Audits We Provide
Clarion Quality offers a comprehensive range of audit services for pharmaceutical, laboratory, and manufacturing clients throughout the UK. Our auditors hold LRQA & JEMO ISO 9001 Lead Assessor, PS 9000 Lead Assessor, and UKAS ISO17025 Lead Assessor certifications, ensuring you are supported by highly qualified professionals at every stage.
Gap Analyses and Benchmarking
We undertake detailed gap analyses to compare your existing processes against current regulatory requirements and industry best practice. Clarion Quality benchmarks your systems, highlighting opportunities for improvement and providing supporting recommendations to close compliance gaps efficiently.
QMS Revision
Revision of your Quality Management System (QMS) is essential for continued compliance and business improvement. Our auditors thoroughly assess your QMS documentation, process controls, and record-keeping structures. We ensure alignment with key standards, such as ISO 9001:2026 and ISO/IEC 17025, while recommending practical changes to streamline processes and mitigate risk.
Training Across Your Organisation
Education is vital for sustaining quality culture. At Clarion Quality, we deliver tailored training for staff at all levels to embed regulatory awareness and strengthen quality systems. Our helpful support ranges from induction modules to advanced compliance workshops, designed for your business needs and staff roles.
Our audit services extend to every aspect of your operations, giving you reassurance that your organisation will pass regulatory inspections, meet pharmaceutical supplier qualification requirements, and maintain a robust and compliant environment. Industries we support include pharmaceuticals, laboratories, manufacturers, and clinical trial organisations.
Good Manufacturing Practice Audits
Clarion Quality's GMP site inspections are led by qualified GMP Lead Auditors, combining over 10 years as cGMP Quality Managers with 25 years of international supplier auditing experience. We are trusted partners to pharmaceutical companies seeking robust Good Manufacturing Practice compliance in the UK and beyond.
Site Inspections
Our audits provide a structured assessment of your facility, reviewing procedures, equipment, documentation, and hygiene practices to ensure your site complies with GMP regulations. Site inspections are conducted discreetly and professionally, minimising disruption while delivering clear, actionable feedback.
Supplier Audits
Supplier qualification is a regulatory requirement for pharmaceutical manufacturers. Clarion Quality's pharmaceutical supplier qualification audits provide thorough checks on your critical suppliers' quality standards, ensuring your supply chain remains compliant, risk-resilient, and ethically sound.
Pre-Contract Placement Inspections for GMP
Before new supplier contracts are signed, our pre-contract inspections validate each supplier's GMP and quality systems, safeguarding your product integrity and organisation reputation.
Clinical Trial Importation Hubs and Surveillance Audits
Clarion Quality provides clinical trial audit services for importation hubs, ensuring that procedures, warehousing, and logistics adhere to GCP and GMP standards. We also offer ongoing surveillance audits to monitor compliance between formal regulatory inspections, supporting continuous improvement through regular, constructive assessment.
In every instance, our audit process is designed to be transparent and supportive. We collaborate closely with your team, explaining findings and guiding corrective actions, to help your organisation uphold regulatory compliance and quality commitment.
Frequently Asked Questions
What types of GMP audits does Clarion Quality provide?
Clarion Quality offers GMP audits, including site inspections, supplier audits, pre-contract placement inspections, and surveillance audits across the UK.
What is included in a pharmaceutical supplier audit?
A pharmaceutical supplier audit checks your supplier’s GMP compliance, quality systems, record-keeping, and risk management to ensure reliable supply chains.
How does a gap analysis audit work?
A gap analysis audit compares your current practices against regulatory and industry standards, identifying areas to improve compliance and recommending action.
How can an audit help prepare for regulatory inspections?
A Clarion Quality audit uncovers compliance gaps and offers actionable feedback so organisations can meet regulatory expectations and be ready for inspections.
Do you conduct audits for clinical trial facilities?
Yes, we provide clinical trial audit services, including audits of importation hubs and related logistics, ensuring GCP and GMP compliance for clinical trial facilities.
What should organisations expect during a GMP audit?
During a GMP audit, Clarion Quality's auditors review procedures, documentation, and practices, offering transparent, supportive guidance and follow-up recommendations.
Arrange an Audit for Your Site
To discuss how Clarion Quality can support your pharmaceutical site audits, GMP inspections, or supplier qualifications in the UK, please contact us as our helpful team is ready to assist.
Services
Clarion Quality GXP UK Limited - Company number 12675976 - Registered in England & Wales