1. The EHPM Quality Guide: A template for best practice 10 December 2014 Michel Horn EHPM Quality Working Group

2. My Dual Role 1. Owner of a family run food supplement company specialised in botanicals 2. Member and Vice-Chair of EHPM’s Quality Working Group 10 December 2014

3. EHPM Mission “EHPM represents the interests of specialist health product manufacturers and distributors in Europe. It works towards developing an appropriate regulatory framework throughout the EU for its members' products, and promotes industry best practices for product quality and safety” 10 December 2014

4. Presentation Overview 1. EHPM Quality Guide Revision – The Vision 2. Key innovations in the quality guide 3. A virtual tour of the application of the guide in a food supplement facility 4. Conclusion 10 December 2014

5. 1. EHPM Quality Guide Revision – The Vision Update 2007 version to incorporate latest best practices & developments (manufacturing processes & analytical testing) Assist FS companies managing product quality and safety 10 December 2014

6. 1. EHPM Quality Guide Revision – The Vision Translate legal requirements to the practical reality of manufacturing FS Create a free and easily accessible tool that companies (mainly SME) can use 10 December 2014

7. 1. EHPM Quality Guide Revision – The Vision Provide a template for quality  safety + efficiency requirements Manageable for SMEs Context: debate on the expected regulatory frame for botanicals 10 December 2014

8. 2. Key Innovations A specific section devoted to FS including: ◦ Questionnaire for botanical preparation suppliers Measuring performance – checklists for: ◦ Manufacturer ◦ Sub contractors ◦ Raw material suppliers 10 December 2014

9. 2. Key Innovations Update to follow: ◦ Regulatory developments ◦ Evolution of manufacturing practices and analytical techniques A section explaining the difference between EU Member States on FS regulation All documents can be downloaded from the EHPM website 10 December 2014

10. 3. A virtual tour of the application of the guide in a food supplement facility 10 December 2014

11. 3. A virtual tour of the application of the guide in a food supplement facility 10 December 2014 Quality ProcessAchievement of 2 main goalsenables SAFE Doesn’t harm TRUTHFUL Deliver promise FUNDAMENTALS: = What is needed to develop and sell quality 1. Manufacturing: appropriate & validated 2. Scientific knowledge 3. Regulatory/legal knowledge 4. Being able to identify precisely consumer need = For a FS, QUALITY means it is SAFE & TRUTHFUL

12. IDENTIFIED Consumer Need Step 1 FUNDAMENTALS Quality ProcessenablesAchievement of 2 main goals

13. Step 1 Step 2 IDENTIFIED Consumer Need Product Idea SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects FUNDAMENTALS Quality ProcessenablesAchievement of 2 main goals Target Product Profile

14. Achievement of 2 main goals Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Theoretical formula -Ingredients -Form of intake -Labelling Step 3 SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects Legality of ingredients Goals: offering a product providing highest safety & efficiency criteria Formula provides efficient dosages FUNDAMENTALS Quality Processenables Product Development File

15. Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 4 Step 3 Theoretical formula -Ingredients -Form of intake -Labelling Final formula  Laboratory essays  Pilot production SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects Formula provides efficient dosages Legality of ingredients Goals: offering a product providing highest safety & efficiency criteria Stability of formula is tested Active ingredients must be present until end of shelf life FUNDAMENTALS Quality ProcessenablesAchievement of 2 main goals

16. SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects Formula provides efficient dosages Legality of ingredients Goals: offering a product providing highest safety & efficiency criteria Stability of formula is tested Active ingredients must be present until end of shelf life Interaction with competent authority Other EU countries: ie. Italy FUNDAMENTALS Quality ProcessenablesAchievement of 2 main goals Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 5 Step 3 Theoretical formula -Ingredients -Form of intake -Labelling Final formula  Laboratory essays  Pilot production Step 4  Validated formula/form Interaction with Competent authority Either notification/ authorization or information Authorities can verify: -legality -dosage of ingredients -Claims Authorities verify correspondence between ingredients & claims (notification) BE : Online notification via FOODSUP www.health.belgium.be/foodsup

17. Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 6 Step 3 Theoretical formula -Ingredients -Form of intake -Labelling Final formula  Laboratory essays  Pilot production Step 4  Validated formula/form Interaction with competent authority Either notification/ authorization or information Step 5 Marketable product Consumer Need FULFILLED SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects Formula provides efficient dosages Legality of ingredients Goals: offering a product providing highest safety & efficiency criteria Stability of formula is tested Active ingredients must be present until end of shelf life Authorities can verify: legality dosage of ingredients Claims Authorities verify: correspondence between ingredients & claims (notification) Production samples are reviewed in real time Consumer has a guarantee of stability/ effect during product’s lifetime FUNDAMENTALS Quality ProcessenablesAchievement of 2 main goals

18. Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 8 Step 3 Theoretical formula -Ingredients -Form of intake -Labelling Final formula  Laboratory essays  Pilot production Step 4  Validated formula/form Interaction with competent authority Either notification/ authorization or information Step 5 Marketable product Step 6 Consumer Need FULFILLED Step 7 Post Marketing Surveillance FUNDAMENTALS Quality ProcessenablesAchievement of 2 main goals ie. Complain from a client : issue with a broken blister  Input in our customer complaint system

19. Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 8 Step 3 Theoretical formula -Ingredients -Form of intake -Labelling Final formula  Laboratory essays  Pilot production Step 4  Validated formula/form Interaction with competent authority Either notification/ authorization or information Step 5 Marketable product Step 6 Consumer Need FULFILLED Step 7 Post Marketing Surveillance SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects Formula provides efficient dosages Legality of ingredients Goals: offering a product providing highest safety & efficiency criteria Stability of formula is tested Active ingredients must be present until end of shelf life Authorities can verify: legality dosage of ingredients Claims Authorities verify: correspondence between ingredients & claims (notification) Production samples are reviewed in real time Consumer has a guarantee of stability/ effect during product’s lifetime Controls by authorities at market level prevent illegal products being sold FUNDAMENTALS Quality ProcessenablesAchievement of 2 main goals

20. enables Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 8 Step 3 Theoretical formula -Ingredients -Form of intake -Labelling Final formula  Laboratory essays  Pilot production Step 4  Validated formula/form Interaction with competent authority Either notification/ authorization or information Step 5 Marketable product Step 6 Consumer Need FULFILLED Step 7 Post Marketing Surveillance SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects Formula provides efficient dosages Legality of ingredients Goals: offering a product providing highest safety & efficiency criteria Stability of formula is tested Active ingredients must be present until end of shelf life Authorities can verify: legality dosage of ingredients Claims Authorities verify: correspondence between ingredients & claims (notification) Production samples are reviewed in real time Consumer has a guarantee of stability/ effect during product’s lifetime Controls by authorities at market level prevent illegal products being sold HACCPHACCP FUNDAMENTALS Quality Process TRACEABILITYTRACEABILITY

21. Achievement of 2 main goalsenables Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 8 Step 3 Theoretical formula -Ingredients -Form of intake -Labelling Final formula  Laboratory essays  Pilot production Step 4  Validated formula/form Interaction with competent authority Either notification/ authorization or information Step 5 Marketable product Step 6 Consumer Need FULFILLED Step 7 Post Marketing Surveillance SAFE doesn’t harm TRUTHFUL deliver promise Safe ingredients Assessed physiological effects Formula provides efficient dosages Legality of ingredients Goals: offering a product providing highest safety & efficiency criteria Stability of formula is tested Active ingredients must be present until end of shelf life Authorities can verify: legality dosage of ingredients Claims Authorities verify: correspondence between ingredients & claims (notification) Production samples are reviewed in real time Consumer has a guarantee of stability/ effect during product’s lifetime Controls by authorities at market level prevent illegal products being sold HACCPHACCP FUNDAMENTALS Quality Process TRACEABILITYTRACEABILITY

22. 4. Conclusion The food supplement sector is committed to producing safe and quality products that deliver genuine health benefits The sector embraces high quality standards It proposes collaboration with regulators to improve standards when relevant Our sector is dominated by SMEs which need workable regulation 10 December 2014

23. Thanks for your attention ceo@ortis.com 10 December 2014