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质量管理前沿领域 - TQMS 简介. 全面质量管理系统 Total Quality Management. Total Quality Management System (TQMS) AstraZeneca Solid Dosage Facility, Plankstadt, Germany. Ali Afnan AstraZeneca Pharmaceuticals Engineering Group Alderley House, Alderley Park Macclesfield, UK

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质量管理前沿领域 -TQMS简介

全面质量管理系统

Total Quality Management


Total quality management system tqms astrazeneca solid dosage facility plankstadt germany

Total Quality Management System (TQMS)AstraZeneca Solid Dosage Facility, Plankstadt, Germany

Ali Afnan

AstraZeneca

Pharmaceuticals Engineering Group

Alderley House, Alderley Park

Macclesfield, UK

[email protected]


Implementation of the tqm strategy
Implementation of the TQM Strategy

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


Tqms benefits i
TQMS Benefits- I

  • Enhanced product quality assurance

  • Significant manufacturing cost reduction

  • Reduction of product inventory

  • The elimination of end-of-line off-line testing

    • providing opportunity for a new way of working

    • significant increase in supply chain velocity

  • Reduces business risk

  • Increases competitive advantage

  • Allows “remote” regulatory inspection


Tqms dispensaries
TQMS- Dispensaries

  • Systems approach

    • NIR Analyser

      • Brimrose AOTF Multiplexed Analyser

      • Diffuse reflectance measurement (1100-2300 nm)

      • CIP and WIP probes

      • Performs the analyses at every dispensing operation

      • Allows control of recipe management

      • Release of incoming materials by the plant

    • Utilising

      • Bespoke 21CFR11 compliant software

      • Local panel PC’s

      • Barcode readers


Tqms dispensary operation
TQMS- Dispensary Operation

  • Operator scans material barcode (Article No. & Batch No.)

  • Analyser enabled for operation

    • Operator prompted through dispensing process

  • Trigger actuated by operator

    • Spectra collected with probe in-situ

  • I.D. reported & confirmed

  • Qualitative/ qualitative results reported & stored


Tqms fbd
TQMS- FBD

  • Probe permanently installed FBD

  • CIP and WIP probe designed to minimise fouling

  • Operator scans product barcode (Article No. & Batch No.)

    • Analyser enabled for operation

  • Predicted moisture values sent to FBD Control System for drying end point.


The blending process
The Blending Process

  • Process of changing the constituent matrices

  • Mixing (re-distribution) of particles of differing:

    • physical characteristics / chemical properties

  • Process of attrition & agglomeration

  • A complex process

  • Currently under scientific scrutiny

  • Driving a “holistic” re-assessment of blend process understanding and means of monitoring.


Tqms the blending process
TQMS- The Blending Process

Objectives are:

  • To monitor the “whole” powder mix in the blending vessel

  • Non-invasively & non-intrusively

  • To determine completion of the blending process

  • During every blending operation

  • To deliver consistent quality

  • Applicable to a range of blender types


Tqms nir blend monitoring system
TQMS NIR Blend Monitoring System

  • IBC with Sapphire window

  • Brimrose AOTF NIR “Free-Space” Analyser

  • Portable

  • Sample (Beam) size: 9 mm x 5 mm

  • Diffuse reflectance (1100-2300 nm)

  • Battery & mains operation

  • CIP and WIP analyser

  • All solid state hardware

  • Provides process reproducibility

  • 21CFR11 compliant package


Analyser interface
Analyser Interface

Eliminates the need for optical coupling




Tqms blender operation
TQMS Blender Operation

  • Real-time blend monitoring for “end-point” control &/or other parameters (active or excipient)

  • Stop signal transmitted to blender control unit on reaching ”end point”

  • On returning the analyser to Docking Station, data is down-loaded to data storage system

  • Batteries get recharged

  • Analyser is in stand-by until next batch






Tqms tablet analyser
TQMS Tablet Analyser

  • Unique, novel, purpose-built Brimrose AOTF analyser

    • Transmission (800-1300 nm) and,

    • Diffuse reflectance (1100-2300 nm)

  • Non-destructive, real-time tablets analysis of tablets ex press prior to check weighing system

  • IP65 instrument

  • CIP and WIP analyser

  • Vibration resistant

  • Up to 30 tablets per minute, different tablet size and shapes




Tqms tablet analyses
TQMS Tablet Analyses

  • For monitoring:

    • Moisture

    • I.D. of active (& excipient)

    • Concentration of active (& excipient)

    • Dissolution

    • Disintegration

    • Hardness

    • Density


Tqm system
TQM System

  • Manufacturing Operations responsible for Quality Assurance

  • Quality Control @ time of manufacture

  • Compliance @ point of use

  • @ every manufacturing process

  • Statistical process control

  • @ Lower cost than existing practices

  • Extensive testing & Analyses per manufacturing process


Acknowledgements

The NIR Team

Mr Robert Chisholm, Tech. Dev. Section Manager, PEG

Mr Simon Blackett, Tech. Dev. Section, PEG

Mr Ray Bolton, Tech. Dev. Section, PEG

Dr Johann Mueller- Plant Manager, PTF, PlankstadtDr Hubert Gotta- QA Manager, PlankstadtDr Christina Gerhaeusser- QA, Plankstadt

Dr Thorsten Herkert- QA, Plankstadt

Mr Peter Marshall- Process Engineer, Tech. Dev. Section, PEG

Mr Peter Jewitt- PTF Project Manager, PEG

Mr Daniel Frick, Development IS, Molndal

Mr Bengt Boissier, Development IS, Molndal

Acknowledgements