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

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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

Top six deficiencies…… ISO 22716 Premises ✔ Raw materials and packaging materials Subcontracting Change control Internal audit Documentation

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

MONITOR & IMPROVE PLAN IMPROV ACT DO E CHECK

Our Action Plan Identify 2 actions that YOU can take responsibility for? - Audit actions - Identifying deficiencies - Sharing this message - P.D.C.A

Did we meet our 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 The learning pyramid?..........

Cosmetic GMP Typical audit findings and how to prevent them? THANK YOU QUESTIONS………… !