RISK ASSESSMENT PROTOCAL FOR STERILE FORMULATION FACILITY
A risk assessment is a method to assess and characterise the critical parameters in the functionality of a System or process. Therefore, risk Assessment is a key element in the process and validation approach. In the Area modification, risk analyses are performed as basic GMP/EHS-Risk Assessment, which shall help to identify important GMP/EHS-requirements.
The Risk Assessment report is produced to provided documented evidence that design concepts or requirement are complete in considering all GMP, EHS and operational risk. The objective of this protocol provide a document evidences for Area modification which happen.
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