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.