Quality Assurance and Management System

In cGMP, maintenance of quality standards must be responsibility of all the personnel involved in production and control.

The management of a cGMP facility should ensure the presence of a Quality Unit independent of production and that includes Quality assurance and Quality control.

Quality Unit must be responsible for application and maintenance of an appropriate Quality system.

In order to verify that cGMP standards are preserved in the whole system, Quality Assurance performs periodical internal Audits.

All Quality activities and potential deviations from quality procedures need to be registered.

In order to guarantee high quality of the medicinal product, an effective Quality Risk Management System must be in place.

Quality Risks need to be evaluated on scientific bases and process experience.

Quality Assurance must review and approve all Quality documents.

Procelltech operates in compliance with cGMP standards with Quality Assurance Unit reviewing all data before release.

Procelltech, also, offers consultancy for building-up quality management system, quality documentation and staff training on quality topics.