Pharmaceutical production

Legal and technical requirements for manufacturing companies

A pharmaceutical manufacturer optimized its production processes as part of the expansion of its product portfolio. We supported the quality assurance (QA) and the responsible person (FvP) in the development of the concept with regard to legal and regulatory issues. The aim was to ensure that all requirements of current good manufacturing practice (cGMP) were taken into account when adapting the quality management system (QMS) for specific products. To this end, we also systematically reviewed internal guidelines (standard operating procedures, SOPs) and compared them with official requirements (guidelines and technical interpretations). This strengthened quality awareness and consolidated quality documentation.

Successfully mastering inspections (GxP)

A provider of therapeutic products services contacted Pharmalex GmbH as part of its periodic basic inspection. We supported them in the legal classification of the Swissmedic guidelines and technical interpretation as well as the GMP and GDP requirements of Eudralex Volume 4 of the EU and PIC/S (Pharmaceutical Inspection Co-operation Scheme). This enabled us to jointly harmonize the GMP and GDP requirements with the existing quality management system.

We advise with pragmatic solutions tailored to specific needs.

From A to B via CH

International pharmaceutical distribution

An internationally active pharmaceutical company based in Switzerland handles the Europe-wide distribution of its medicinal products from Switzerland. It was necessary to clarify the conditions under which direct deliveries between EU countries with administrative processing via Switzerland are possible and which authorizations are required for this. All players in the pharmaceutical supply chain must comply with the principles of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) in order to protect patients from falsified medicinal products entering the legal supply chain. With our experience in Swiss and European pharmaceutical law and in matters relating to bilateral agreements (Mutual Recognition Agreement, MRA), we were able to contribute to the design of the distribution structure.