GxP: Documented Quality
Pharmaceutical quality management systems extend from the development of a medicinal product all the way to its use by the patient. At every step along the way, quality assurance measures have been established and codified as “Good Practice”.
These include, among others, the GMP guidelines for manufacturing (Good Manufacturing Practice), which were first published by the WHO in 1968 and have since been continuously developed. The GMP rules applicable within the European Union are published in the EU GMP Guidelines. Similar EU guidelines also exist for the wholesale distribution of medicinal products (Good Distribution Practice, GDP) and for the ongoing monitoring of drug safety (Good Pharmacovigilance Practice, GVP).
Ensuring that these GxP standards are effectively implemented within a company is the responsibility of key personnel such as the Qualified Person (QP), the Qualified Person for Pharmacovigilance (QPPV — known in Germany as the Stufenplanbeauftragter), or the Responsible Person for Wholesale Distribution (RP).
Diapharm supports pharmaceutical companies and their responsible function holders in efficiently integrating these requirements into their internal quality management systems, maintaining compliance with GxP standards, and demonstrating this compliance to regulatory authorities during inspections. Diapharm designs GxP-compliant quality management systems, defines quality assurance requirements, and assists companies in obtaining the necessary authorizations.
QP, QPPV, VP: Diapharm assumes responsibility
