1. GDP A UDITS WHAT TO EXPECT HOW TO PREPARE OBLIGATIONS AND REGULATIONS BEST PRACTICES AND INDUSTRY INSIGHTS Nick POPLE GDP Expert Pauwels Consulting

2. www.pauwelsconsulting.com O VERVIEW Brief introduction: My background in the GDP industry Contents of this presentation: GDP: why, how, how not Goals of this presentation: Share GDP insights from an auditor’s point of view Share GDP insights from an operator’s point of view 2

3. www.pauwelsconsulting.com MY HISTORY WITH EU GDP First GDP regulations drafted in the 1980’s Initial focus My involvement in its evolution Current status Pharmaceutical products CD’s Controlled drugs Clinical trials Patient name only Medical devises Veterinary products Cosmetics Dentistry 3

4. www.pauwelsconsulting.com O VER THE YEARS I HAVE CARRIED OUT Regulatory audits Manufacturer audits External audits Internal audits 4

5. www.pauwelsconsulting.com I N THIS PRESENTATION I WILL COVER What to expect from an audit How to prepare for an audit How to approach an audit What regulations to follow 5

6. www.pauwelsconsulting.com A ND I WILL SHARE Industry insights Best practises Do’s (examples) Don’ts (examples) 6

7. www.pauwelsconsulting.com “A ND TO KICK OFF ” Regulatory audit Manufacturer audit External audit Internal audit 7 FOCUSISO 9001:GDP Business Processes & ManagementYesNo Customer RequirementsYesNo Product & Process AssurancePartlyYes Mandatory for Pharma/VeterinaryNoYes Recognition by Regulatory AuthoritiesNoYes Compliance to Product StandardsPartlyYes Continuous ImprovementYesNo

8. www.pauwelsconsulting.com H OW TO PREPARE FocusMajorCriticalMinor Cleaning/Housekeeping NC & CAPA Management Pest Control Temperature Monitoring & Mapping TMS Process & Validation Documentation Order Management, Shipping & Cross- docking Damaged/Rejected Products Training Internal Audits Compliant Handling Vendor Management Change Management Personnel Management Management Review Fleet Maintenance

9. www.pauwelsconsulting.com Open and Honest Understand the Type of Audit Except Criticism Constructively Do not Hide Behind Company Policies Do not Offer Lunch Off Site O BLIGATIONS

10. www.pauwelsconsulting.com Treat the Audit as an Opportunity to Maintain Compliance Audits will be part of new business tender qualification O BLIGATIONS

11. www.pauwelsconsulting.com O BLIGATIONS Standards of Good Distribution Practice are applied to ensure that the high level of product quality is achieved and maintained throughout the distribution network WHY GDP? To facilitate free movement of medicinal products within the European Community To exercise control over the distribution chain of medicinal products from manufacture or import into the EC to supply to the public

12. www.pauwelsconsulting.com B EST PRACTICES AND INDUSTRY INSIGHTS Evolution of GMP/GDP - “Trust Me!” Cola 1906contains cocaine Sulphanilamide 1938100s died Thalidomide 19621000s deformed IUD Device 197413 deaths Tylenol sabotage 19826 deaths Breast Implants 1992recalled Glycol Injections 199960 children die Current Issues 22% of all serious deficiencies are temperature related Quality system documentation Returns

13. www.pauwelsconsulting.com B EST PRACTICES AND INDUSTRY INSIGHTS Serious GDP deficiencies in one market DESCRIPTIONNumber% General storage - temperature control & monitoring3319.6 Cold chain - temperature control & monitoring2615.5 Lack of or inadequate written procedures2112.5 Returns - handling and records158.9 Stock rotation and control137.7 Quality system & duties of the Responsible Person127.1 Premises, equipment, calibration106.0 Segregation of unsaleable goods95.4 General transportation/delivery74.2 Housekeeping and pest control63.6

14. www.pauwelsconsulting.com I N THIS PRESENTATION WE DISCUSSED A brief history of GDP GDP: why, how, how not I hope I have shared valuable GDP insights from an auditor’s point of view GDP insights from an operator’s point of view I hope this will help you to Prepare for and follow-up on regulatory, manufacturer, external, internal audits 14

15. nick.pople@pauwelsconsulting.com www.pauwelsconsulting.com F OR MORE INFORMATION 15