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

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