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A Quality Management System for GCP

A Quality Management System for GCP. Prepared by Piera Lukes and Bernard Hall For Henry Stewart Conference: SOPs in Clinical Research London 20-21 March 2003. Agenda. GCP requirement for QMS Integrating ISO and GCP Policies and Procedures How to design Process SOPs The QMS process

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A Quality Management System for GCP

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  1. A Quality Management System for GCP Prepared by Piera Lukes and Bernard Hall For Henry Stewart Conference: SOPs in Clinical Research London 20-21 March 2003

  2. Agenda • GCP requirement for QMS • Integrating ISO and GCP • Policies and Procedures • How to design Process SOPs • The QMS process • Other QMS

  3. GCP Requires • Systems with procedures that assure the quality of every aspect of the trial should be implemented (ICH 3.12). • The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP and the applicable regulatory requirements (ICH 5.1.1).

  4. Management Responsibility Plan Act Resource Management Measurements Analysis and improvement Do Check Product Realisation ISO Model Customers Customers Customer Satisfaction Input Output Requirements Product

  5. Study Planning Study Conduct Data Handling Reporting The IT’sQA QMS Customers Customers ISO Input Requirements Output Customer Satisfaction ICH

  6. Policies/SOPs (Required by ISO) • Quality Policy (ISO 5.3) • Quality Manual (ISO 4.2.2) • Document Management (ISO 4.2.3) • Records Management (ISO 4.2.4) • Internal Audits (ISO 8.2.2) • Corrective actions (ISO 8.5.2) • Preventive actions (ISO 8.5.3).

  7. Policies/SOPs (ICH) • Clinical Trial Conduct (ICH 5.1.1) • Clinical Data Process (ICH 5.1.1) • Computer Systems (ICH 5.5.3) • Monitoring (ICH 5.18.5) • Quality Assurance Audits (ICH 5.19.3) • Supply and handling of IP (ICH 5.14.3) • Other relevant SOPs to demonstrate GCP and regulatory compliance throughout the whole clinical trial process

  8. Study Planning Study Conduct Data Handling Reporting Process: The Process An activity using resources, and managed in order to enable the transformation of inputs into outputs Customers Customers • IP • Protocol • Subjects Data; e.g Report Input Output Product

  9. Management Responsibility Plan Act Resource Management Measurements Analysis and improvement Do Check Product Realisation Quality Process 1 Communication Communication Plan-Do-Check-Act Customers Customers Satisfaction Input Output Requirements Product

  10. Quality Process 2 Communication Communication A process in conformance with the users’ requirements; A process that is fit for purpose The Process Customers Customers • Protocol • Helsinki • ICH • Regulatory • Business requirements: efficiency, time to market, cost, etc. • Subjects • IRB/EC • Investigators • RA • Investors • others Satisfaction Input Output Requirements Product QUALITY IS A MOVING TARGET

  11. Process SOPs • Nominate a Process Owner (needs a team) • Determine the user's requirements • Map the process • Determine measures for the process (effectiveness and efficiency) • Validate the process • Improve the process

  12. Process Mapping • Assign a name to the process • Establish start and end points of process • Determine the output(s) (use nouns) • Determine the customers • Determine the suppliers • Determine the input • Agree on 5-7 high level steps of process (use nouns and adjectives) Repeat for sub-processes

  13. Quality Standards • 6 Sigma's • EFQM • Baldridge • Deming • Others

  14. The Process: A Team Effort Brainstorming

  15. Be Patient! Choose a Good Team and Play! May need to use Soft Tools!

  16. Conclusions The IT’sQA QMS • Ensures compliance with GCP, users and business requirements • Ensures controls of the interfaces • Produces process SOPs that are validated • Incorporates user’s training • Enables ISO certification by accredited UKAS certification bodies

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