Hidden Costs in EM
Why Quality is More Expensive Than You Think
Environmental Monitoring (EM) constitutes a central element of the contamination control strategy in pharmaceutical manufacturing, particularly in aseptic processing. It ensures the microbiological integrity within cleanrooms and controlled environments, which is essential for the production of safe and effective medicinal products.
Increasing regulatory expectations and the complexity of cost-constrained manufacturing make EM not just a compliance obligation but a strategic lever for quality assurance. Minimizing corrective action related expenses and avoiding unnecessary operational overhead requires a clear understanding and mapping of different cost drivers.
This white paper aims to support drug manufacturers in identifying and understanding the hidden costs associated with non-compliance in EM and propose concrete strategies and framework for optimizing quality processes.
Discover insights based on extensive studies and interviews conducted with more than 50 QC managers and technicians.
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