Quality Assurance Systems
At Wickham Laboratories, we have strong focus on quality assurance, with regular audits from the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) to ensure our continuous GMP and GLP compliance.
Key to our success is our total commitment to providing a quality testing service, combining high levels of client satisfaction together with the maintenance of appropriate accreditation. To enable us to meet such demanding ambitions, we operate an independent Quality Assurance Unit (QAU) to oversee all our test facility related activities.
To ensure complete control of all of our testing activities, our Quality Assurance Unit details four main functions:
- Study plan checks for GLP compliant work
- Procedural inspections
- Report reviews
- Facility inspection and audits
In addition to these core functions, the Quality Assurance Unit oversees:
- Supplier and sub-contractor qualification
- SOP & quality manual maintenance
- Maintaining change controls
- Test report inspection
- Review of the quality system
Our quality system is in a constant state of evolution as methods and test procedures are updated, and both regulatory and client inspection recommendations are instituted as a matter of course. We maintain an audit ready facility at all times and regularly receive positive feedback during the auditing process from our clients, industry peers and regulatory authorities. Consequently, we are proud of how our services are recognised in the industry and our ability to deliver consistent, high quality testing no matter what the laboratory discipline.
Summary of Accreditations
The Company is assessed under the United Kingdom Good Laboratory Practice (GLP) Compliance Programme in alignment with the Organisation for Economic Co-operation and Development principles.
The MHRA and the FDA inspect our facilities and quality systems for compliance with the principles and guidelines of Good Manufacturing Practice (GMP) with respect to contract analysis of Human Medicinal and Veterinary Medicinal products.