Brazilian legislation (Anvisa) provides guidance on the qualification of the transportation of active biological ingredients, biological products in bulk, biological products in their primary packaging and finished biological products, establishing the minimum requirements to be met for this purpose.


The main purpose of thermal qualification for the transportation of time- and temperature-sensitive products is to provide technical data proving the thermal performance of a given package. It is currently being demanded more and more by Health Surveillance and the entire chain involved.

Only through these studies is it possible to establish a quality standard that meets the needs of the entire drug cold chain and preserves its characteristics.

Thermal packaging qualification studies seek to analyze the behavior of each load in different situations, such as high variations in external temperature, as well as showing the amount of ice (suitable for this purpose) required for each package.

Qualification Stages required by Anvisa:

Operation Qualification (OQ): The operating qualification is a simulation of the worst temperature conditions to which the products could be subjected under real transportation conditions.

  • It is characterized by actions that establish, under controlled conditions (by a climatic chamber in a laboratory),
  • It can be carried out with the product or with representative samples of the product, as long as the thermal mass is preserved.
  • Sufficient temperature recorders must be used to assess which critical points in the transport system are most susceptible to temperature variations.

Performance Qualification (QP): Performance qualification is documented evidence that a thermal package has been designed in accordance with the acceptance criteria and the requirements of Good Transport Practice

  • Sending the thermal packaging along the critical routes, considered to be the worst cases for sending temperature-sensitive products (winter and summer), according to the transport characteristics of the establishment to demonstrate that the packaging is effective, robust, and reproducible.
  • The internal temperature monitors must be located at those points assessed as most critical during operation qualifications, according to the volume of the system and the amount of cargo.
  • The external temperature must be monitored throughout transportation by at least one monitor.
  • The type, number, size, location and quantity and conditioning conditions of the refrigerant material used in this qualification must be the same as those used in the operation qualification.
  • Three shipments are the minimum number considered and recommended for drawing up the performance qualification protocol.

Anvisa's Requirements at the End of the Qualification Process

  • Report with graphs and tables proving the effectiveness of the thermal packaging tested.
  • Quantity of cooling elements ideal for thermal maintenance
  • Specifications of each packaging material, among other technical data necessary to accredit the study carried out.


Preparing and submitting to Anvisa a complete Report required by Brazilian legislation for Transport Qualification is feasible and highly recommended to enter the Brazilian market without any problems, but the company must be a qualified Brazilian company with the correct licenses.

Brochure : GRP Brazil Services

GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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