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Audit

We will prepare you.
The cornerstone for efficient inspection has been laid with "risk-based-approach" and "PAT-guideline" by the FDA. But what exactly does the risk based approach mean for you and how to implement it?

We'll give you the answers and show you how to perfectly measure the inspection efforts and sustainably maintain an efficient risk management in your company.

Our experienced staff will support you in preparation and implementation of audits. Using a structured survey, we uncover shortcomings in complying of applicable guidelines, standards and current recommendations. Furthermore, we support your department for Quality Assurance in the sectors qualification and calibration. We design or review your GMP-documentation on site as part of your Quality Assurance Team.

To let you speed up your pace, we can serve as your representatives, we carry out GMP-audits and we advise you individually on current issues.

Supplier Audits
Dohm Pharmaceutical Engineering performs supplier audits at your request. We check on ingoing shipments as well as on organization and documentation of the production of machinery with regard to GMP-conformity. Audit-planning is being carried out by our experienced auditors. They are the ones to perform the on-site audit. Subsequently, you are being provided with our detailed audit-report for your documentation.