Published on March 30, 2022 by Anvisa’s Collegiate Board, RDC 658 provides the general guidelines for Good Manufacturing Practices (GMP) for Medicines. The publication revoked the previous resolution of 2019, which was already a milestone for the category.
In practice, RDC 658/22 does not modify the understanding of the guidelines defined in the 2019 resolution. It improved the spelling and overall structure of the text and simplified some definitions. In addition, this Resolution of the Collegiate Board defined transitoriness, such as, for example, the deadline for the implementation of online control in packaging lines.
What is RDC 658/22?
This document aims to make Brazilian manufacturers able to access markets more easily through the Pharmaceutical Inspection Cooperation Scheme (PIC/S). In this way, this sector has increased exports and becomes more competitive.
RDC 658 is the main regulatory standard for drug manufacturers. Within the Resolution, there is the determination of all the minimum requirements related to the production of medicines in the following aspects:
- Production,
- Quality Control,
- Documentation
- Training
- Packing
- Facilities
- Storage.
The main questions about RDC 658/22
For you to know everything about RDC No. 658, we have prepared all the answers to the main questions on the subject, which is so important for the pharmaceutical industry. Check it out below!
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To whom does RDC 658/22 apply?
This Resolution of the Collegiate Board applies to companies that carry out operations involved in the manufacture of medicines. This includes experimental drugs (those manufactured for use in clinical trials).
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What were the resolutions revoked with the publication of RDC 658/22?
As described in Article 379, the revoked resolutions were:
- Collegiate Board Resolution – RDC No. 301, of August 21, 2019;
- Collegiate Board Resolution – RDC No. 388, of May 26, 2020;
- Collegiate Board Resolution – RDC No. 580, of November 26, 2021.
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When did RDC 658/22 come into force?
As determined in Article 380, RDC 658/22 entered into force on May 2, 2022.
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After the resolution comes into force, is there any deadline for action for companies to comply with all the requirements of the resolution?
Yes. Some requirements have already been put into effect and, for others, deadlines have been stipulated according to the complexity of their adequacy. In general, the furthest deadline for the obligation is October 7, 2024.
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What is the responsibility of the Operating Authorization holder when manufacturing a medicine?
The registration holder must manufacture medicines in a way that ensures that they correspond to the intended purpose.
In addition, it needs to ensure that they meet the requirements of the registration/authorization for clinical trial use, as appropriate, without putting patient safety at risk due to inadequate quality or efficacy.
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What are the means to achieve quality, safety, and satisfaction when manufacturing a drug?
To reliably achieve this quality goal, there must be a comprehensive and correctly implemented Pharmaceutical Quality System. It also needs to incorporate the Good Manufacturing Practices and Quality Risk Management indicated in the RDC.
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What are the parties involved in the Pharmaceutical Quality System and its essential needs?
Compliance with the quality objective is the responsibility of the company’s upper management. It requires the participation and commitment of the team at all levels of the organization. This is true even for its suppliers and distributors.
According to Article 8 of RDC 658-22, a Pharmaceutical Quality System must ensure, among other items mentioned in the resolution, the following requirements:
- Create and maintain effective systems for monitoring and controlling production and quality performance;
- Investigate at an appropriate level the causes of deviations, nonconformities, suspected defects and other problems;
- Have a self-inspection or quality audit process that regularly evaluates the effectiveness and applicability of the Pharmaceutical Quality System (Art. 8, XVII).
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To which steps do Good Manufacturing Practices (GMP) apply?
Good Manufacturing Practices concern both production and quality control.
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Documentation is an essential part of the Quality Management System. So, what are the ways to document industrial processes?
Documentation can exist in a variety of forms, including print, electronic, or even photographic media. Regardless of the system used, the important thing is to establish, control, monitor and record all activities that affect the quality of medicines.
Also, remember that complex systems need to be understood, well documented, and validated, with proper controls present.
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What is a validation and when should it be performed?
Validation is the action of proving, under the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected results.
For this, it is necessary to carry out validation studies to reinforce Good Manufacturing Practices. They also need to be conducted according to procedures defined in the DRC.
In general, validations are performed on all critical systems with an impact on GMP. This may include new systems, certification of monitoring status of systems already implemented, as well as change control results, among others.
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Every marketed drug must be part of stability monitoring. What is the purpose of monitoring?
The purpose of the follow-up stability program is to monitor the product throughout its shelf life and determine if it remains within specifications under the storage conditions present on the label.
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What should be done when there is a suspicion of deviation from the quality of the product?
Appropriate procedures must be in place for filing, evaluating, investigating, and reviewing complaints. It also creates measures for the recall of medicines intended for human use (including experimental ones) effectively and immediately, in the event of quality deviations.
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When identifying deviations or non-conformities, what can be done to resolve and mitigate them?
You must establish a Corrective Action and Preventive Action (CAPA) system. It is a work process with several tools, both quality management and risk management. Its focus is on identifying, evaluating and investigating past events (deviations, non-conformities, etc.).
In CAPA, you need to define an action plan, the activities related to their implementation, and the verification of the effectiveness of these actions (corrective and preventive).
In addition, CAPA helps to correct the root cause of past events: deviations, non-conformities, etc. This prevents recurrences and prevents future events from occurring.
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If a change is identified, whether due to process improvement actions or of any other nature, how should I proceed?
For these cases, your QMS needs to have procedures in place for the prospective evaluation of planned changes and their approval prior to implementation, taking into account regulatory notifications and approvals where necessary.
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How should the distribution of products be carried out?
The distribution of products must minimize any risk to their quality and take into account the good distribution practices indicated in RDC 430, of October 8, 2020.
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RDC 658 provides for internal processes of self-inspection and/or quality audits. What is their purpose?
The audit regularly evaluates the effectiveness and applicability of the Pharmaceutical Quality System.
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In addition to internal audits, which audits in third-party activities should be carried out?
It is necessary to audit suppliers, such as manufacturers and distributors of inputs, to confirm that everything is under good manufacturing practices and the requirements of good distribution practices.
How SoftExpert solutions leverage RDC 658/22
Complying with the requirements of the resolution and establishing a state of control pose major challenges for pharmaceutical industries. The good news is that, with the support of technology, the whole process is simpler and faster.
For example, with SoftExpert Suite you have integrated management of compliance, innovation and digital transformation of the main aspects of RDC 658/22 in a single solution.
The platform has connected tools that promote collaborative work and replace several siloed management systems. This way you gain agility and efficiency, in addition to avoiding inconsistencies, errors and lack of visibility.
To help you achieve more efficiency and compliance in your operations, our experts can help you identify the best strategies for your company with SoftExpert solutions. Talk to us today!
