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Sigma-Aldrich is a global company with sales, manufacturing, and distribution facilities in 34 countries. Many of these locations have quality systems that adhere to the requirements of ISO 9001 and have received third party accreditation. In addition, Sigma-Aldrich has multiple manufacturing locations that are registered with the FDA and operate following current Good Manufacturing Practices (cGMP). Other sites are currently working to enhance their current quality systems that would meet the requirements of a recognized standard.
Internal audit programs have been established at Sigma-Aldrich each location world wide to ensure the integrity and continuous improvement of the Quality Management Systems. Quality audits by our customers are permitted at our facilities. We request that adequate notification be provided (30-days prior to visit) and that an agenda be sent from the customer within 2-weeks of the requested audit date(s). Sigma-Aldrich reserves the right to cancel or revise the audit schedule. Sigma-Aldrich is willing to offer full cooperation to all requests for Government or regulatory audits of our facilities.
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- Validation Master Plans
- Extensive validated documentation
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