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More information on the audit methodology |
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Audit schedule |
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The customer should submit a request to the manufacturer and introduce HCS-QA as third auditing party. |
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Preparation of the audit |
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Prior to the audit, the auditor collects from the customer some documents or information related to the supplier, the manufacturer and products manufactured. |
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The agenda of the audit is established during this phase before being submitted to the customer and the supplier. |
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Audit on site |
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The audit on site allows to evaluate GMP related to : |
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- Personnel : qualification and training
- Equipment and premises : qualification, cleaning
- Incoming goods : reception, labelling, status, control and storage
- 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 |
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Additionally, specific costomer items are considered during the audit |
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Audit report |
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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. In case of critical deviations, information is submitted to the customer within 48 hours. 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. |
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Evaluation of CAPA plan |
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The action plan is evaluated by HCS-QA auditor before being issued to the customer. |
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Follow-up audit |
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On customer request, HCS-QA is able to perform the follow-up of actions with the supplier. |
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HealthCare Services - Quality - Audits
1 rue Paul Séjourné - 75006 Paris - mckrief@hcs-home.com - Tél : +33 (0)6 09 64 68 21 |