NSF Health Sciences, Pharma Biotech
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Rules for Investigating Good Manufacturing Practice (GMP) Deviations in Sterile ProcessingNSF Health Sciences, Pharma Biotech
When things go wrong, there are five non-negotiable processes that should be defined on your deviation investigation standards of practice (SOP): immediate engagement, gemba, triaging using a documented risk assessment, using the Klein process to determine potential root causes, and documenting in real time using an investigation worksheet.
While there are other key requirements, without these processes, it is highly likely that the wrong conclusions will be made, inaccurate root causes will be found, and costly time-consuming corrective and preventative actions (CAPA) will be defined.
Immediate engagement is the logging and triaging of issues within one shift, evidenced by real-time logging. This means that when an issue occurs, trained staff members will notice and be alert to the problem. Their case study based training means they will know how to escalate the problem and investigation begins immediately.
To find out more about investigating GMP deviations download this free whitepaper.