AUDITS + REMEDIATION
AUDITS + REMEDIATION
STRATEGIC AUDITS
We have expertise in GMP design review, 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, cleanroom design, and waste handling, ensuring alignment with Annex 1 contamination control strategies for maintaining a sterile environment.
HVAC Systems:
Including: design, commissioning, and cleanroom qualification to ISO 14644 standards, which supports pharmaceutical quality systems compliance.
Including: Purified Water, Water For Injection, Clean Steam, Clean Compressed Air, and Compressed Gases, critical to maintaining quality in the pharmaceutical industry and meeting pharmaceutical quality management system requirements.
Process Equipment:
Including: All equipment across Drug Substance and Drug Product manufacturing in Biologics, Vaccine, ATMP, and OSD, ensuring robust compliance remediation plans for any identified gaps in pharmaceutical quality systems.
Cleaning:
Including: Clean In Place (CIP), Clean Out of Place (COP), and Parts Washers, designed as part of contamination control strategies for sterile manufacturing training initiatives.
Sterilization:
Including: SIP, SOP, Sterilization Autoclaves, Decontamination Autoclaves, and Hydrogen Peroxide Chambers, essential for facilities aiming to maintain quality compliance in the pharmaceutical industry.
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.
