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TARGETS. Ensure the Control of the Risk Factors for the health of the consumers based in the Mercosur harmonized legislation and norms; Definition of parameters for audit and inspection based in the GMP- (BPF); Scope: Local Manufactures; Importers / Distributors;
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TARGETS • Ensure the Control of the Risk Factors for the health of the consumers based in the Mercosur harmonized legislation and norms; • Definition of parameters for audit and inspection based in the GMP- (BPF); • Scope: • Local Manufactures; • Importers / Distributors; • Foreign Manufacturers (Extra Zone Inspection)
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 QUALITY HISTORY IN THE WORLD
QUALITY SYSTEMS FEATURES & BENEFIS • Benefits: • Costs reduction. • Control of the measurable parameters. • Process monitoring. • Domain of the process (reliability). • Routine optimization. • Objective improvement of the goods. • Features: • Defined systems. • Measurable. • Standardization. • Performance Indicators.
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.
General Provisions Scope. Definitions. Quality System. Quality Systems Requirements Management Responsibility. Quality Audit. Personnel Design Controls Documents Control Purchasing Controls Identification and Traceability Identification. Traceability of High Risk Products (class III and IV). Production and Process Controls Production and Process Controls Special Process Inspection and Tests Inspection and Tests Inspection, Measurement and Test Equipments Acceptance Status. Nonconforming Product Corrective Action Handling, Storage, Distribution and Installation Handling Storage Distribution Installation Packing and Labelling Controls Products Packing Products Labelling Labelling of Critical Products Records General Requirements Master Device Record Device History Record Quality System Record Complaint Files Servicing Statistical Techniques BASIC STRUCTURE OF THE GMP LEGISLATION IN LATAM
COMPATIBILITY AMONG ISO 9000 X ISO 13485 X LATAM GMP X 21CFR ISO 13485 (100%) LATAM GMP (95%) 21 CFR (95%) ISO 9001 (90%)
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: • Create a local culture of Quality; • Push the quality of the local Medical Devices and IVD kits into a worldwide acceptance range, creating more jobs; • Push the prices of the local MD and IVD into a worldwide level, what generates more tax collected; • Improve exportations; • 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.
GENERIC VALUE CHAIN(according to Michael Porter) Company’s Infrastructure Support Activities Human Resources Management Technology Development Purchasing Internal Logistics Sales & Marketing External Logistics Operations Services Primary Activities
INTEGRATED PROCESS MACRO-PROCESS Project & Development Quality PCP Sales Client Client Production Storage & Distribution Procurement Service Supplier Stock
Quality Pyramid Quality Policy Quality Manual Operat. Proced. Manag. Proced. Operational Documents QSP, WI, etc ... Registrations
CREATING QUALITY CULTURE General View of an Organizational Integrated Model Objectives Self-Assessment Data Management System Information Corporative Leadership Process Culture Performance Internal Relationship Knowledge Inteligence Conscience
PDCA CYCLE P D A C
MANAGING QUALITY SYSTEM CONTINUOUS IMPROVMENT OF THE QUALIY SYSTEM CLIENT CLIENT AND RA AUTHORITIES MANAGEMENT RESPONSABILITY (P/A) MEASUREMENT, ANALISYS AND IMPROVMENT SATISFACTION RESOURCES MANAGEMENT REQUIREMENT CLIENT’S FEEDBACK (P) (C/A) OUTPUT INPUT PRODUCT MANUFACTURING PRODUCT (D)
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)
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.
