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| Pharmaceutical services : Audits |
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Supplier audits of actives substances or excipients for pharmaceutical industries |
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| Good knowledge of suppliers is a key element to guarantee the product quality provided to the patient. Quality questionnaire or reports provided by suppliers is not always enough to qualify a supplier. |
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- You don’t have enough internal resources ?
- You are not able to fulfill your audits plan due to unplanned issues ?
- You need expertise to audit your supplier prior to reduce testing of incoming goods ? |
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| From your audit plan, HCS-QA has expertises to perform your supplier audits. |
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| More information on audit methodology… |
| More information on auditor qualification… |
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Qualification of suppliers /contractors |
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- You need to qualify a new contractor ?
- You plan to qualify a new supplier ?
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You need to guarantee the supply chain of your materials ?
- You need to select one supplier among others for a specific project ? |
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| HCS-QA is able to support your team to set up reducing lesting plan, from the quality agreement to the control of the supply chain. |
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Set-up Raw Materials reducing testing |
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- Reduce testing at raw materials reception ? It is permitted only under certain conditions.
- You plan to set-up a Quality Agreement with your supplier ?
- You need a Quality Control expert to audit the QC lab of your supplier ?
- You need to control your incoming goods supply chain ? |
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| HCS-QA is able to support your team to set up reducing lesting plan, from the quality agreement to the control of the supply chain. |
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Shared audits |
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| Pharmaceutical industries have to perform many supplier audits. This situation could cause problematic issues for all parties : |
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- Pharmaceutical companies should optimize their costs
- Some suppliers reject audits due to the number of audit requests
- The volume of materials supplied is too low |
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HCS-QA is able to organize shared audits on behalf of several pharmaceutical companies. Share your list of suppliers to be audited, HCS-QA will come back to you in case of potential shared audits.
HCS-QA shares with you the list of shared audits planned on a monthly bases. |
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Audits of distributors |
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Manufacturing of raw materials and medicines are under control. Is it enough to ensure the quality of the medicines for patients ?
Supply chain is very complex with a lot of actors involved : |
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- From the raw materials to the manufacturing sites
- From the medicine release to the patient |
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Only the knowledge and the check of Good Distribution Practices (GDP implementation) allow the control of the pharmaceutical supply chain and ensure Quality, Effectiveness and Safety of Medicines to patients.
The aim is to better control the distribution chain, and to face the threats of parallel trade and counterfeiting. The application of these Good Distribution Practices requires: |
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- Adequate capacity: Staff, Premises, Equipment, Transport
- Clear procedures and instructions
- Qualified and trained personnel
- Reliable documentation system to ensure the overall monitoring of the distribution |
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| HCS- QA is able to support your staff in a better understanding of your supply chain by auditing the whole actors. |
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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 |
