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