1. LOGFILE No. 12 / May 2013 Maas & Peither AG – GMP Publishing
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The Brazilian
GMP Guideline
By Dr. Hans H. Schicht
National and international companies man-
ufacturing pharmaceutical drugs, vaccines
and related products in Brazil are, of course,
subject to inspection by officials from ANVI-
SA (Agência Nacional de Vigilância Sanitária,
the National Health Surveillance Agency). In
recent years, ANVISA inspectors have, in
increasing scale, also been encountered
outside of Brazil, focussing their efforts on
enterprises marketing pharmaceutical prod-
ucts in Brazil. Such inspections are based on
the Brazilian GMP guidelines the latest
edition of which was published as Resolu-
tion Anvisa RDC No 17 dated 16 April 2010
in Portuguese [1]. Since then, an official
English translation has also been published
by ANVISA [2].
Point of departure for GMP in
Brazil
The newly elaborated Brazilian Federal
Constitution of 1988 determined health to
be a public right for which government on
all levels (federation, states, and municipali-
ties) is responsible. This was a novelty: earli-
er on, only persons formally contracted by
an employer plus their direct dependents as
well as pensioners with accumulated 30
years of formally contracted employment
had access to the public health system.
Legislation established, in 1990, the Sistema
Único de Saúde (SUS) which can be translat-
ed as Single Health System. It is one of the
most extensive public health systems in the
world: with SUS, the entire Brazilian popula-
tion - now passing the level of 200 million -
obtained access to the public health system,
i.e. to medical treatment, health stations
and hospitals, laboratory services, blood
centers, as well as to preventive actions such
as vaccination campaigns - all free of charge.
A special system of pharmacies was created
in this context, the Farmácias Populares,
serving exclusively people with low income.
They offer a basic selection of essential
medicines, with focus on generics, either
free of charge or at low cost. Presently, most
drug stores in Brazil are affiliated to this
system and operate a specific sector for
providing this service.
With the introduction of SUS, the Brazilian
government became the biggest purchaser
of medicines in the country. In order to
assure security, efficiency and quality of the
medicines sold through the SUS system as
well as through all the other pharmacies,
the implementation of GMP principles
became inevitable. Introducing GMP had a
most welcome side effect: all suppliers were
required to meet uniform quality standards
with the consequence that a fair point of
departure for competition between suppli-
ers was established; price reductions result-
ed as a consequence.
Introducing GMP to Brazil
Brazil is a member of the World Health
Organization (WHO). As such, it is obliged to
incorporate the WHO pharmaceutical quali-
ty assurance guidance into its national
health legislation system without major
deviations. The first Brazilian GMP guideline
was published in 1995. The present edition,
RDC no. 17/2010, is derived from the 2003
edition of the basic WHO GMP guide: Main
principles for pharmaceutical products -
Quality management in the drug industry:
philosophy and essential elements. Some
segments of RDC 17/2010, however, are
based upon more recent WHO guidances, or
upon guidance from other regulatory bod-
ies.
One important peculiarity deserves mention:
Whereas WHO uses the term "should" for
the individual determinations, in agreement
with the general practice in the standardiza-
tion and guidelines literature, the ANVISA
guidelines give preference to "must" de-
terminations.
GMP guidelines on related topics have also
been published by ANVISA, e.g. for active
pharmaceutical ingredients and for the
preparation of individual prescriptions in
healthcare pharmacies.
In the following, only determinations differ-
ing from those in the WHO GMP guideline
are addressed. This compilation is not com-
plete but only focuses on a few topics. For
more detailed information please find a

2. LOGFILE No. 12 / May 2013 Maas & Peither AG – GMP Publishing
http://www.gmp-publishing.com/
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comprehensive version of the article along
with the Brazilian GMPs in our next Update
for the GMP MANUAL.
A brief summary
Title I: Initial provisions
This chapter defines the scope and purpose
of RDC 17/2010. Minimum GMP require-
ments are established regarding manufac-
turing medicinal products in Brazil and
outside the country for the local market.
