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Audit Readiness Program Overview

The audit program document outlines the key steps and activities for an audit, including an opening meeting to discuss company profiles and quality certifications, a plan to visit production facilities and quality control areas, and an examination of documentation such as SOPs, batch documentation, and quality review reports. The audit will conclude with a wrap-up meeting.

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16 views1 page

Audit Readiness Program Overview

The audit program document outlines the key steps and activities for an audit, including an opening meeting to discuss company profiles and quality certifications, a plan to visit production facilities and quality control areas, and an examination of documentation such as SOPs, batch documentation, and quality review reports. The audit will conclude with a wrap-up meeting.

Uploaded by

veerreddy_157808
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

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

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