glps and quality management systems meeting 2015/track iii...and process integrity –issues...
TRANSCRIPT
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GLPs and Quality Management
Systems The Potential to Increase Compliance
Milica Vogt
Quality Assurance Team Lead
Monsanto Company
NAICC 2015 Annual Meeting
1/22/2015
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Agenda
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• What is a Quality Management System (QMS)?
• Different Types of QMS
• Similarities and Differences between GLP and
ISO 9001 QMS (International Organization for
Standardization)
• Benefits of ISO QMS to the GLPs
• Summary
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What is a QMS?
Collective policies, plans, practices, and the
supporting infrastructure that enables an
organization to identify, measure, control and
improve the various core business processes
that will ultimately lead to improved business.
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Types of QMS
• General
• ISO 9001 – Quality Management System Requirement
• Industry and Product Specific
• TL 9000 – telecommunications
• API-Q1 – petroleum, petrochemical and natural gas
• Process Specific
• GLP (FDA, EPA...) – conduct of non-clinical laboratory studies
• ISO 17025 – general requirements for the competence of testing and calibration laboratories
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•Equipment
•Procedures
•Records
•Management
•QC
•Training*
•Audit*
•Corrective actions*
Shared GLP ISO 9001
QMS Requirements: GLP and ISO 9001
•Test System
•Master Schedule
•Study Workflow
•Study Director
•Archivist
•QAU
•Customer Feedback
•Continuous Improvement
•Procurement
•Preventative Actions
•Management Review
•Metrics
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*Different implementation of shared requirements
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Differences in Implementing
Shared Requirements
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GLP ISO 9001
Training Understanding SOP Understanding SOP Competency training
Audit Independent of study conduct
Part of the process
Corrective actions Address issues for the study
Root cause analysis
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Potential Benefits of Adding ISO
9001 Requirements to GLPs
• Drives implementation of permanent solutions to
entire organization
• Increase organizational effectiveness
• Imbeds continuous improvement into the culture
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GLP
– Study/Facility issues are assessed for impact to study integrity
– QA identifies non-compliance, reports findings and ensures
findings are addressed
ISO 9001
– Study/Facility issues are assessed for impact to product (study)
and process integrity
– Issues (non-conformities) documented in a CAPA process
– Preventative Actions and Opportunities for Improvement
identified and tracked (CARs PARs, OFIs)
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Drives Implementation of Permanent
Solutions Management of Non-Compliance
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GLP
• QA communicates all issues to Study Director and
Management via audit report
• Reports can be seen as punitive
ISO 9001
• Teams discuss all issues and overall quality status
during Management Review Meetings
• Open dialogue, management support, shared ownership
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Increases Organizational Effectiveness Communication to Management on Quality
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GLP • Each study is treated independently, not built into
system
ISO 9001 • Continuous improvement built into the system
• Effectiveness, efficiencies and their interactions are measured and tracked
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Imbeds Continuous Improvement Into
the Culture Continuous Improvement
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Summary
GLP – minimum requirement that we must meet to ensure
data integrity
– It’s the Law!
ISO 9001 – May enhance GLP compliance
– Additional aspects of Training, Corrective Actions
– Select QMS Specific requirements (Continuous Improvement, identifying and implementing permanent solutions to the issues)
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Thank you!
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