GMP and ISO 22716 - HPRA
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Date Insert on Master Slide Slide 1 GMP and ISO 22716 Cosmetics Information Day , September 15 th 2010 Catherine Neary Inspector
Transcript of GMP and ISO 22716 - HPRA
Date Insert on Master Slide
Slide 1
GMP and ISO 22716
Cosmetics Information Day , September 15th 2010
Catherine NearyInspector
ISO 22716
• Introduction
• Scope PersonnelPremises and EquipmentProductionQuality ControlQuality Systems
• Next Steps
15 September 2010 Slide 2
Introduction
• Good Manufacturing Practice
is that part of Quality Assurance which ensures that products are consistentlyproduced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
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Introduction
Aims of ISO 22716
1. Guidance for organizing & conducting activities of a plant
2. Common/harmonised perception between companies and authorities
3. Reference document
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Scope - Personnel
Organization
Key Responsibilities
Training
Hygiene
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Scope - Premises and Equipment
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Proper Design
Cleaning and Sanitization
Maintenance
Calibration
Scope - Production
Materials Management
Manufacturing operations
Packaging operationsStorage
Shipment
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Production - Materials Management
Purchasing
Receipt
Identification and status
Release
Storage
Re-evaluation
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Production - Manufacturing/Packaging Operations
DOCUMENTATION
START-UP CHECKS
IN-PROCESS CONTROLS
STORAGE
SHIPMENT
RETURNS
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Scope - Quality Control
• Sampling• Specifications• Testing• OOS Investigation• Release
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Scope - Quality Systems
Documentation Control
Deviations
Complaints & Recalls
Internal audit
Change control
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Quality Risk Management
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Quality Risk Management‘A systematic process for the assessment, control, communication and review of risks to the quality of the product across the product lifecycle’
‘based on scientific knowledge, experience with the process and ultimately links to the protection of the consumer'
‘level of effort, formality and documentation commensurate with the level of risk’
Next Steps
• Gap Analysis• Action Plan• Implementation• Continuous Improvement
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In Summary - QUALITY MANAGEMENT
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GMP
QC
Quality Risk Management
QA
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