Audits

GMP, GDP and GVP supplier audits

You carry the responsibility for your suppliers whether or not you have the people to go and look at them. I go instead, and I write what an inspector would expect to read.

Types of audit

Four reasons companies call me

Supplier qualification and requalification

A new supplier before the first delivery, or an existing one whose audit is due. The audit answers one question: can this supplier be relied on for the material or service you buy from them, and can you show why you concluded that.

For-cause audit

After a complaint, an out of specification result, a recall or a signal from the market. Narrow scope, fast start, focused on the cause and on what the supplier has done about it.

Gap assessment before an inspection

A review of your own system against what an inspector will look at, with the findings listed in the order they need fixing. Useful when a national authority inspection or a customer audit is coming and you want to know now what would be written up.

Programme of audits over a year

An agreed number of supplier audits planned and carried out across the year, so the qualification schedule stops being a rush every December.

Scope

Who I audit

EU GMP · EU GDP · EU GVP · ISO 9001 · ISO 17025 · ISO 13485 · ISO 15378

How it runs

From the first call to audit closure

You tell me the site, the scope and the date you need the report. I confirm whether I can take it, what it involves and what it costs. Every audit is quoted individually, because the scope, the travel and the number of days differ every time.

Before the audit I review what you already hold on the supplier: previous reports, open findings, quality agreements, complaints. The audit plan goes to the supplier in advance, so the right people are in the room on the day.

On site I audit the system, not the people running it. Every finding is presented at the closing meeting, with the evidence and the requirement behind it, so the supplier knows where they stand before I leave. Nothing in the report that reaches you later is news to them.

The report is written in English, to the date agreed before the audit started. Findings are classified and each one carries the evidence and the requirement it fails against.

The audit does not end there. I answer your questions on the findings, review the CAPA plan the supplier proposes, monitor implementation and close the audit.

On site, remote, hybrid

Where the audit takes place

Most audits are on site. I travel worldwide and I audit regularly in Asia, where a large part of the supply base sits.

A remote audit is a reasonable choice for a low risk supplier, for a requalification where nothing material has changed, or where travel would delay the qualification past the point of usefulness. A hybrid audit splits the two: documentation reviewed remotely, the site walk and the interviews done in person, which shortens the days on site without giving up what only being there shows.

Which of the three fits your case is part of the first conversation, not something decided for you.

Contact

Ask about an audit

Describe the site and the scope in a few sentences, and I will tell you whether I can take it, when, and what it involves.