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For more information, see: Compliance Group mandate - joint audit programme for EEA GMP Inspectorates; The audit programme, its procedures and templates below form the complete set of documents used in the JAP.
Added an anonymised raw data set, so that stakeholders can do their own tailored.
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Therefore, ISPE and the GMP Institute accept no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist. Use iAuditor's scoring feature to evaluate the overall performance of the processes and track improvements. Sample Mock FDA Audit & Gap Analysis Agenda *Assumes consultant has already reviewed firm's SOP index, critical SOPs and any auditor prep package.
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