Biological Buffers

Biological Buffers Quality System

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

Back to Top

Q7A Element - "Personnel"
  • Training curriculums are in place for the manufacturing, packaging and quality control departments

Back to Top

Q7A Element - "Buildings & Facilities"
  • Maintenance and calibration programs for critical equipment were put in place

Back to Top

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

Back to Top

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

Back to Top

Q7A Element - "Production & Process Controls"
  • 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"
  • Reserve samples are kept for all products

Back to Top

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

Back to Top

Q7A Element - "Change Control"
  • Formal QualityAgreements and Change Control Notification (CCN) are available

Back to Top

Q7A Element - "Rejections & Re-Use of Materials"
  • Reprocessing and rework of materials are controlled by the Material Review Board (MRB)

Back to Top

Q7A Element - "Contract Manufacturers (Suppliers)"
  • Contract manufacturers are evaluated thru an approved Vendor Qualification Program and are subject to full change control notification

Visit SAFC for all of your bulk and custom manufacturing needs


Back to Top




 

Back to Biological Buffers