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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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Presentation Transcript
slide1

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

slide2
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
tqms the implementation of the strategy
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
implementation of the tqm strategy
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
slide5

TQM System Architecture

Quality Control

Quality Assurance

a solid dosage facility

NIR

NIR

NIR

NIR

A Solid Dosage Facility

Dispensary

FB

Drier

Wet granulation

Direct Compression

Milling

Press

Blender

Sieve

Coater