AUDITS + REMEDIATION
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:
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Facilities, including: material / personnel / product / waste flows, cleanrooms and waste handling
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HVAC Systems, including: design, commissioning and cleanroom qualification to ISO 14644 standards
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Clean Utilities, including: Purified Water, Water For Injection, Clean Steam, Clean Compressed Air, Compressed Gases
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Process Equipment, including: All equipment across Drug Substance and Drug Product manufacturing in Biologics, Vaccine, ATMP and OSD
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Cleaning, including: Clean In Place (CIP), Clean Out of Place (COP) and Parts Washers
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Sterilization, including: SIP, SOP, Sterilization Autoclaves, Decontamination Autoclaves and Hydrogen Peroxide Chambers
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.
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Upon prioritization we assist with building remediation plans and support the remediation effort with SME services.
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.
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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.
