Environmental Monitoring in Drug Product (EMinDP)

Environmental monitoring (EM) is a fundamental control for the biopharmaceutical industry yet available guidance is quite general and open to significantly differing interpretation. This makes the full justification of sampling plans challenging in the face of regulatory scrutiny and it difficult for organizations to optimize and harmonize controls across plants and networks. Using the heightened requirements in and around grade A areas, a group of industry subject matter experts have written this highly detailed best practice guidance on EM risks assessments and sample location and method planning, to provide clarity on how to monitor and control our manufacturing environments. This is the first such detailed standard and will be the basis for consistent application of current best practice; thereby minimizing the risk of regulatory scrutiny and non-compliance, supporting business continuity while reducing unnecessary monitoring to a minimum