On July 18-19, ‘Self-inspection and GMP/GDP Audit’ roundtable was organized at the Agency for Innovative Development of Kaluga Region. More than 40 employees of companies-participants of pharmaceutical cluster took part in the event. Target audience of the workshop was represented by employees of Quality Assurance departments, internal inspectors of various audit types and also managers of structural divisions.
Internal audits are ones of the most efficient and common methods to assess performance of management system. The information obtained in the process of such internal audit serves to review level of compliance of all aspects of company operations with established requirements. In particular, the practical results are: systemic analysis of production risks at all levels of process management, lower number of deviations from production process, standardized same-type processes for different process cycles at the enterprise-wide level.
GMP/GDP requirements, types of audits and inspections, stages, methods and documenting of audits were examined during the workshop. Special attention was paid to the subject of managing competences of internal inspectors and supplier audit.
The participants in the workshop performed practical work in developing questionnaires and assessing deviations and non-compliances. Handout materials were provided to all participants of the roundtable.
According to information from the Agency for Innovative Development – Center for Cluster Development of Kaluga Region.