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Audits Experience
BioChem QP Consulting Ltd. Registered Office 272 Bath Street, Glasgow G2 4JR Tel +44 (0)771 897 1245   email enquiries@biochem-qp.com
Auditing Improving compliance at your facility and in your supply chain
The Audit Treadmill? Keeping up with planned schedules for internal, supplier, and contractor audits can be problematic - especially for smaller organisations. For internal audits, a fresh pair of eyes is sometimes required to see the wood for the trees.  For QPs who require to provide confirmation of API GMP, or 3rd Country EU GMP Compliance for IMPs, we can perform these time-consuming audits on your behalf, utilising personal experience gained working in API and IMP production facilities, including steriles and biologicals. We can also help US and other ‘3rd Country’ GMP facilities prepare for EU GMP compliance. Internal Audit / Self Inspection Internal audits should be much more than housekeeping and ‘in-process’ spotchecks. BioChem QP Consulting can bring fresh perspective, and will help you challenge not only whether your procedures are being followed - but whether they are appropriate for today’s requirements in terms of patient protection. We focus on your operational areas - not just the SOP reviews! Supplier Audits BioChem QP Consulting can provide a full range of GMP supplier audits - see panel opposite. With over a decade’s experience of hosting client audits in CMO organisations, as well as performing supplier audits, we know the auditing techniques that give you the most effective returns in understanding supplier quality and building productive relationships. Fully detailed reports are provided within 2 weeks, and we can follow up CAPA plans if required.
Small Molecule API plants
Biological API and Drug Product Manufacturing
Tablet / Capsule Drug Product Manufacturing
Sterile Container Closure Suppliers
Sterile Fill / Finish
Biological Media Suppliers
Packaging Component Suppliers
Excipient Suppliers
Clinical Trial Packaging / Distribution
Ethylene Oxide / Gamma Irradiation Facilities
compliance through science Auditing