Quality management systems that hold up under inspection

Manufacturers, importers and distributors of medicinal products and active substances, with a focus on quality control laboratories. Since 2019 I have provided audit and consulting services on an ongoing basis to a number of clients, which is the kind of arrangement this work suits best.

The work itself

Establishing a quality management system

For a company setting one up for the first time, or rebuilding one that has grown out of shape. Procedures written to be followed rather than filed, a document hierarchy people can navigate, and defined responsibilities that match how the company actually operates.

Maintaining an existing system

Ongoing support rather than a report handed over and forgotten: procedures reviewed and updated against current GDP, pharmacovigilance and corporate standards, deviations and change controls assessed, self-inspection programmes planned and run.

Quality control laboratories

The area I know best. Method validation, transfer and verification, out of specification handling, stability programmes, data integrity in laboratory records and computerised systems.

Support during inspections

Preparation before a national authority inspection or a customer audit, presence during it, and help with responses and the corrective action plan afterwards. I have been on the receiving side of inspections by Polish, Russian and other authorities, and that is what this support draws on.

Records an inspector can trust

Data integrity is not a separate service here, it runs through everything. Audit trails that exist and are reviewed, access rights that match the roles, spreadsheets used for quality decisions that have been validated, manual entries with a second pair of eyes.

These are the findings that turn into serious problems during an inspection, and they are the ones companies most often discover too late. I look for them as a matter of course, in audits and in consulting alike.

Arrangements

Two shapes, depending on what you need. A defined project with a scope and an end date, such as building a system or preparing for an inspection. Or an ongoing arrangement, an agreed amount of time each month, for a company that needs quality expertise without a full time hire.

Every engagement is quoted individually against its scope. There is no price list, because the work differs too much from one company to the next for one to mean anything.