Effective Risk Assessment in Pharmaceutical: Steps to Ensure a Successful Audit

Effective Risk Assessment in Pharmaceutical

Steps to Ensuring a Successful Audit

Risk Assessment in Pharmaceutical for aseptic manufacturingA risk assessment for pharmaceuticals is the first critical step when designing a contamination control for aseptic manufacturing. Product quality is the critical measure of success.

To ensure product quality, it is imperative that effective particle counting and microbial monitoring is set up for contamination control. The best way to locate sources of viable non viable contamination in your aseptic manufacturing is via a risk assessment, best performed before a process has been implemented.

There are multiple tools to assist in completing a risk assessment, and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted.


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