Redator Kivalita em 3 de May de 2021 em Articles

Dry Chain Thermal Validation: What you need to predict considering RDC 430/2020

There are countless questions from professionals working in the logistics area and mostly from industries that need to develop a thermal validation dry chain transport of their products. It became even bigger after the Resolution of the Collegiate Board – RDC No. 430 – which provides for storage good practices, medicines distribution and transport, which has entered into force since its publication in the D.O.U. on October 9, 2020, when there were important updates to be considered by all involved.

To make it easier, we’ve summing up the main points of change here and what quality experts and field professionals need to predict.

Important aspects about RDC 430

Art. 4 General Provisions Topic

“The principles of Good Practice should also be observed in reverse logistics.”

This reverse logistics is the return of the drug that has any kind of damage, because it is necessary to maintain the stability of the product.

Art. 15 SGQ

“Processes impact the quality of medicines and should be mapped…”

Good transport practices are a very important part because it is she who will ensure consumer safety, the success of logistics and quality of products produced as an all. There are several steps to be taken to ensure this topic.

Art. 25 Documentation

“Operating procedures and records shall be maintained for at least 5 years after obsolescence.”

Documentation is an essential part of the process and storage is required, so always aiming at innovation we indicate that they are stored in clouds added to another type of offline storage if there is physical documentation.

Art. 36 Returns

“Drugs that are the objects of theft, theft or other misappropriation must be rejected. “

This procedure is necessary because when subtracted the product leaves the necessary conditions to remain preserved and becomes no longer safe for consumption.

Art. 43 Storage facilities

“Equipment and instruments for controlling and monitoring temperature and humidity in storage areas, instruments must be calibrated. Records kept for at least 2 years.”

Equipment Calibration is a necessary practice to make sure that everything is being measured in an integrated manner. This calibration process is part of a validation of equipment that checks beyond this, other points of the equipment.

Art. 45 Storage facilities

“Installations with smooth surfaces, without cracks and without dust detachment.”

This specification exists so that there is no contamination by microorganisms that can develop in an environment that is not easily sterilized because of its structure.  

Art. 64 Transport and storage in transit

“Monitor transport conditions and control temperature and humidity”

It is part of the concerns to maintain the stability of the products throughout the transport, given that there is variation in temperature and humidity throughout the trip. Imagine that the truck comes out of the south and goes to the northeast, which is considerably warmer, the internal temperature and humidity of the truck has to remain the same.

Art. 70 Transportation and Storage in Transit

“Transport shared only after risk analysis completed as acceptable”

The risk analysis serves to predict what are the possible gaps that may arise with such sharing practice and already avoid them so that there is no contamination, leakage or reaction of the two loads in one environment.

Art. 77 Thermolabile

“Minimize exposure to room temperature during receipt and shipment total exposure time should be recorded.”

It is important for the driver to know some information about how long it is possible to expose the load at room temperature without instability and may generate risks for people, both for delivery of the product to the destination, and in the case of an unplanned exposure, such as an accident or failure in refrigeration systems etc.  

Art.79 Thermolabile

“In addition to the primary source of electricity, having an alternative source in storage”

Precisely to eliminate the risk of failures is already expected this action and minimize the risk of something flammable or toxic hitting a person.

 Art. 80 Thermolabile

“Have contingency plan in storage and transportation”

Emergency situations is one of the main risks to be considered because the moment of transport is where the cargo is sensitive to an uncontrolled environment, it is necessary to have contingency.

 Art.81 Thermolabile

“Have cooling emergency alternatives such as liquid nitrogen or dry ice. Part of the actions to avoid damage to those who expose themselves to the products. Updating and repealing legislation”

Updates on RDC 340/2020

There were important updates to be considered by all interested parties about this resolution comes revoke RDC 304 and its complementation, RDC 360.

The definition of return was included in RDC no. 430, as article XXXI of Art. 3: “return: return to the supplier drugs physically incorporated to the customer’s stock and, thus, entered the customer’s custody chain. These medicinal products, when returned to their origin, are with a tax document or corresponding document, other than the shipping document”.

It was also amended paragraph 2 of Art. 64 which says: “The mandatory temperature monitoring may be free when the maximum transport time is proven in the records as less than 8 (eight) hours – before, that time was 4 (hours) – this is carried out at the end point of dispensing the drug and thermal packaging is used that have a qualification consistent with the time and conditions of transport”.

Do you want to know if your company meets the new determinations of RDC 430?

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