Pharmaceutical manufacturing

Legal and technical requirements for manufacturing companies

A pharmaceutical manufacturer optimised its production processes as part of an expansion of its product portfolio. We supported quality assurance (QA) and the responsible person (FvP) in developing the concept with regard to legal and regulatory issues, ensuring that all product-specific requirements of current good manufacturing practice (cGMP) were taken into account when adapting the quality management system (QMS). For this purpose, we also systematically reviewed internal guidelines (Standard Operating Procedures, SOPs) and compared them with regulatory requirements (guidelines and technical interpretations). This strengthened quality awareness and consolidated quality documentation.