Lean GMP Systems

Learn how to design lean, efficient and compliant Quality and GMP-Systems that will support you in turning your quality goals into reality.

Those of us in the competitive and highly regulated pharmaceutical industry understand the need to balance operational efficiency with regulatory compliance. We must find ways to reduce complexities, eliminate redundancies and streamline operations while staying compliant with an array of regulations and guidance documents. Making changes to our quality processes requires overcoming challenges arising from these often competing interests.

However, to face regulatory requirements and expectations, pharmaceutical quality systems have been becoming more and more complex over the past years. In many companies, this has led to a certain inflexibility and inefficiency. But quality related processes, procedures and their related documents should monitor and support, not constrain the true core competence of pharmaceutical companies: the manufacture of cost-effective medicines and APIs at highest quality and in compliance with the regulations.

Quality Managers need to know how to fulfil the regulatory requirements efficiently and how to implement the necessary processes in a lean and cost-effective manner that supports efficacy and safety.