Pharmacovigilance (GVP) audits
PV system, PSMF, and safety-process audits aligned to EU GVP, feeding your audit programme and CAPA.
All practices
GxP Audits & Inspection Readiness
Independent GxP audits and inspection readiness for sponsors, manufacturers, and suppliers. Mock EMA, MHRA, and FDA inspections, supplier and data-integrity audits, and CAPA that holds up, across the EU, UK, and US.
What we do
MRC provides independent, proportionate audits and inspection support across the product lifecycle, from a one-off supplier audit to a standing audit programme.
GCP audits
Investigator sites, clinical databases, the trial master file, and CRO and vendor oversight, across the trial lifecycle.
GLP audits
Good Laboratory Practice audits of non-clinical safety studies, test facilities, and study data, aligned to OECD GLP and 21 CFR Part 58.
More audit types
Supplier and vendor audits
Qualification and ongoing oversight of CMOs, CROs, laboratories, and critical suppliers, remote or on site.
GMP and GDP audits
Manufacturing, packaging, distribution, and supply-chain audits against EU GMP and GDP, the UK regime, and US cGMP.
Internal audit and self-inspection
Independent internal audit programmes and self-inspection that satisfy regulatory expectations.
Data-integrity audits
ALCOA+ reviews of records, systems, and computerised-system controls under 21 CFR Part 11 and EU Annex 11.
For-cause audits
Focused audits in response to a deviation, complaint, signal, or partner concern.
EMA · MHRA · FDA
Inspection readiness
Inspections are scrutiny under time pressure. MRC prepares the people, the documents, and the systems so an inspection becomes a demonstration rather than a defence, whether the authority arrives on site or by remote and hybrid methods.
Mock inspections
A realistic EMA, MHRA, or FDA mock inspection, with front-room and back-room logistics, document requests, and staff interviews.
Inspector-facing preparation
Subject-matter-expert coaching, narrative and storyboard preparation, and management of requests during the inspection.
Findings and 483 responses
Drafting and managing responses to inspection findings, including Form FDA 483 responses, with corrective actions that hold.
Document and sample-pull readiness
Review and remediation of the batch records, trial master file, and documents an inspector asks for first.
From a first inspection to a standing audit programme
We scale support from a single supplier audit or a first inspection through to running audit programmes across multiple sites and regions.
Emerging biotech
Preparing for a first GCP or GMP inspection and standing up an audit programme for the first time.
Manufacturers and sponsors
Running standing supplier, internal, and for-cause audit programmes across sites and regions.
Teams under pressure
Responding to a partner audit, a serious finding, or an imminent health-authority inspection.
Compliant on paper, and defensible under inspection
Hands-on regulatory experience, applied with a compliance-first mindset, keeps a quality system defensible in front of an EMA, MHRA, or FDA inspector. Every audit is planned against the controlling requirement, sized to risk, and reported so that observations are graded, root causes identified, and corrective actions owned.
Mapped
Findings traced to the rule
Every observation cites the GMP chapter, GCP provision, or CFR part it rests on.
Proportionate
Sized to your risk
A single supplier audit, a standing programme, or intensive inspection preparation, scoped to your stage and resources.
Defensible
Built for the inspection ahead
Mock inspections and a findings-response strategy grounded in hands-on audit and inspection experience.
Standards we work to
ICH GCP
ICH E6(R3)
EU GVP
Good Pharmacovigilance Practices
OECD GLP
GLP principles and 21 CFR Part 58
EU GMP/GDP
EudraLex Volume 4, GDP, and US cGMP
Frequently asked questions
What is a GxP audit?
A GxP audit is an independent examination of whether a regulated activity actually follows Good Manufacturing, Clinical, Distribution, or Pharmacovigilance Practice. It tests records, systems, and behaviour against the controlling requirement and reports graded findings with corrective actions.
What is the difference between an audit and an inspection?
An audit is conducted by or for the organisation to give assurance. An inspection is conducted by a health authority such as the EMA, MHRA, or FDA and carries legal consequences. A mock inspection rehearses the inspection using audit techniques, so the real inspection holds no surprises.
How do you prepare for an FDA, EMA, or MHRA inspection?
We run a gap audit against the applicable standard, remediate the highest-risk findings, rehearse with a mock inspection including front-room and back-room logistics, coach the subject-matter experts, and prepare the documents and narratives an inspector asks for first.
What is a Form FDA 483?
A Form FDA 483 lists the inspectional observations issued at the end of an FDA inspection. A timely, credible written response with a corrective and preventive action plan is critical, and we help draft and manage 483 responses so they are complete and trackable.
Do you conduct remote and hybrid audits?
Yes. We conduct supplier, vendor, and internal audits on site, remotely, or as a hybrid, scaled to the risk and the access available, and held to the same evidence standards throughout.
What is a data-integrity (ALCOA+) audit?
A data-integrity audit reviews whether records and computerised systems meet the ALCOA+ principles and the controls under EU Annex 11 and 21 CFR Part 11, covering audit trails, access control, and the full lifecycle of critical data.
How quickly can you audit a supplier or run a mock inspection?
MRC mobilises supplier audits and mock inspections at short notice, scoped to the site, the risk, and the timeline, and reported quickly enough to act before a real inspection.
Reviewed September 2026. Practice lead: Scott McCulloch.
Discuss an audit, a programme, or an upcoming inspection
Whether you need a one-off supplier audit, a standing audit programme, or intensive preparation before an EMA, MHRA, or FDA inspection, tell us where you are and we will come back to you promptly.