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TQMS

TQMS. STATISTICALLY BASED IN-PROCESS CONTROL WITH REAL TIME QUALITY ASSURANCE The AstraZeneca Total Quality Management Strategy R S Chisholm International Technology Manager November 2001 Bob.chisholm@astrazeneca.com. TQMS. Traditional QA

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TQMS

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  1. TQMS STATISTICALLY BASED IN-PROCESS CONTROL WITH REAL TIME QUALITY ASSURANCE The AstraZeneca Total Quality Management Strategy R S Chisholm International Technology Manager November 2001 Bob.chisholm@astrazeneca.com

  2. TQMS Traditional QA • Validated Processes managed by standard operation procedures • End of Batch off-line QA Testing on a small random sample TQMS • Real Time In Process Monitoring and Control • Real Time Quality Assurance statistically based throughout Batch Manufacture – Increased testing providing the Platform for parametric release

  3. TQMS – THE IMPLEMENTATION OF THE STRATEGY • Sponsorship by the Senior Executive Team of AZ – THE PARADIGM SHIFT • Creation of a Process Analytical Centre of Excellence • Integration of TQMS into design of potent product solid dosage facility sanctioned early 1999 in Plankstadt (Germany) • THE PTF PROJECT

  4. IMPLEMENTATION OF THE TQM STRATEGY Statistically Based In-process Control & Monitoring • Key Process Operations • Identification/specification of all incoming raw materials in the dispensaries (& the warehouse) • Fluid Bed Drier end point control • Continuous in-line monitoring of blending & end point control • In-line monitoring of Tablet Quality Parameters against registered specifications • 21CFR11 Compliant data management system • Real-time continuous quality assurance • The Platform for parametric release

  5. TQM System Architecture Quality Control Quality Assurance

  6. NIR NIR NIR NIR A Solid Dosage Facility Dispensary FB Drier Wet granulation Direct Compression Milling Press Blender Sieve Coater

  7. Blend Monitoring Unit

  8. Tablet Analyser – Lab based

  9. In-line TQMS Tablet Analyser

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