Auditing
Audits delivered to one method and reported the same way every time.
Supplier, contractor and self-inspection audits for pharmaceutical manufacturers and distributors, led by an GMP Lead Auditor, MHRA-facing, with a microbiologist’s eye for contamination risk.
Auditing
An independent check against EU GMP, graded by risk, with practical help to close what I find.
Consultancy→
I build and remediate the whole system with your team, then hand it over for them to run.
Not sure which? →
A Readiness Review tells you, with a fixed price for what comes next.
Audit types
Supplier and contractor audits
Raw material and component suppliers, contract laboratories, contract manufacturers and service providers, audited against EU GMP and your own requirements.
Self-inspection
An independent self-inspection of your own site against EU GMP. You get graded findings, the requirement behind each one, and practical help to close them.
GDP audits
Wholesale distribution audits against EU and UK GDP, from a named Responsible Person.
Preparing for an MHRA inspection? The Full Readiness Review combines an inspection-style site visit with a prioritised list of what to fix. Mock inspections and supplier qualification programmes are also available.
Who audits
You always know whose name is on the report.
Audits are delivered by named, trained Mozeka associates, working to the same method I use. I choose who does each audit, and I review every report before it is issued.
You are told who carried out your audit. If you are relying on a report to qualify a supplier or release product, you know exactly who looked and who checked.
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Why one method matters
Comparable findings
Every audit follows the same structure, grading and report format. That means you can compare suppliers fairly and track a site from one audit to the next.
Reports you can use
Findings are graded by risk, written in plain language and tied to the requirement behind them. Your supplier knows what to fix, and your quality team can defend the decision either way.
What you receive
01
Audit plan
Scope, agenda and the documents needed, agreed before the visit.
02
Closing meeting
The headline findings on the day, so nothing in the report is a surprise.
03
Written report
Findings graded by risk, in plain language, each tied to the requirement behind it.
04
Help to close findings
Support with root cause, CAPA and the fixes themselves, so findings get closed rather than filed.
Price
Fixed quote for every audit, agreed before you book.
Price depends on the audit type, the site, travel and the reporting you need. Tell me the scope and I will send a quote.
Not for you if
- You want a supplier passed without anyone looking closely. The value of an audit is honest findings.
- You are looking for US FDA audits. My work is focused on UK and EU GMP and GDP.
Need an audit?
Tell me the site, the scope and your deadline, and I will come back with a date and a fixed quote.