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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 the audit methodology
Audit schedule
The customer should submit a request to the manufacturer and introduce HCS-QA as third auditing party.
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 is established during this phase before being submitted to the customer and the supplier.
Audit on site
The audit on site allows to evaluate GMP compliance related to the :
- Personnel : qualification and training
- Equipment and premises, cleaning
- Control of contamination
- Incoming goods : reception, labeling, status, control and storage
- Manufacturing and in process controls
- Intermediates and finished products : storage, labeling and control
- Quality control laboratory : methods, reagents, out of specification results
- Deviation, complaint, recall management
- Change controls
- Self-inspection
- Documentation
Additionally, specific costomer items are considered during the audit
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.
Follow-up audit
On customer request, HCS-QA is able to perform the follow-up of actions with the supplier.
HealthCare Services - Quality - Audits
1 rue Paul Séjourné - 75006 Paris - - Tél : +33 (0)6 09 64 68 21