Good Manufacturing Practices in Brazil

Good Manufacturing Practices in Brazil:

Anvisa RDC Resolution No. 16/2013,

similarities and differences compared to
ISO 13485:2016
Webinar Series on Medical Devices
Part I - ISO 13485 and the MDSAP Audit Model
Thibério Pires - 02/Jun/2021
Good Manufacturing Practices in Brazil: Anvisa Resolution RDC No. 16/2013, similarities and
differences compared to ISO 13485:2016
MERCOSUR COUNTRIES Source:

https://www.mercosur.int/pt-
br/quem-somos/paises-do-
mercosul/
Mercosur
Anvisa in Mercosur
Sub-working groups in Brazil
- SGT Nº 3 “Technical Regulations and Conformity Assessment”
- SGT Nº 11 “Health”
- Both linked to the Common Market Group (CMG).
Mercosur
SGT No. 3 is tasked with harmonizing Technical Regulations and Conformity Assessment
Procedures, also with coordinating actions related to the industrial and agricultural
sectors, and Anvisa’s topics are dealt with in the Food Commission and temporary
Working Groups with specific mandates. Face-to-face meetings are held twice a
semester.
Mercosur
SGT No. 11 has the general task of harmonizing laws and guidelines, promoting
technical cooperation and coordinating actions related to health, goods, services, raw
materials and health products (all of those regulated by Anvisa, except for food),
professional practice, epidemiological surveillance and health control. Anvisa’s topics
are addressed by the Health Surveillance Commission and its PAF Health Control
Subcommittee; at the Health Care Services Commission and its Subcommittee on the
Evaluation and Use of Technologies in Health Services; in the Committee on Sanitary
Products - its Subcommittees (Psychotropic and Narcotic, Pharmacopoeia, Medical,
Cosmetic and Sanitizing Products) and temporary Working Groups. Face-to-face
meetings are held once a semester.
Mercosur
There is also an active participation of Anvisa in the field of the Committees of the
Meeting of Ministers of Health dealing with the International Health Regulations,
Donations and Transplants, Blood and Blood Products, as well as Tobacco Products.
Resolution RDC No. 16 of 28 March 2013
In Brazil, the RESOLUTION OF THE COLLEGIATE COUNCIL OF ANVISA - DRC No. 16 of 28

MARCH 2013 (available in http://antigo.anvisa.gov.br/legislacao#/visualizar/29010)
approves the Technical Regulations on Good Manufacturing Practices for Medical
Products, In vitro Diagnostics.
Considering the need to internalize the MERCOSUR / GMC / RES Resolution. No. 20/11,
which approved the "Technical Regulation for Good Manufacturing Practices of Medical
Products and Diagnostic Products for In Vitro Use of MERCOSUR".
Resolution RDC No. 183 of 19 October 2017
Article 4 All Processes for Certification of Good Manufacturing Practices referred to by this Resolution
shall be accompanied by the following documents:
...
X - copy of the most recent inspection or audit report issued by the health authority of the country of
origin or by a third organization accredited by the latter;
XI - copy of the most recent inspection or audit report issued by the health authority of a member
country of the International Medical Device Regulators Forum (IMDRF) or by a third organization
accredited by it, when required; and
XII - copy of the most recent audit report issued by an external auditing organization that has been
recognized by Anvisa, when required
• Some of the reports are issued with reference to ISO 13485:2016, although Anvisa evaluates the
reports considering compliance with DRC 16/2013.
Resolution RDC No. 16 of 28 March 2013
CHAPTER 1 – GENERAL DISPOSITIONS CHAPTER 6 – HANDLING, STORAGE, DISTRIBUTION AND

