Meet the requirements of RDC 430 for the pharmaceutical industry
For entrepreneurs working in the pharmaceutical industry it is important that they are always aligned with the latest resolutions in this sector. Here, on the Blog of Kivalita Consulting, we will clarify some of the main requirements of RDC 430 (Resolution of the Collegiate Board), published in October 2020.
This resolution aims to ensure the best practices of distribution and storage of the transport of medicines, including raw materials. More than that, RDC 430 aims to ensure the quality of pharmaceutical products manufactured in our country, not only in transportation for its internal commercialization, but also for them to be able to export and, therefore, to meet the demands of the global market.
Attention to good practice in the distribution and storage of pharmaceutical transport
RDC430/20 highlights the need to respect good practices in the distribution and storage of the movement of pharmaceutical products, which includes transport by ship, aircraft and other vehicles.
Factors such as temperature, humidity, ventilation and lighting of the storage site should be constantly monitored in order to ensure the quality of medicines, especially those more sensitive.
In fact, all agents of the logistics chain need to be attentive to each of these points when storing and transporting products in their localities. And for outsourcing cases, the resolution is clear by requiring such attributions and responsibilities by both parties: contractor and contractor.
The temperature, for example, should be controlled throughout the transport of the medicine to ensure thermal homogeneity inside. Here, the adoption of automation technologies either in the manufacturer’s facilities, in distribution channels and by logistics service providers, even in institutions where the drug will be administered to the patient, will certainly make this monitoring more agile and accurate.
This is because relevant data can be shared in real time with managers, who will have more visibility into the distribution and storage in the transportation of these products. Similarly, those involved in the chain may be better prepared to deal with possible failures, taking quick actions to repair them and avoid majorlosses or impacts that affect the quality of the products transported.
In this sense, automation can help in monitoring and controlling the temperature by emitting alarms capable of signaling unexpected occurrences, which require urgent action. However, any technological resource that assists this temperature measurement must be based on thermal validation studies. Finally, it is essential to remember that stock movements must be planned in advance, to reduce such temperature variations as much as possible.
It is also important to highlight that any installation, system and equipment included in the process of distribution and storage of transport of medicines also require proper thermal validation.
Attention to updates on the dry and cold chain thermal validation study
By following the good practices of RDC 430/20,your company collaborates to certify the credibility of its drug storage and transportation system, preventing products from being labeled as counterfeit, disapproved, illegally imported, stolen, damaged and/or tampered with. Failure to comply with the provisions included in this resolution may also result in a health violation to the manufacturer, as determined by law.
The thermal validation study for the transport of medicines should consider the type of modal (air, road or sea), route time, type of product and the risk analysis developed for the study. To give an overview of the documentation a quality specialist needs to generate for this study, see the diagram below:
For this and other reasons, we always recommend that you be aware of the changes that may occur in resolutions and require significant adjustments in the manufacturing cycle and quality management of your industry products. Of course, we will share with you every new update of this and other resolutions. Follow our blog!
If your company operates in other industries in the LifeScience sector, such as pharmacochemical, cosmetic, food, veterinary, among others, besides pharmaceutical, know that Kivalita Consulting can support you to be always up to date with the most complex requirements of resolutions inherent in the quality management of your products.
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