Methods not addressed in BPC 17/2010
resulting from technical progress or the
specific requirements of given products are
permitted to be adopted, provided they are
validated and do not prejudice the quality
of the product. Medicinal products are
subject to registration and may be produced
only by manufacturers duly licensed and
authorized; these companies are regularly
inspected by the responsible national au-
thorities. Occupational health topics and
environmental safety are, as a rule, not
addressed; however, manufacturers must
guarantee worker safety and take the nec-
essary steps for environmental protection.
Title II: Quality management
This Title follows closely the corresponding
general WHO GMP guideline: the structure
and its subdivision into a total of 17 chap-
ters are identical. Regarding the subject
matter presented in each chapter, it is,
however, structured differently. The Brazili-
an guideline is written in the style of the
legal document which it is: each Article
focusses on a single determination which
can be numerically referred to in inspection
reports and subsequently enforced if re-
quired.
One difference is regarding the "technically
responsible person". This function is re-
quired by law for all industrial companies
operating in Brazil. Its range of responsibili-
ties goes beyond that of the "authorized
person" in the WHO and the "qualified
person" in the EU GMP guidance. Title II
requires complaints regarding falsified
products and stolen cargo to be notified to
the responsible health authorities. Starting
and intermediate materials out of specifica-
tion must be investigated and actions ac-
cording to the CAPA procedure must be
taken.
Title III: Sterile products
This Title follows very closely the corre-
sponding WHO determinations published in
2002. WHO has since substituted them with
a new edition published in 2010. Two topics
(isolator technology, blow/fill/seal technolo-
gy) have been added in RDC 17/2010 to the
original WHO text. These have been repro-
duced, without any change, from the 2008
edition of Annex 1 to the EU GMP guide.
Regarding terminally sterilized products,
RDC 17/2010 is stricter than WHO: high risk
operations must be performed in grade C
conditions. Garments of persons working in
grade A/B areas must be changed after each
work session. Contrary to WHO, no excep-
tions are foreseen.
Title VII: Computer information systems
The original EU GMP guidance established in
Annex 11 has served as base for this Title.
The concepts of risk management and elec-
tronic signatures are not addressed. For the
validation of computerized systems, an
exhaustive guide has been prepared by
ANVISA in co-operation with professionals
from the Brazilian Chapter of ISPE - the
International Society of Pharmaceutical
Engineers.
Title VIII: Herbal medicines
This Title is based upon the corresponding
WHO guidance published in 2006 and pres-
ently in force. Determinations are estab-
lished for herbal medicines only, combina-
tion products with those of animal or min-
eral origin are not addressed. An appropri-
ate quality assurance system must be in
place, prime materials require adequate
control, and processes as well as methodol-
ogies must be validated. Herbal raw materi-
al derivatives containing genetically modi-
fied organisms must comply with the specific
standards in force.
Conclusion
The Brazilian GMP guideline RDC 17/2010
for medicinal products comprises not only
the generally applicable GMP stipulations,
but also covers a number of additional
topics such as sterile, biological and herbal
products, water for pharmaceutical use as
well as qualification and validation. Based
upon corresponding WHO GMP guidance

3. LOGFILE No. 12 / May 2013 Maas & Peither AG – GMP Publishing
http://www.gmp-publishing.com/
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which, on its part, is compatible with EU
GMP guidelines, it offers sound GMP guid-
ance without surprises.
References
[1] Ministério de Saúde, Agência
Nacional de Vigilância Sanitária ANVISA,
Resolução RDC No 17, de 16 de abril de
2010: Boas Práticas de Fabricação de
medicamentos (Ministry of Health, National
Health Surveillance Agency, Resolution RDC
No 17 of 16.04.2010: Good practices of
manufacturing medicinal products).
[2] ANVISA Resolution RDC No 17 of
16.04.10: Good practices of medicament
manufacturing (offizielle englischsprachige
Ausgabe).
Author:
Dr. Hans H. Schicht
Contamination Control Consulting
Langwisstrasse 5
8126 Zumikon
Switzerland
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