CHAPTER 2 – GENERAL REQUIREMENTS OF THE TRACKING
QUALITY SYSTEM 6.1. Handling / 6.2. Storage / 6.3. Distribution / 6.4. Identification and tracking /
6.5. Non-complaint components and products
2.1. General Dispositions / 2.2. Management Responsibility / 2.3. Staff / 2.4.
Risk Management / 2.5. Purchasing Control CHAPTER 7 – CORRECTIVE AND PREVENTIVE ACTIONS
CHAPTER 3 – QUALITY DOCUMENTS AND RECORDS 7.1. Corrective and Preventing Actions / 7.2. Complaint Management / 7.3.
Quality Audit
3.1. General Requirements / 3.2. Historical record of the product / 3.3.
Inspections and test records CHAPTER 8 – INSTALLATION AND TECHNICAL
CHAPTER 4 – DESIGN CONTROL AND PRODUCT ASSISTANCE
8.1. Installation / 8.2. Technical Assistance
MASTER FILE
4.1. Design Control / 4.2. Product Master File CHAPTER 9 – STATISTICAL TECHNIQUES
CHAPTER 5 – PROCESS AND PRODUCTION CONTROLS
5.1. General Instructions / 5.2. Packing Controls, labeling and instructions for
use / 5.3. Inspections and tests / 5.4. Inspection, measuring and testing
equipment / 5.5. Validation / 5.6 Change control
ABNT NBR ISO 13485:2016 (Brazil)
Sanitary products - Quality management systems - Requirements for regulatory purposes
1. Scope 6.1. Provision of Resources / 6.2. Human resources / 6.3. Infrastructure / 6.4.
Working environment and contamination control / 6.4.1. Working environment
2. Regulatory reference / 6.4.2. Contamination control
3. Terms and definitions 7. Product realization
4. Quality Management System 7.1. Planning the realization of the product
4.1. General Requirements / 4.2. Documenting Requirements / 4.2.1. General / 7.2. Customer-related processes
4.2.2. Quality Manual / 4.2.3. Sanitary Products Records / 4.2.4. Documents
7.2.1. Determination of product-related requirements 7.2.2. Critical analysis of
Control / 4.2.5. Records Control
product-related requirements / 7.2.3. Communication
5. Management responsibility 7.3. Design and development
5.1. Management Commitment / 5.2. Customer focus / 5.3. Quality Policy / 5.4.
Planning / 5.4.1. Quality objectives / 5.4.2. Quality management system plan / 7.3.1. General / 7.3.2. Project Planning & Development / 7.3.3. Inputs for design
5.5. Responsibility, Authority and Communication / 5.5.1. Responsibility and and development / 7.3.4. Design and Development By-products / 7.3.5. Critical
Authority / 5.5.2. Top Management Representative / 5.5.3. Internal Design and Development Analysis / 7.3.6. Design and Development Verification
/ 7.3.7. Design and Development Validation / 7.3.8. Project and Development
communication / 5.6. Critical analysis by top management / 5.6.1. General /
Transfer / 7.3.9. Control of design and development changes / 7.3.10. Design
5.6.2. Critical Analysis Entries / 5.6.3. Critical analysis outputs
and development
6. Resources Management
ABNT NBR ISO 13485:2016 (Brazil)
Sanitary products - Quality management systems - Requirements for regulatory purposes
7.4. Procurement
7.4.1. Procurement process / 7.4.2. Procurement information / 7.4.3. 8. Measurement, analysis and improvement
Verification of the purchased product
7.5. Production and provision of services 8.1. General
7.5.1. Production control and provision of services / 7.5.2. Cleaning of the 8.2. Monitoring and measurement
product / 7.5.3. Installation Activities / 7.5.4. Technical assistance activities / 8.2.1. Feedback / 8.2.2. Complaints Management / 8.2.3. Notification to
7.5.5. Specific requirements for sterile sanitary products / 7.5.6. Validation of regulatory authorities / 8.2.4. Internal Audit / 8.2.5. Process monitoring and
production processes and provision of services / 7.5.7. Specific requirements measurement / 8.2.6. Product tracking and measurement
for validation of sterilization processes and sterile barrier systems / 7.5.8.
Identification / 7.5.9. Traceability / 7.5.10. Customer Property / 7.5.11. Product
8.3. Non-compliant product control
preservation 8.3.1. General / 8.3.2 Actions in response to the non-compliant product
detected prior to delivery / 8.3.3 Actions in response to the non-compliant
7.6. Control of monitoring and measurement product detected after delivery / 8.3.4 Rework
equipment 8.4. Data analysis
8.5. Improvement
8.5.1. General / 8.5.2. Corrective action / 8.5.3. Preventive Action
Comparison between ABNT NBR ISO 13485: 2016 and Resolution RDC No. 16/2013
Differences:
• Chapter organization;
• Requirements details.
Examples of additional requirements in DRC 16/2013:

