QUALITY

ISO 9001

ISO 9001 expresses internationally valid requirements for the management system of a company, particularly with respect to the quality of production, service provision and development. Working by this standard is a matter of course for PANATecs. Aside from the audits from the certification society, PANATecs performs regular internal audits. By using monitored processes, PANATecs ensures that a constant high quality is maintained within the company and strives to continuously improve customer satisfaction and company organization. PANATecs offers customers the possibility of checking the high quality standard by performing supply audits. It is a matter of course for PANATecs that the QM system should be both efficient and pragmatic, closely orientated to the customer.

This combination is what makes PANATecs a successful and efficient outsourcing partner for customers from the pharmaceutical and biotechnology industries for whom quality and performance are decisive.

Good Manufacturing Practice (GMP)

In addition, PANATecs has been awarded manufacturing authorization for test laboratories in accordance with §13 of the Medicines Act. PANATecs is the first test laboratory specializing in protein analysis which has achieved GMP status, together with the manufacturing authorization for test laboratories in accordance with the 15th Amendment to the Medicines Act. PANATecs
performs analysis related to release in the responsibility of the “Qualified Person” (QP).

As outsourcing partner, PANATecs then assumes the responsibility under drug law for the commissioned tests and thus reduces the customer’s load of work.

ICH Directive

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) harmonizes the evaluation criteria for human medicines as a basis for the approval of medicines in Europe, the USA and Japan.