Vendor Audit Services
The FDA is becoming more aggressive in tracking quality issues, which reflects an increasing need for more traceability in the drug manufacturing supply chain.
No single company can physically audit every supplier but, because SAFC routinely audits numerous companies in the course of its business, we can expand your compliance reach.
SAFC now offers a complete package of audit services.
Using our professional team of global auditors, SAFC can help you ensure proven quality in your own supply chain by facilitating the vendor audit process, for key intermediates and starting raw materials.
Why Outsource Your Audits?
Expand your audit reach – without expanding your regulatory compliance staff
Reduce your audit costs – with SAFC’s economical approach, more competitive than many internal and external audit programs.
For greater economies of scale, ask about the vendor audit results sharing option.
Rely on SAFC's Experienced Resources – with our network of professional auditors around the globe, experienced in US /EU quality standards and the FDA audit process
Why SAFC?
Confidence and convenience – Financially stable, global with operations in over 36 countries, SAFC can remove traveling, translation and reliability issues from the vendor auditing process and provide you with timely dependable results.
Deep understanding of audit requirements - SAFC has a network of over 10,000 suppliers, 34 manufacturing facilities (including 9 cGMP sites) and we’ve built our experience at our own facilities or our vendors' sites.
Annually, we host more than 100 audits within our own manufacturing facilities and perform over 100 audits per year with our vendors. By extending our audit expertise to our customers, SAFC aims to build a shared resource where audit reports and vendor quality information can be easily attainable.
Audit Deliverables
SAFC audits are performed by a team of compliance professionals and all audits are followed by a preliminary report, delivered in a timely fashion, using a report format that has been adapted to the customer requirements. |
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Initial audit findings available within seven business days |
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Final report provided within 30 days |
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Audits can vary from 1 to 5 days, whether they are Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) |
| Typical list of audits include reviews for: |
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Quality systems |
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Process quality |
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Product quality |
| Standard audits available include: |
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ISO 9001:2008 (previously ISO 9001:2000) |
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ISO 13485:2003 |
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21 CFR 211 |
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21 CFR 820 |
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ICH Q7A |
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21 CFR 211 |
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GAMP 5 |
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GLP |
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21CFR58 |
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SAFC can also perform audits to customer specifications upon request.
Pricing
Competitive prices, special pricing options will be discussed with customers willing to allow SAFC to reuse audit information for other customers.
Full confidentiality of customer-specific information will be preserved.
| Audit price per day: $2000* |
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GLP Audit = average 2.5 days |
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ISO Audit = 3.5 days |
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cGMP Audit = 4.5 days |
Discounts of 25% off standard list price are offered to those customers willing to share the results of audit in a Sigma Aldrich database.
Audits done previously by Sigma Aldrich may be available and purchased according to the price schedule below.
| GLP Audit Pricing |
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Less than 1 year (70% of original cost) = $2,625 |
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Less than 2 years (50% of original cost) = $1,825 |
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Less than 3 year (30% of original cost) = $1,125 |
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| ISO Audit Pricing |
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Less than 1 year (70% of original cost) = $3,675 |
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Less than 2 years (50% of original cost) = $2,625 |
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Less than 3 year (30% of original cost) = $1,575 |
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| cGMP Audit Pricing |
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Less than 1 year (70% of original cost) = $4,725 |
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Less than 2 years (50% of original cost) = $3,375 |
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Less than 3 year (30% of original cost) = $2,025 |
* price does not include travel expenses nor extraordinary costs that may be incidental to base cost of conducting audit.
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