Agência Nacional de Vigilância Sanitária – ANVISA is the Regulatory Body of Brazilian government.
What is Good Manufacturing Practice (GMP)?
Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices.
The GMP document released on 30th March 2022 for Medical and IVD products replaced the GMP document released by ANVISA in 2013. In this article, we will discuss the Significant changes that were made in the latest 2022 Regulations, which supersedes the 2013 version.
- In Art 35 2022 GMP Document, under the document review and archive section, it is explicitly mentioned that – “All digitally stored documents and records shall be backed up.”
- In Art 71 2022 GMP Document, under the Personal health and hygiene section, it is now clearly explained that – “Any individual who, upon medical examination or observation by supervisors, appears to be in a health condition which could affect the product shall be removed from operations until the health condition is deemed adequate.”
- In Art 87 2022 GMP Document under labels and instructions for use, there is an additional point which states – “In the case of importers, the approval documentation referred to in “Labels and instructions for use” article may be recorded in a specific document in lieu of the history record of the product.”
- In Art 112 2022 GMP Document under Distribution Records section, it is now mentioned as:
Each manufacturer shall maintain distribution records which include or reference:
I – the name and address of the consignee.
II – risk: combination of probability of occurrence and severity of damage.
III – any number control used for traceability.
Previously in the 2013 GMP document, it was mentioned as:
Each manufacturer shall maintain distribution records, including or making reference to:
(i)Names and addresses of the consignee;
(ii) Identification and amount of products shipped, with shipment date;
(iii) Any numerical control used for traceability.
- In Art 114 2022 GMP Document under Identification and traceability of batch production units’ section, there is an additional point added which states- “Each manufacturer shall establish and maintain a program for maintenance, adjustment and, where necessary, cleaning of equipment to ensure that all manufacturing specifications are met.” This is in addition to the identification of the units that are manufactured with every product history record.
- In Art 118 2022 GMP Document, under the Non-conforming components and products section, there is an additional point added which states – “The disposal of the products referred to as “non-conforming” shall be documented, and a record of the justification and manual or electronic signature of the person-in-charge for the disposal of such non-conforming products or components shall be kept.”
- In Art 120-VIII 2022 GMP Document, under the Corrective and preventive actions section, there is additional information added which states – Each manufacturer shall establish and maintain procedures to determine the collection of products and other field actions for those products that are already distributed. The quality process to determine the corrective actions in regard to the identified potential causes shall be based on a valid statistical technique for detecting recurring quality problems, where applicable.”
- In Art 123 2022 GMP Document under the Quality Audit section, there is an additional point added which states – “Those in charge of conducting the quality audit cannot be directly responsible for the matters under audit.”
- CHAPTER 10 in 2022 GMP Document (Final Provisions) is additionally introduced – The chapter includes rules such as:
- “The documentation evidencing compliance with the requirements set out in this Resolution shall be made available whenever requested by the health regulatory agencies.”
- “Failure to comply with the provisions contained in this Resolution constitutes a health violation, under the terms of Law No. 6.437, of August 20, 1977, without prejudice to applicable civil, administrative and criminal liabilities”
- “The following are hereby revoked:
I – the Resolution of the Collegiate Board of Directors – RDC No. 16, of March 28, 2013, published in the Federal Official Journal No. 61, of April 1, 2013, Section 1, p. 75;
II – Normative Instruction – IN No. 8, of December 26, 2013, published in the Federal Official Journal No. 252, of December 30, 2013, Section 1, p. 758.”
When will this Resolution come into effect?
This Resolution comes into force on May 2, 2022.
What are the terms that got replaced in the new document?
|Device history record||Product history record|
|Device Master Record (DMR)||Product Master Record (RMP)|