2. TARGETS 1.Ensure the Control of the Risk Factors for the health of the consumers based in the Mercosur harmonized legislation and norms; 2.Definition of parameters for audit and inspection based in the GMP- (BPF); 3.Scope: A.Local Manufactures; B.Importers / Distributors; C.Foreign Manufacturers (Extra Zone Inspection)

3. QUALITY HISTORY IN THE WORLD Evolution World Chronology 1900 Inspection made by the employee / supervisor 1920 Quality Control as a specialized function 1940 Statistical Control of the process 1960 Total Quality 1980 Systems of Quality Assurance 2000 Quality Systems Management

4. QUALITY SYSTEMS FEATURES & BENEFIS Features: Defined systems. Measurable. Standardization. Performance Indicators. Benefits: Costs reduction. Control of the measurable parameters. Process monitoring. Domain of the process (reliability). Routine optimization. Objective improvement of the goods.

5. GMP IN LATIN AMERICA All companies must receive GMP certification otherwise may be punished according to the local legislation. Despite the fact that the certification applies to companies dealing with products risk I, II III and IV, the local regulatory authorities may push those who manufacturer / distribute products risk class III and IV.

6. BASIC STRUCTURE OF THE GMP LEGISLATION IN LATAM A.General Provisions 1.Scope. 2.Definitions. 3.Quality System. B.Quality Systems Requirements 1.Management Responsibility. 2.Quality Audit. 3.Personnel C.Design Controls D.Documents Control E.Purchasing Controls F.Identification and Traceability 1.Identification. 2.Traceability of High Risk Products (class III and IV). G.Production and Process Controls 1.Production and Process Controls 2.Special Process H.Inspection and Tests 1.Inspection and Tests 2.Inspection, Measurement and Test Equipments 3.Acceptance Status. I.Nonconforming Product J.Corrective Action K.Handling, Storage, Distribution and Installation 1.Handling 2.Storage 3.Distribution 4.Installation L.Packing and Labelling Controls 1.Products Packing 2.Products Labelling 3.Labelling of Critical Products M.Records 1.General Requirements 2.Master Device Record 3.Device History Record 4.Quality System Record 5.Complaint Files N.Servicing O.Statistical Techniques

7. COMPATIBILITY AMONG ISO 9000 X ISO 13485 X LATAM GMP X 21CFR ISO 13485 (100%) ISO 13485 (100%) LATAM GMP (95%) LATAM GMP (95%) 21 CFR (95%) 21 CFR (95%) ISO 9001 (90%) ISO 9001 (90%)

8. SOME COMMENTS FROM A LATAM NATIVE… Despite the targets that talk about Control of the Risk Factors for the health of the consumers based in the Mercosur harmonized legislation and norms, there is a political side that has to be considered. The LATAM governments decided (also) to adopt one quality system in order to: 1.Create a local culture of Quality; 2.Push the quality of the local Medical Devices and IVD kits into a worldwide acceptance range, creating more jobs; 3.Push the prices of the local MD and IVD into a worldwide level, what generates more tax collected; 4.Improve exportations; 5.Avoid importation of bad quality MD and IVD. Summarizing: regulatory affairs can be (and effectively are) as an instrument of government in order to improve economy, create non tariff barriers, besides the protection of the people health. Quality Systems are definitely included in this scenario.

9. GENERIC VALUE CHAIN (according to Michael Porter) Company’s Infrastructure Human Resources Management Technology Development Purchasing Internal LogisticsOperations External Logistics Sales & Marketing Services Primary Activities Support Activities

10. INTEGRATED PROCESS Project & Development Quality Sales PC P Production Storage & Distribution Client Procure ment Supplier Stock Service Client MACRO-PROCESS

11. Quality Pyramid Operational Documents QSP, WI, etc... Operat. Proced. Manag. Proced. Quality Manual Quality Policy Registrations

12. CREATING QUALITY CULTURE Conscience Objectives Self-Assessment Corporative Leadership Process Performance Information Knowledge Inteligence Internal Relationship Data Culture Management System General View of an Organizational Integrated Model

13. PDCA CYCLE

14. MANAGING QUALITY SYSTEM CONTINUOUS IMPROVMENT OF THE QUALIY SYSTEM MANAGEMENT RESPONSABILITY RESOURCES MANAGEMENT MEASUREMENT, ANALISYS AND IMPROVMENT PRODUCT MANUFACTURING CLIENT AND RA AUTHORITIES REQUIREMENT CLIENT SATISFACTION CLIENT’S FEEDBACK (P/A) (P)(C/A) (D) OUTPUT INPUT PRODUCT

15. CONCLUSION (I) The Latin America region started to develop mandatory GMP quality systems since 2000 despite the voluntary ISO 9000 certifications previously granted; All companies must be certified according to LATAM GMP; The certification is a pre-requirement for the products registration specially for risk class III and IV; GMP must be renewed annually; Certification of Foreign Manufacturers (Extra Zone Inspection)

16. CONCLUSION (II) LATAM clients are more demanding about good quality products day after day (learning curve); Employees from companies established in LATAM learned about QS leading to a new level of quality inside the said companies (learning curve). Summarizing: the LATAM GMP is helping to create a new level of culture among companies and clients, including doctors, hospitals, clinics, labs and common users. Companies must pay attention to this social/economical consequence.

18. Latini & Associados