General Statement
 SAFC has optimized the Quality Management, Quality Assurance, and Regulatory Affairs organizations in order to consistently meet the Quality and Regulatory requirements of our customers (both internal and external).
Within this organization, individuals assigned to the functional Quality Management Team have been explicitly identified along with the sites they will support. This functional support will insure there is a mechanism for top-down, and bottom-up communication of Corporate Quality guidelines and policies. It also facilitates the Corporate Quality auditing process of all the various SAFC sites.
Organization & Reporting Structures:
Within SAFC, the global Quality Management structure is responsible for overall leadership of the Quality Management and Regulatory Affairs functions. This includes developing strategies and policies for meeting current industry, customer, and business requirements, as well as insuring that proper resources are allocated to the Quality Management System.
- SAFC Corporate Quality Policies are developed at a corporate level, by the functional Quality Management Team described above, and then implemented at each of the Quality Units at each site.
- The Quality Units at each site are independent of production and report up through the overall Quality organization.
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Quality Responsibilities
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Qualification and validation activities |
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Control of documents |
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Batch record review |
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Product release |
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Investigation of nonconformances |
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risk assessment |
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Implementation of corrective and preventive actions |
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Change control and customer notifications |
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Training |
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Internal, customer and regulatory audits |
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Supplier qualification and audits |
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Regulatory review of APIs and cGMP manufactured products |
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Review and approval of final and raw material product specifications |
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Review and approval of all manufacturing and packaging documents and operating procedures |
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Quality Control Responsibilities
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Method development, and method validation of assays |
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Writing and approving quality control procedures and protocols |
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Sampling and testing of raw materials and intermediates |
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Chemical, physical, biological, and microbiological testing of final products and API’s. |
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Investigation of out of specs for laboratory trending and CAPA |
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Stability testing and management of ICH stability program |
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