targets 1.ensure the control of the risk factors for the health of the consumers based in the...
TRANSCRIPT
TARGETS1. 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)
QUALITY HISTORY IN THE WORLD
Evolution
World
Chronology1900Inspection
made by the employee / supervisor
1920Quality
Control as a specialized
function
1940Statistical
Control of the process
1960Total
Quality
1980Systems of Quality Assurance
2000Quality
Systems Management
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.
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.
BASIC STRUCTURE OF THE GMP LEGISLATION IN LATAMA. General Provisions1. Scope.2. Definitions.3. Quality System.B. Quality Systems Requirements1. Management Responsibility.2. Quality Audit.3. PersonnelC. Design ControlsD. Documents ControlE. Purchasing ControlsF. Identification and Traceability1. Identification.2. Traceability of High Risk Products (class III
and IV).G. Production and Process Controls1. Production and Process Controls2. Special ProcessH. Inspection and Tests1. Inspection and Tests2. Inspection, Measurement and Test
Equipments3. Acceptance Status.
I.Nonconforming ProductJ.Corrective ActionK.Handling, Storage, Distribution and
Installation1.Handling2.Storage3.Distribution4.InstallationL.Packing and Labelling Controls1.Products Packing2.Products Labelling3.Labelling of Critical ProductsM.Records1.General Requirements2.Master Device Record3.Device History Record4.Quality System Record5.Complaint FilesN.ServicingO.Statistical Techniques
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:
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.
GENERIC VALUE CHAIN(according to Michael Porter)
Company’s Infrastructure
Human Resources Management
Technology Development
Purchasing
Inte
rnal
Log
istic
s
Ope
ratio
ns
Ext
erna
l Log
istic
s
Sal
es &
Mar
ketin
gServices
Primary Activities
Supp
ort
Activ
ities
INTEGRATED PROCESS
Project & Development
Quality
SalesPCP
Production Storage & Distribution
Client
Procurement
Supplier
Stock
Service
Client
MACRO-PROCESS
Quality Pyramid
Operational DocumentsQSP, WI, etc ...
Operat.Proced.
Manag.Proced.
Quality Manual
Quality Policy
Registrations
CREATING QUALITY CULTURE
Conscience
Objectives Self-Assessment
Corp
orati
veLe
ader
ship
Proc
ess
Perf
orm
ance
Information
Knowledge
Inteligence
InternalRelationship
Data
Cultu
re
ManagementSystem
General View of an Organizational Integrated Model
PDCA CYCLE
MANAGING QUALITY SYSTEM
CONTINUOUS IMPROVMENT OF THE QUALIY SYSTEM
MANAGEMENT RESPONSABILITY
RESOURCES MANAGEMENTMEASUREMENT, ANALISYS AND
IMPROVMENT
PRODUCT MANUFACTURING
CLIENTANDRA
AUTHORITIES
REQUIREMENT
CLIENT
SATISFACTION
CLIENT’SFEEDBACK
(P/A)
(P) (C/A)
(D)
OUTPUTINPUT PRODUCT
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.
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