Brazilian Regulations – Changes to Temperature and Humidity Requirements
Preparation for new stringent requirements
Most pharmaceutical companies that have ever shipped and/or distributed products within Brazil know that the Brazilian Good Distribution Practices and Import regulations from ANVISA, the Brazilian Health Authority, are among the strictest in the world. Two recent regulations (RDC 304 & 360) are adding new and even more stringent requirements. Temperature and humidity monitoring will become mandatory on March 17, 2021, making it necessary to start preparing now.
RDC 304 was published on September 17, 2019, with the aim to create greater controls in the drug manufacturing process. This in turn would ensure improved drug quality during the stages of distribution, storage, handling and transportation. The main changes proposed by ANVISA, include requirements for:
- Implementation of a Quality Management System
- Expansion of principles for good distribution practices for distributors and carriers
- Additional new and very clear requirements for including humidity in the various risk assessments and environmental monitoring required
RDC 360 was published on April 6, 2020, which was an amendment to the original regulation. It clarifies the implementation period and extends the length of time for condition monitoring rule with the exemption for transportation if the shipment is under a certain number of hours. It originally stated the length of time for monitoring the in-transit shipment was required for shipments greater than four (4) hours and now has been extended to requiring monitoring for greater than shipments of eight (8) hours. This however, is under very strict documented conditions (a documented preliminary risk assessment and use of qualified shippers).
Some examples of these requirements include:
“Article 43. The storage areas must be equipped with equipment and instruments necessary to control and monitor the required temperature and humidity.
- §1. Monitoring shall be performed by instruments positioned in accordance with the thermal qualification study of the area.
- §2. The reading of the instruments, if performed intermittently, shall correspond to the periods of greatest criticality.
- §3. Monitoring shall be recorded, and records shall be kept for at least two years after its generation.
- §4. The instruments must be calibrated before their first use and at defined intervals and justified by the instrument performance and measurement sensitivity”
“Article 64. The obligations of the companies that carry the transportation of medicines are:
- have the cargo manifest carried with the expected landing on board the carrier vehicle;
- monitor transportation conditions related to temperature specifications, drug packaging, storage and moisture using calibrated instruments…”
“Article 84. The monitoring and control of the temperature during storage and transportation must be carried out.
- §1. Temperature monitoring and control should preferably be carried out by means of computerized supervisory systems.
- §2. The position of temperature measuring instruments shall be subsidized by studies of thermal qualification.”
It is important to understand that in Article 84 is focused on equipment and storage areas used for the explicit storage and transportation of medicines should be qualified/validated prior to use and the results of these risk assessments should identify the weaker points. In order to capture the worst case scenarios these weak points are the locations where the measuring instruments should be placed.
There are only a few countries in the world (Brazil, South Africa, and Saudi Arabia) that explicitly mention or require monitoring of humidity. In the case of Brazil, companies will have to prove and document that humidity (in addition to temperature) does not have any impact on product quality or integrity by conducting risk assessments such as Lane, Packaging, and Storage Area Qualifications , even for products that in principle should not be affected by it, such as Controlled Room Temperature products.
The implementation time of 18 months started from the original publication date, which means that monitoring of temperature and humidity will become mandatory on March 17, 2021. With less than a year away, now would be a good time to begin to start thinking about risk assessments, which should be done based on more extreme conditions in the summer and the winter. Consequently, it is important to plan to be able to meet the regulatory requirements and start early.
Sensitech Inc., with its extensive datalogger portfolio helping companies to monitor temperature and humidity, has also assisted many companies to understand what type of product protection is needed by lane and season to meet regulatory requirements with deep professional services expertise. To learn more about these new Brazilian regulatory changes and how they may affect your supply chain compliance, contact one of our Sensitech experts today.