| Many of Sigma-Aldrich's customers, who purchase buffer products, have the expectation of Sigma-Aldrich to utilize a quality system that manages and evaluates change as well as showing evidence of controlled, consistent processes. Sigma-Aldrich uses a quality system modeled on elements of ICHQ7A, a global GMP guideline for Active Pharmaceutical Ingredients (API's) for the pharmaceutical industry. |
Q7A Element - "Quality Management"
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
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Q7A Element - "Personnel"
- Training curriculums are in place for the manufacturing, packaging and quality control departments
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Q7A Element - "Buildings & Facilities"
- Maintenance and calibration programs for critical equipment were put in place
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Q7A Element - "Documentation & Records"
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
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Q7A Element - "Materials Management"
- 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
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Q7A Element - "Production & Process Controls"
- Verification of critical steps by a second person
- Acceptable yields are established and based on a statistical model
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Q7A Element - "Laboratory Controls"
- Reserve samples are kept for all products
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Q7A Element - "Validation"
- 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
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Q7A Element - "Change Control"
- Formal QualityAgreements and Change Control Notification (CCN) are available
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Q7A Element - "Rejections & Re-Use of Materials"
- Reprocessing and rework of materials are controlled by the Material Review Board (MRB)
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Q7A Element - "Contract Manufacturers (Suppliers)"
- Contract manufacturers are evaluated thru an approved Vendor Qualification Program and are subject to full change control notification
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