Redator Kivalita em 2 de May de 2022 em Articles

Compare the differences between RDC 301/2019 and the new RDC 658/2022 for the pharmaceutical industry

Conheça as diferenças entre a RDC 301/2019 e a nova RDC 658/2022 para indústria farmacêutica - Interno 1 | Kivalita Consulting

By Bárbara Guelfi (founder and CEO of Kivalita Consulting)

The new RDC 658/2022 was recently published on March 31st this year and it is expected to enter into force on 5/2/2022. The new one replaces the RDC 301/2019 focus on the Best Manufacturing Practices (BMP) for the pharmaceutical products.  It surprised the pharmaceutical manufacturers – and the entire LifeSciences market – once they will face many challenges ahead, including in the short term, the adaptation of their manufacturing plants according to the new requirements forced by the new resolution.

It is important to understand all these changes, as the announcement of the new RDC 658/2022 was made just after Anvisa has been approved to be part of the PIC/S (Pharmaceutical Inspection Co-operation Scheme). Therefore, Anvisa now counts with international recognition of excellence for the Best Manufacturing Practices (BMP) inspections of medicines and pharmaceutical products for human use.

It also provides greater support for the local pharmaceutical products manufacturers that want to export their products, once it can generate more opportunities in international markets considering a globally recognized BMP certification.

In this article, we would like to clarify some of the main differences, which were amended and repealed with the introduction of the new RDC 658/2022 – which, moreover, accompanies the new rules of the PIC/S. Check them!

  • Risk management:  it is important to highlight that risk management continues to be mentioned several times across the legislation, therefore, it needs to be done through a system of risk correction and prevention, as well as the actions of improvements must be implemented and their effectiveness duly proven.
  • Process standardization: parametersmust be analyzed and verified to ensure consistency with each other.                                
  •  International audits: the article 181 (Item VII) from the new RDC 658/2022 establishes that audits (whether national or international suppliers) need to be provided on a regular basis, according to analysis and risk management inherent to manufacturing processes. This forecast of audits, with intervals defined by the Quality Risk Management process, aims to ensure the maintenance of standards and continuous use of the approved supply chain. 
  • Vision systems: companies with legacy software should adapt them to new requirements with a focus on implementing vision systems to ensure traceability of the product packaging. In this case, the new RDC 658/2022 details deadlines (including retroactive ones), for which manufacturers should pay attention to the software planning, selection of suppliers, training and implementation.

Deadlines for adjustments, according to new RDC 658/2022

– Article 367 – Outsourced Activities Management

The need for processes, which ensure the management of outsourced activities within the QMS (Quality Management System), came into force on April 7th, 2020.

– Article 368 – Periodic Review

On January 7th, 2020 started therequirement for a periodic review, involving the company’s management of the QMS to ensure continuous improvement of products, processes and systems, came into force.

– Article 370 – Risk Management Results

April 7th, 2020 – Companies must have already completed the (re) structuring/integrations of their Pharmaceutical Quality and Risk Management Systems; trained their employees; identified, hired and trained qualified services/professionals.

October 7th, 2020 – Companies must have already fully met the new regulatory requirement for the introduction of any products (commercial and experimental) in the production lines.

October 7th, 2021 – Manufacturers must have fully met the new regulatory requirement for 30% of all products in the portfolio (both commercial and experimental);

October 7th, 2022 – Pharmaceutical companies must have fully met the new regulatory requirement for 60% of all products in the portfolio (commercial and experimental).

October 7th, 2023 – Companies must have fully met the new regulatory requirement for 100% of all products in the portfolio (both commercial and experimental);

– Article 179 – Legacy Products

It was also set the date of October 7, 2020, to take effect on the legacy products (i.e. those already registered).

Article 372 – Online Control of Product Packaging

By October 7th, 2024, online product control during the packaging process should include checking the appearance, materials used, printing, and correct operation of the line.

In relation to this article 372, there are proofs that must be made with respect to the validation of the system:

October 7th, 2020 – the elaboration of User Requirements Specification (URS) and prospecting manufacturers must have already been carried out, in addition to the purchasing confirmation. April 7th, 2021 – the selection of the manufacturer and the Qualification of the Design must have already been carried out.

April 7th, 2021 – the manufacturer’s selection and design qualification must have already been made. 

October 7th, 2024 – other stages of equipment qualification needed for the operation – according to the Article 215 (regarding the online control of the product during packaging) – and its start as part of the routine operation must be carried out.

Kivalita Consulting’s eBook provides you more details on differences

Here, we talk briefly about some of the major changes. However, do you know that there are, for example, regulatory requirements for articles contained in the new resolution, which do not apply to the medical gas companies?

Our professionals from Kivalita Consulting have prepared a special e-book that provides you more details on this topic and others related to the changes with the new resolution, such as the INs have been repealed, changed or replaced from the new legislation and the list of the new standards (RDCs), as well as those that have been replaced.

Kivalita Consulting’s proposal is to support pharmaceutical products manufacturers to face the challenges related to Best Manufacturing Practices, starting with the new RDC 658/2022.

To download Kivalita Consulting’s e-book “Know the differences between RDC658 x RDC 301 and how to adapt your business”, which is available in Portuguese only, please visit this link:

You can also watch a live video (in Portuguese) on this topic on kivalita consulting’s You Tube Channel

Our experts are also available to help you and talk about it. 

Schedule a virtual meeting with us! It will be a pleasure to meet you!

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