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AUDIT PROGRAM

1. OPENING MEETING:
Agenda agreement General company presentation and profiles, flow chart GMP and other quality certifications / Site Master File Warehouse (raw material and finish product) Production facilities Water plant Quality control (analytical and microbiology control)

2. PLAN VISIT:

3. DOCUMENTS EXAMINATION:

SOP Management of documentation SOP Training, training program and job description SOP validation, validation master plan and example of validation of a room SOP cleaning SOP calibration SOP self inspections, plan and questionnaires SOP complains SOP deviations and CAPA SOP out of specification SOP change control SOP supplier evaluation SOP pest control SOP sampling and dispensing SOP Standards management SOP retention samples SOP stability and results SOP sanitization of drains SOP reworks and reprocessing SOP water plan and control results SOP of traceability SOP of recall SOP of returns SOP of complaints SOP handling of packaging Batch documentation (CoA, CoM, etc) APQR (annual product quality review) Etc

During the visit it can be requested additional documentation.

4. WRAP UP MEETING