Privatsphäre-Einstellungen

Auditierung und Zertifizierung/Akkreditierung bei der Herstellung von Ausgangsstoffen für die Arzneimittelherstellung

Dr. Heinrich Prinz

PDM-Consulting, Groß-Zimmern

The requirements based on the pharmaceutical regulations have been developed in the last years in such a way that the starting materials have received their own GMP guideline. Therefore, they have to be manufactured according to the GMP regulations and finally to be implemented into the quality management system of the manufacturer of the finished pharmaceuticals.
These starting materials include excipients for use in pharmaceutical products as well as high potency products such as APIs (Active Pharmaceutical Ingredients). The latter are products used as active part in finished pharmaceuticals e. g. tablets or parenterals.
The pharmaceutical manufacturer is obliged to see for oneself for the quality of the starting materials especially for APIs. Most of the time this includes to perform an audit at the production site. It is highly recommended if the producer is not in Europe.
While performing these audits the applicant has to take care about the qualification of the auditors and only qualified auditor will run these audits.
The following publication will focus on the qualification of the auditors against the background of the certification of the company according to EN ISO 17 020 performing these audits based on a contract.