Audit readiness Reference https://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Inspection-Readiness-ExecSeries.pdf https://ispe.org/initiatives/regulatory-resources/gmp/audit-checklist# Before start of audit we need to review past audits and note indication of possible problem areas and items, if any ensure that were identified for corrective actions in a previous audit. If not aware about facility learn what products being produced and how it is organised with personal and function. To have systematic audit checklist to be prepared and alongwith notebook it needs to be utilised (notebook required to make detailed entries while audit and checklist is to guide auditor). Atleast three production batches to be selected For thorough analysis to include- a) Traceability of all components or materials used in that batch. b) Documentations of raw materials or components, inprocess and finished goods testing for subject product batches. c) Warehousing and distribution reco...