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SAFC Biological Buffers Quality System Before and After Implementation of the Controlled Quality System Many of SAFC's customers, who purchase buffer products, have the expectation of SAFC to utilize a quality system that manages and evaluates change as well as showing evidence of controlled, consistent processes. In 2005, SAFC made the decision to elevate the quality level of its buffers' manufacturing facility in St. Louis. The upgraded quality system is modeled on elements of ICHQ7A, a global GMP guideline for Active Pharmaceutical Ingredients (API's) for the pharmaceutical industry. Because many of SAFC's buffers are used in the pharmaceutical and diagnostics manufacturing industries, the choice of this quality standard made good sense. >> Questions? Inquiries? Contact a SAFC Supply Solutions Representative >> Return to Enhanced Quality Profile Program Section See how these Q7A Elements have Improved:    Quality Management    Personnel    Buildings & Facilities    Documentation & Records    Materials Management    Production & Process Controls      Laboratory Controls    Validation    Change Control    Rejections & Re-Use of Materials    Contract Manufacturers (Suppliers)       Q7A Element - "Quality Management" Before Implementation of the Elite Quality System       Critical parameters were not identified or controlled     No formal systems for:             - Investigations of deviations             - Corrective and Preventive Action Plans             - Internal audits     Products released on test results only     After Implementation of the Elite Quality System       Implemented a formal Quality Management System             - Defining a formal Corrective And Preventive Action Plan (CAPA)             - Formalized a Material Review Board (MRB) for critical deviation investigations             - Non critical deviations are reviewed by manufacturing             - Instituted product release protocols based on the Quality Assurance             review of manufacturing, packaging and quality control documents             - Developed a formal internal auditing program       ^ back to top   Q7A Element - "Personnel" Before Implementation of the Elite Quality System       Training curriculum for Quality Assurance personnel only     After Implementation of the Elite Quality System       Training curriculums are in place for the manufacturing, packaging and quality control departments       ^ back to top   Q7A Element - "Buildings & Facilities" Before Implementation of the Elite Quality System       Limited calibration of manufacturing equipment     After Implementation of the Elite Quality System       Maintenance and calibration programs for critical equipment were put in place       ^ back to top   Q7A Element - "Documentation & Records" Before Implementation of the Elite Quality System       Manufacturing master batch records were controlled and issued by manufacturing     Uncontrolled master packaging records     Manufacturing Operational Procedures (OP's) controlled by manufacturing     After Implementation of the Elite Quality System       Batch records             - Written, approved processes for manufacturing (MMP's),             packaging (MPF's), testing and release of raw materials and the final product             - Full Change Control: QA maintenance and issuances of master batch             record and operating procedures via a validated electronic document control system     Implemented a formal Quality Management System             - Instituted product release protocols based on the Quality Assurance             review of manufacturing, packaging and quality control documents       ^ back to top   Q7A Element - "Materials Management" Before Implementation of the Elite Quality System       Testing and release of bulk solvents only     No formal qualification of raw materials suppliers     After Implementation of the Elite Quality System       ID testing is performed on all incoming raw materials     Test a minimum of three lots, then accept on a Certificate of Analysis (C of A)     Specification agreements are established with raw material suppliers       ^ back to top   Q7A Element - "Production & Process Controls" Before Implementation of the Elite Quality System       No verification of critical steps by a second person     Acceptable yields not established     After Implementation of the Elite Quality System       Verification of critical steps by a second person     Acceptable yields are established and based on a statistical model       ^ back to top   Q7A Element - "Laboratory Controls" Before Implementation of the Elite Quality System       Reserve samples kept for a limited number of items only     After Implementation of the Elite Quality System       Reserve samples are kept for all products       ^ back to top   Q7A Element - "Validation" Before Implementation of the Elite Quality System       No verification of equipment cleanliness in a multiuse facility     No formal Installation Qualification/Operational Qualification (IQ/OQ) of equipment     After Implementation of the Elite Quality System       Cleaning verification protocol was approved and executed     Retrospective review of equipment documented     System in place for Installation Qualification/Operational Oualification (IQ/OQ)   of new equipment       ^ back to top   Q7A Element - "Change Control" Before Implementation of the Elite Quality System       Limited ability to notify of significant changes     After Implementation of the Elite Quality System       Formal QualityAgreements and Change Control Notification (CCN) are available       ^ back to top   Q7A Element - "Rejections & Re-Use of Materials" Before Implementation of the Elite Quality System       Manufacturing controlled     After Implementation of the Elite Quality System       Reprocessing and rework of materials are controlled by the Material Review   Board (MRB)       ^ back to top   Q7A Element - "Contract Manufacturers (Suppliers)" Before Implementation of the Elite Quality System       No formal system for approving contract manufacturers     After Implementation of the Elite Quality System       Contract manufacturers are evaluated thru an approved Vendor Qualification Program   and are subject to full change control notification       ^ back to top >> Questions? Inquiries? Contact a SAFC Supply Solutions Representative >> Return to Enhanced Quality Profile Program Section