Medical Devices

Medical Devices and Pharmaceutical Products: GDP and GMP

Overview

Good Manufacturing Practice (GMP) is part of quality assurance system for manufacturing medicinal products for human use and active substances.

Good Distribution Practice (GDP) is based on the Guidelines of 5 November 2013 on „Good Distribution Practice of medicinal products for human use” published by the European Commission. They have two main objectives: on the one hand to prevent falsified medicines from entering the legal supply chain, and on the other hand, to ensure control of the distribution chain and consequently maintain the quality and integrity of medicinal products.

Quality Austria offers assessments on both topics. These qualityaustria audits ensure an optimal preparation for any upcoming inspections by National Competent Authorities responsible for the regulation of medicinal products.

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Network partner

Mr. Andreas Aichinger, MSc

Network partner, Product Expert Medical devices ISO 13485

+43 732 34 23 22