Biological Buffers Quality System
Many of our customers who purchase buffer products expect us to use a quality system that manages and evaluates change, as well as shows evidence of controlled, consistent processes. We use 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"
- 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
Q7A Element - "Personnel"
- Training curriculums are in place for the manufacturing, packaging and quality control departments
Q7A Element - "Buildings & Facilities"
- Maintenance and calibration programs for critical equipment were put in place
Q7A Element - "Documentation & 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
- Instituted product release protocols based on the Quality Assurance review of manufacturing, packaging and quality control documents
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 (CofA)
- Specification agreements are established with raw material suppliers
Q7A Element - "Production & Process Controls"
- Verification of critical steps by a second person
- Acceptable yields are established and based on a statistical model
Q7A Element - "Laboratory Controls"
- Reserve samples are kept for all products
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
Q7A Element - "Change Control"
- Formal Quality Agreements and Change Control Notification (CCN) are available
Q7A Element - "Rejections & Re-Use of Materials"
- Reprocessing and rework of materials are controlled by the Material Review Board (MRB)
Q7A Element - "Contract Manufacturers (Suppliers)"
- Contract manufacturers are evaluated thru an approved Vendor Qualification Program and are subject to full change control notification