Redator Kivalita em 19 de July de 2021 em Articles

GLP: What your lab needs to know about RDC 512/21

In this article, we will address the main points of RDC No 512 of 5/27/2021, which complements RDC 390/20. This Collegiate Board Resolution has “Good Practices for Quality Control Laboratories”, aiming at the definition of the principles and requirements for performing quality, reliability and safety analyses on laboratory products subject to Sanitary Surveillance.

Therefore, it is mandatory for laboratories to have an updated health license according to the sanitary legislation of their locality. In addition, this license must be fixed in a location visible to the public. This RDC applies to public or private laboratories, which perform analysis of products subject to Sanitary Surveillance, i.e., laboratories for analysis of pharmaceuticals, cosmetics, food, sanitizeants, among others.

RDC No 512/21 determines the application of corrective action in order to eliminate the cause of an identified non-conformity or any other undesirable situation; as well as preventive action to eliminate the cause of a potential non-compliance, any other potentially undesirable situation or even aimed at taking advantage of opportunities for improvement. All non-conformities, corrective actions and their respective monitoring and efficacy assessment actions should be recorded.

Attention to staff qualification

Another important requirement of this Collegiate Board Resolution is the fact that the laboratory has a technical officer, legally qualified and duly qualified to meet its scope, specificity and complexity of activity. This technician, for example, should be responsible for planning people and materials necessary for the development of activities, and for the execution of the analyses.

In addition, the laboratory also needs to designate a dedicated professional to act as technical responsible, according to Article 6 of RDC 512/21, in a manner aligned with its senior management, in the implementation and operation of a quality management system.

It is necessary to emphasize here, the need for the laboratory to offer a periodic training program suitable to its technicians – especially on biosafety procedures, through personnel under proven supervision. In fact, with regard to biosafety, a specific program is required for the execution, monitoring, control and verification of cleaning, disinfection and sterilization operations of surfaces, facilities, equipment, instruments and materials, as required in the analytical scope and in the procedures dedicated to this theme.

It is also essential to qualify, through periodic evaluations, of suppliers of equipment, materials, reagents, supplies, supplies, in short, of services that affect the quality of the analyses.

The role of leadership

Similarly, the implementation of a quality policy, infrastructure assurance and adequate conditions, as well as skilled labor and sufficient resources to carry out the activities are also among the requirements that must be ensured by the laboratory leaders. Not to mention the traceability of analytical results, procedures and evidence capable of preventing, minimizing or eliminating environmental damage – including people’s health – should also be considered by the leadership team.

Procedures for issuing documents

Among the determinations for documents issued by the laboratory, RDC No. 512/21 requires that all be approved, signed and dated by the designated responsible. Their versions must be updated and authorized, being readily available in the places where the activities are carried out, for the knowledge of the team. However, it is essential that they periodically go through critical analysis and that they are kept historical of their changes (for a time established in the internal norm of the laboratory, according to specific laws) and, if reproduced, must be faithful to the original document. For this, procedures are needed to ensure the protection, custody, recovery, transmission, integrity and confidentiality of records.

With regard to the presentation of the results, the laboratory must issue, forward or transmit the analytical reports and their copies, by physical and electronic means, and objectively, unequivocally, safely and confidentially. Documents revealing such results shall include a number of information specified in DrC 512/21, independent of others required in specific legislation.

Animal testing

For laboratories that experiment with animals, it is necessary to follow the rules related to the humanitarian use of animals, observing the procedures for installation and operation of breeding centers, bioteries and animal experimentation laboratories, of the National Council for The Control of Animal Experimentation (CONCEA), respecting the current legislation.

Risk Management

In addition to RDC 301/2019, this new RDC 512/21 also focuses on risk management. In this case, biosafety risk management and all activities with human, animal and environmental health agents, including waste management. Planning and actions for contingency plans are the new essence of this regulation, including periodic training appropriate to the defined levels.

What does RDC 512/21 say about internal audits?

According to RDC 512/21, quality control procedures should be implemented by the laboratory to monitor and guarantee the validity of the analyses. At the same time, internal audits of its activities should be carried out at least twelve months, keeping records of their findings and corrective actions arising.

Is your lab up to time with “Good Practices for Quality Control Labs”?

As you can follow, here are some of the “Good Practices for Quality Control Laboratories”, determined by RDC 512/21. If your lab needs the support of expert auditors to understand these and all other requirements detailed in this Collegiate BoardResolution, please know that Kivalita Consulting can assist you with this mission.

Our professionals are always attentive to the most rigorous regulatory requirements of the market, working in the development of quality management, laboratory projects and LTA,   validation of systems and definition of processes to avoid rework, risks and losses for laboratories and, in general, companies in the area of Life Science – especially pharmaceutical, food, cosmetic and chemical industries, among others.

Talk to us and learn more!

linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram