Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

GMP - ISO 22716

14,213 views

Published on

This presentation talks about the cosmetics good manufacturing practice (GMP) and standard ISO 22716, which cosmetic manufacturers have to follow if they want to put their products on the EU market.

Published in: Business, Technology

GMP - ISO 22716

  1. 1. EU REGULATION 1223/2009 & ISO 22716 © CE.way Regulatory Consultants Ltd
  2. 2. LEGISLATION • EU cosmetic regulation 1223/2009 (replacing directive 76/768/EC) • Applicable: July 2013 onwards © CE.way Regulatory Consultants Ltd
  3. 3. COSMETIC GMP – ISO 22716 • One of the pillars of the EU cosmetics Regulation • To ensure their safety, cosmetic products placed on the EU market should be produced according to good manufacturing practice (GMP) • Compliance with GMP is presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union  ISO 22716:2007 © CE.way Regulatory Consultants Ltd
  4. 4. COSMETIC GMP – ISO 22716 • ISO 22716 also has direct links to many other cosmetic regulations in place around the world  Regulators in several countries and regions have adopted this standard • ISO 22716 gives guidance for the production, control, storage and shipment of cosmetic products. It deals with all aspects of the supply chain of cosmetic products • It covers the quality aspects of the products, but it does not cover:  Safety aspects for the personnel engaged in the plant  Protection of the environment  Not applicable to research and development activities © CE.way Regulatory Consultants Ltd
  5. 5. COSMETIC GMP – ISO 22716 ISO 22716 provides guidance in a number of areas, which can be broadly divided into 5 categories: • Personnel • Premises and equipment • Production • Quality control • Quality systems © CE.way Regulatory Consultants Ltd
  6. 6. ISO 22716 – PERSONNEL • Organization • Key responsibilities • Training • Hygiene © CE.way Regulatory Consultants Ltd
  7. 7. ISO 22716 – PREMISES AND EQUIPMENT • Proper design • Cleaning and sanitization • Maintenance • Calibration © CE.way Regulatory Consultants Ltd
  8. 8. ISO 22716 – PRODUCTION © CE.way Regulatory Consultants Ltd Materials management Manufacturing operations Packaging operations Storage Shipment • Purchasing • Receipt • Identificati on and status • Release • Storage • Re- evaluation • Documentation • Start-up checks • In-process controls • Storage • Shipment • Returns
  9. 9. ISO 22716 – QUALITY CONTROLS • Sampling • Specifications • Testing • Out of specification investigation • Release © CE.way Regulatory Consultants Ltd
  10. 10. ISO 22716 – QUALITY SYSTEMS © CE.way Regulatory Consultants Ltd Documentation control Deviations Complaints & recalls Internal audit Change control
  11. 11. www.ceway.eu info@ceway.eu © CE.way Regulatory Consultants Ltd

×