean Compressed Air, Compressed Gases

  • Process Equipment, including: All equipment across Drug Substance and Drug Product manufacturing in Biologics, Vaccine, ATMP and OSD

  • Cleaning, including: Clean In Place (CIP), Clean Out of Place (COP) and Parts Washers

  • Sterilization, including: SIP, SOP, Sterilization Autoclaves, Decontamination Autoclaves and Hydrogen Peroxide Chambers

  • Calibration and Maintenance.

 

We work in collaboration with your onsite team and have developed a structured approach to quickly identify and risk rank compliance risks and provide remediation recommendations. These audits can be performed either remotely or on site and generally take 3-4 days between audit planning, preparation, execution and reporting.

GMP Self Inspection

If you are interested in performing a GMP self inspection we have created this useful Good Manufacturing Practice (GMP) risk assessment to allow pharmaceutical manufacturers to perform self-assessments on their facility and quality systems in accordance with ICH Q7.

The output from the risk assessment is shown on an interactive dashboard where you can see the distribution of risk, assign action items and track actions to closure.

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