PCPC 2014 Quality Assurance Guidelines (PDF Download) - 2014 - Personal Care Products Council

PCPC 2014 Quality Assurance Guidelines (PDF Download) - 2014 - Personal Care Products Council

The Quality Assurance Guidelines provide approaches that cosmetic manufacturers can use for establishing their good manufacturing practices and quality assurance programs. The Guidelines provide a framework for establishing systems and procedures that are necessary to achieve a high level of product quality and avoid problems that could adversely affect the product. ISO Standard 22716 is included as a companion reference document with these Guidelines.

Table of Contents

Foreword

Acknowledgements

Table of Contents

List of Figures

Introduction

ISO 22716 Cosmetics Good Manufacturing Practices

Annex 1 Personnel and Training

Annex 2 Premises (Facility)

Annex 3 Equipment

Part 1 – Packaging          

Part 2 – Processing        

Annex 4 Raw Materials and Packaging Materials

Annex 5 Production Control

Annex 6 Finished Products/Lot Identification and Control

Annex 7 Quality Control Laboratory Operation

Annex 8 Treatment of Product that is Out of Specification

Annex 9 Recalls

Annex 10 Subcontractor Quality Assurance

Annex 11 Deviations

Annex 12 Consumer Complaints and Comments

Annex 13 Change Control

Annex 14 Internal Audit

Annex 15 Information Management Systems

Annex 16 Calibration Systems

Annex 17 Sampling

Part 1- General Provisions Sampling Plan            

Part 2 – Sampling and Control Techniques

Annex 18   Specifications   

Annex 19 Indices of Quality Performance          

Annex 20  Evaluating New or Revised Products     

Annex 21  New Packaging Quality

Annex 22  Classification of Defects              

Annex 23 FDA Inspections         

Annex 24 Regulatory Compliance Considerations           

Appendix PCMAP Checklist       

Glossary of Terms