• Pest control;
• Formalization of sampling plans;
• Records of training of service providers and consultants.
Pest control
5.1.3.4. Contamination control. Each manufacturer should establish and maintain

procedures to prevent contamination of equipment, components, manufacturing
materials, intermediate products and finished products with cleaning and disinfection
materials, including hazardous substances or contaminants generated by the
manufacturing process. A pest control program should be established and whenever
chemical agents are used, the company must ensure that they do not affect the quality
of the product.
Formalization of sampling plans
9.2. Sampling plans should be formalized in writing and based on valid statistical logic.
Each manufacturer should establish and maintain procedures to ensure that sampling
methods are suitable for their intended use and that they are periodically revised. The
revision of sampling plans should consider the occurrence of product nonconformities,
quality audit reports, complaints and other indicators.
Records of training of service providers and consultants
2.3.3. Consultants. Each manufacturer shall ensure that any consultant advising on the
methods used or on the controls used for the design, purchase, manufacture,
packaging, labelling, storage, installation or technical assistance of products has
sufficient qualifications (instruction, training and experience) to advise on the matters
for which it was contracted for. The recruitment of consultants shall be carried out in
accordance with the purchasing control requirements provided for in this Technical
Regulation.
The Medical Device Single Audit Program

(MDSAP) is based on: ISO 13485: 2016
(international), TG (MD) R Sch3 (Australia),
RDC Resolution ANVISA 16/2013 (Brazil),
MHLW Ordinance No. 169 (Japan), 21 CFR
Part 820 (United States) and the specific
requirements of medical device regulatory
authorities participating in the MDSAP
program.
Full details of the requirements established

by Resolution RDC No. 16/2013, in addition
to the requirements of ISO 13485:2016,
can be found in MDSAP AUDIT APPROACH,
Document No: MDSAP AU P0002.006,
Revision Date : 2021-04-01, available at
https://www.fda.gov/medical-
devices/medical-device-single-audit-
program-mdsap/mdsap-audit-procedures-
and-forms
Obrigado!
¡Gracias!
Thank you!
Coordination of Sanitary Inspection and Inspection of

Health Products(CPROD)
[email protected]
National Health Surveillance Agency - Anvisa

SIA Trecho 5 - Área especial 57 - Lote 200
CEP: 71205-050
Brasília - DF
https://www.gov.br/anvisa/pt-br
www.twitter.com/anvisa_oficial
Anvisa Meets: 0800-642-9782
[email protected]

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Good Manufacturing Practices in Brazil:

Anvisa RDC Resolution No. 16/2013,

MERCOSUR COUNTRIES Source:

In Brazil, the RESOLUTION OF THE COLLEGIATE COUNCIL OF ANVISA - DRC No. 16 of 28

CHAPTER 1 – GENERAL DISPOSITIONS CHAPTER 6 – HANDLING, STORAGE, DISTRIBUTION AND

Examples of additional requirements in DRC 16/2013:

5.1.3.4. Contamination control. Each manufacturer should establish and maintain

Formalization of sampling plans

Records of training of service providers and consultants

The Medical Device Single Audit Program

Full details of the requirements established

Coordination of Sanitary Inspection and Inspection of

National Health Surveillance Agency - Anvisa

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