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Performing your supplier and contractor audits - Developing , Managing and Performing your shared audits - Training and Assessing your auditors - Training your team on GMP ...
More information on assessment audit
Objectives of the audit
- Highlight strengths of your Quality System and potential improvements

- Assess the gap with Cosmetic Good Manufacturing Practices

- Highlight the common points between the Good Manufacturing Practices and ISO 9001 Quality Management System
Preparation of the audit

Prior to the audit, the auditor collects from the customer some documents or information related to the supplier, the manufacturer and products manufactured.
The agenda of the audit to established during this phase before being submitted to the customer and the supplier.

- The scope

- The date of the audit

- The auditor name

- The objectives of the audit

- The audit standard

- The audit timing
Audit on site
The audit on site allows to evaluate GMP compliance related to the :

- Personnel : qualification and training
- Equipment and premises : qualification, cleaning
- Incoming goods : reception, labelling, status, control and storage
- Control of contamination
- Manufacturing and in process controls, process validation
- Intermediates and finished products : storage, labeling and control
- Quality control laboratory : methods, reagents, out of specification results
- Deviation, complaint, recall management
- Supplier management
- Change controls
- Self-inspection
- Documentation

Audit report
At the end of the audit, the auditor presents the strengths, deviations and areas of improvement according to GMP requirements.
These deviations are rating according to European guidelines. The detailed report reflects deviations and observations explained during the closing meeting; The report is issued to the customer within 2 weeks. HCS-QA is in charge to issue the report to the supplier asking for an action plan within one month.
CAPA plan
The action plan is provided to HCS-QA for an evaluation.
HealthCare Services - Quality - Audits
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