By Barbara Guelfi, CEO and Founder of Kivalita Consulting
Resolution 653/2022 has achanged, repealed and added some important questions about RDC 430/2020 on Good Practices in The Distribution, Storage and Transport of Medicines.
The changed or added topics are respectively:
- Art. 64: Art. 64 – Item V, chapters -1st, 2nd, 3rd, 4th and 5th
- Art. 89: Chapters 1st and 2nd
What has changed from RDC 653/2022 to RDC 430/2020?
Previously in RDC 430/2020 – Art. 64 item V – there were only specifications on restricted access to the drug in transportation, but it does not specify who.
Today at RDC 653/2022 – Art. 64 -Incise V – It is now possible to provide restrictive access to authorized and trained personnel.
Previously in RDC 430/2020 – Art. 64 Chapter 1 – It was only without the control of temperature and humidity, when the transport conditions were qualified.
Today at RDC 653/2022 – Art. 64 Chapter 1 – The control of passive and active systems of temperature and humidity control for sanitary control or other reasons, can be eliminated when there is use of qualified transport conditions or technically justified by the manufacturer.
Previously in RDC 430/2020 – Carriers had no need to do risk analysis for variable impacts on routes other than those defined in the records, this chapter did not exist and was added in the new RDC.
Today in RDC 653/2022 – Art. 64 Chapter 3 – A risk assessment should be carried out to consider the impact of the variables of the transport process that is not continuously controlled or monitored, as well as for the quality control of products if they are transported under conditions different from those defined in the records.
Previously in RDC 430/2020 – The monitoring of variables was constantly updated by equipment calibrated during routes, and there could be no other process that would replace this monitoring, this chapter did not exist and was added to the new RDC.
Today at RDC 653/2022 – Art. 64 Chapter 4 – The monitoring provided for transport conditions related to temperature, packaging, storage and humidity specifications of the drug using calibrated instruments can occur periodically on routes defined as worst cases after a risk analysis that considers similarity of routes, climatological data, weather and distance, seasonality, transportation modals, schedules, and other critical variables for transportation.
Previously in RDC 430/2020 – There could be the elimination of monitoring of humidity and temperature in transport, in adverse conditions to the product registration, this chapter was added to the new RDC.
Today at RDC 653/2022 – Art. 64 Chapter 5 – Humidity and temperature control can be eliminated after risk assessment or when technical justifications are presented by manufacturers who support transportation under adverse conditions as defined in the registry.
Previously in RDC 430/2020 – It was stipulated 1 year for implementation of the set of actions of Article 64, which would have already expired on 16/03/2022.
Today in RDC 653/2022 – Art. 89 – The period of 3 years is established from the date of entry into force of resolution No. 653/2022 (30/03/2022) for the application of the set of actions that will be necessary for the implementation of the defendant in paragraphs II and III of Art. 64.
Previously in RDC 430/2020 – It was considered the same period of 1 year indicated in art. 89, which would have expired on 16/03/2022.
Today in RDC 653/2022 – Art. 89 chapter 1 – The deadline of 2 years is established from the date of effective date of RDC No653/2022 (30/03/2022) so that all links in the distribution chain carry out their studies of route mappings.
Previously in RDC 430/2020 – The results obtained, even if outside the acceptance range, were not considered infractions to the requirements, if they were the integrity and quality of the product, but now actions are needed to regularize the results obtained.
Today in RDC 653/2022 – Art. 89 º 2 – After the deadline established in Item 1, companies will have 1 year to implement the applicable solutions taking into account the results obtained in route mapping studies or risk analysis.
Chapter 64 of Article 64 in the former RDC 430/2020 was repealed by the new RDC 653/2022.
Finally, the new RDC came to give more time for adjustments to be made and enabled other adaptation paths for carriers. On the other hand, it promoted much more the need for risk analysis and application of the necessary solutions.
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