Cosmetic GMP Typical audit findings and how to prevent Key Learning - - PowerPoint PPT Presentation
Cosmetic GMP Typical audit findings and how to prevent Key Learning Objectives 1. ISO 22716 know our standard 2. Top 6 deficiencies 3. Understanding reasons for repetition? 4. Fix It 5. Monitor and Improve 6. Our Action Plan Warning!
Cosmetic GMP Typical audit findings and how to prevent Key Learning Objectives
Warning!
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Know our Standard: ISO 22716 Personnel 6 Premises 13 Equipment 9 Raw materials and packaging materials 8 Production 3 Finished Products 5 QC Laboratory 8 Treatment of product that is OOS 2 Wastes 5 Subcontracting 5 Deviations 2 Complaints and recalls 3 Change control 1 Internal audit 3 Documentation 5
ISO 22716 Premises Raw materials and packaging materials Subcontracting Change control Internal audit Documentation
Top six deficiencies……
Premises Contamination risks
Risk Reason for Repetition
Raw materials and packaging Controls
Reason for Repetition
Sub contracting Scope and Responsibilities
Reason for Repetition
Change control Process for change control
Reason for Repetition
Internal audit Performance
Reason for Repetition
Documentation Design, control and completion
Reason for Repetition
Fix It! Group work Consider: Leadership, Behaviours, Action, and……..
Fix It…….. It helps if……. Simple Tangible benefit…focus on the positive Ownership
IMPROV E
PLAN DO CHECK ACT
MONITOR & IMPROVE
Our Action Plan Identify 2 actions that YOU can take responsibility for?
Did we meet our learning objectives?
The learning pyramid?..........
Cosmetic GMP Typical audit findings and how to prevent them? THANK YOU QUESTIONS…………!