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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