Conducting audits according to standardized requirements

Quality management systems require audits to monitor the implementation of requirements and compliance with good practice requirements.

There are several types of audits – audits performed by certification organizations, internal audits and inspections executed by regulatory authorities. The purpose of the audits is to establish compliance and to help the continuous improvement of the quality management system (there are no fines and administrative penalties in these voluntary audits), while inspections are involuntary (pharmaceutical inspections are a necessary condition for issuing a manufacture/wholesaler licence) and they can lead to a temporary suspension of the activity, as well as their results being tied to administrative penalties and monetary fines. In recent years, pharmaceutical inspection standards have included the widespread application of the ISO 9000 series of quality standards.

Sto Solutions EOOD offers both audits and preparation for audits and inspections.