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Audit preparation

Prep time frame

Gathering of team

Docs reviewed during preparation

Lead auditor assign tasks

Team configuration

Last audit report

Regular gmp reports

Summary of NCR

What should be archived? Manuscript-Pdf – hard copies

Agenda- supporting documents

Report format

How long reports r kept

Method of archiving

Frequency of audit

Due date 4 sending report

Criteria for follow up

Assessment of CAP

Wrap up report not all inclusive

Narrative section

Reference and method of writing

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