Our Integrated Management System guarantees quality and the highest standards

We have set ourselves the goal of only selling products of high quality, effectiveness and safety in compliance with the legal requirements for environmental protection and occupational safety.

Therefore, we have established a GMP-compliant quality management system, which, in addition to the legal and official requirements for an active ingredient manufacturer, is based on the standard requirements of the international standards DIN EN ISO 9001, DIN EN ISO 14001 and DIN ISO 45001.

The topics of Good Manufacturing Practice (GMP), quality management, environmental protection and occupational safety are combined into an integrated management system (IMS). The IMS is used throughout the company and applies to the synthesis development, production, quality control and distribution of active pharmaceutical ingredients (according to GMP), reference substances and active ingredients for in-vitro diagnostics, medical devices and clinical samples.

The suitability, appropriateness and effectiveness of the existing management system is regularly checked and evaluated.

A process- and system-oriented as well as a risk-based management approach forms the basis for efficient operation and continuous improvement.

The HAPILA GmbH integrated management system serves to achieve corporate goals. In addition to the management manual and a site master file, the IMS is based on a set of master plans, standard operating procedures (SOP) and organizational instructions (ORG) describing all quality-determining processes in the company.

As the person authorized to release the final active ingredients, the Head of QA/QC is consulted on all quality-related matters; additionally, he reviews and approves all quality-related documents. We are regularly audited by our customers and inspected by the competent state authority (Thuringian State Office for Consumer Protection, TLV). The GMP certificates issued for the manufacture of active pharmaceutical ingredients for human medical applications, including active ingredients for use in clinical samples, provide proof of the successful completion of the audits. Moreover, we were successfully inspected by the US regulatory authority (FDA) in 2019.