This document summarizes the ANVISA GMP guidelines for Brazil. It begins with an introduction noting that Brazil incorporates WHO pharmaceutical quality assurance guidelines into national legislation. The guidelines cover initial provisions, quality management, sterile products, computer information systems, and herbal medicines. For each section, the document compares the Brazilian guidelines to WHO guidelines, noting areas where Brazil has additional or stricter requirements. The conclusion states that in addition to generally applicable GMP stipulations, the Brazilian guidelines also address sterile products, biological and herbal products, water for pharmaceutical use, and qualification and validation.
3. INTRODUCTION:
• Brazil is a member of World Health Organization.
• It is obliged to incorporate the WHO pharmaceutical quality assurance
guidelines into national health legislation system without major
deviations.
• The first Brazilian GMP guideline was published in 1995.
• Latest edition 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.
• WHO - ‘should’ ANVISA - ‘must’
4. INITIALPROVISIONS
• Defines the scope and purpose of RDC 17/2010
• Minimum GMP requirements are establishment regarding
manufacturing medicinal products in and outside Brazil.
Methods not addressed in RDC 17/2010 resulting from
technical progress or the specific requirement still going.
• Medicinal products – REGISTERED AND PRODUCED ONLY BY
MANUFACTURES DULY LICENSED AND AUTHORIZED.
• Occupational health topics and environmental safety also
addressed.
5. QUALITYMANAGEMENT
WHO GMP guideline: the structure and its subdivision into a total of 17
chapters are identical. Regarding the subject matter presented in each
chapter, it is, however, structured differently.
The Brazilian guideline is written in the style of the legal document which
it is: each Article focuses on a single determination which can be
numerically referred to in inspection reports and subsequently
enforced if required.
6. Starting and intermediate materials out of specification must be
investigated and actions according to the CAPA procedure must be
taken.
Authorized person Technically
responsible person
Qualified person
Title II COMPLAINTS
7. STERILE PRODUCTS
(Titlefollows WHOdeterminationspublishedin2002,2010)
• Two topics (isolator technology, blow/fill/seal technology) added in RDC
17/2010
Reproduced, without any change, from the 2008 edition of Annex 1 to the EU GMP
guideline
• Guidelines for terminally sterilized products, RDC 17/2010 is stricter than WHO.
(NOT TAKEN FROM W.H.O)
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.
no exceptions are foreseen
unlike W.H.O
8. COMPUTER INFORMATIONSYSTEM
(OriginalEUGMPguidanceestablishedinAnnex11asabase)
• EXHAUSTIVE GUIDE PREPARED BY ANVISA IN CO-ORPORATION WITH
PROFESSIONALS OF ISPE, FOR VALIDATION OF COMPUTERISED
SYSTEM.
ISPE: International Society of Pharmaceutical
Engineers
• The concepts of risk management and electronic signatures are not
addressed in guideline.
9. HERBAL MEDICINE
(W.H.Oguidelinepublishedin2006)
• Guidelines regarding medicines of herbal origin only, , combination
products with those of animal or mineral origin are not addressed.
1. PROPER QA SYSTEM INSTALLED
2. ADEQUATE CONTROL ON MATERIAL
3. VALIDATED METHOLOGY
• Herbal raw material derivatives containing GMO must comply with
the specific standards.
10. CONCLUSION
This guideline comprises not only the generally applicable GMP
stipulations, but also covers a number of additional topics such as-
• sterile products
• biological and herbal products
• water for pharmaceutical use
• qualification and validation
11. • SUBPART
A -
SUBPART
B
• Chapter 1 General
Provisions
• Chapter 2 General Quality
System Requirements
• Chapter 3 Quality
Documents and Records
• Chapter 4 Design Control &
RMP
• Chapter 5 Process and
Production Controls
• Chapter 6 Handling, Storage,
Distribution and Traceability
• Chapter 7 Corrective and
Preventive Actions
• Chapter 8 Installation and
Servicing
• Chapter 9 Statistical
Techniques
• CLAUSE1-
CLAUSE 8
Editor's Notes
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.
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.
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.
This function is re- quired by law for all industrial companies operating in Brazil.
Title II requires complaints regarding falsified products and stolen cargo to be notified to the responsible health authorities.
WHO has since substituted them with a new edition published in 2010.
After sterlisation of products VERY STRINGENT, NO EXPECTIONS GIVEN.
GRADE C ------ cleanliness of their air, earlier versions (A to D) of Federal Standard 209-----Clean areas for carrying out less critical stages