On August 20, 2019, ANVISA approved a new regulatory framework, which concerns good drug manufacturing practices in Brazil. This regulatory standard replaces RDC 17/10 and details the Pharmaceutical Inspection Cooperation Scheme, PIC/s, as a minimum requirement to be followed in the production of medicines, to ensure the best quality of the products handled.
Details of the New GMP Regulatory Framework
The approval allows the population to have access to much safer medicines and improves the Brazilian regulatory framework, which will comply with international standards, which are reference. In addition to the Resolution of the Collegiate Board, another 14 Normative Instructions on Good Manufacturing Practices underwent updates.
And what does it mean? The new guidelines make it possible for Brazil to expand drug exports to major pharmaceutical markets around the world. This brings another important factor for our pharmaceutical industry: competitiveness with the giants of the sector. This factor makes it possible to join the Pharmaceutical Inspection Co-operation Scheme (PIC/s).
It is important to say that the preparation of this regulation was based on the PIC/s GMP guide, as it is understood that it is compatible with ANVISA's actions, due to the convergence of public policies and business strategies for the pharmaceutical industry.
This guide is an international reference and the most used worldwide. By complying with it, the update process makes GMP regulation of medicines equivalent to the 47 countries that also adopted the guidelines.
Need to update
Before this new regulatory framework was approved, in Brazil, the one based on the 2003 World Health Organization (WHO) guide was in force. In other words, even with advances around the world, the changes were not followed here. So it was necessary to adapt and adhere to this modernization of the regulation of GMP for medicines.
More quality and safety for everyone
The determinations and guidelines of Good Manufacturing Practices are the main regulators of the quality of medicines. This standard ensures that when they reach the final consumer, they comply with the necessary standard, reconciling safety and effectiveness.
And for this to happen, just performing some isolated tests is not enough. All products must be manufactured under the full range of conditions and practices required by regulations.
The importance of good drug production
With the updating of normative instructions and expansion of the drug market abroad, it is extremely important that all of them are produced safely and that they guarantee effectiveness for the population.
In this regard, clean rooms play a key role. They ensure that all products handled maintain the required quality.
Some of the controls carried out in these places that contribute to the integrity of medicines are: parameters of temperature, air pressure and humidity, air filtration, in addition to the composition of controlled environments with equipment specially developed to avoid external contamination.
Clean area projects are developed considering every detail and the needs employed at the site, according to the activities to be carried out. Walls, ceilings, the corners of the room, everything should be as clean as possible.
The floors are even an important part of the process. They are easy to clean and maintain, with light colors that allow you to see any type of dirt. All factors contribute to the highest levels of purity.
See some of the equipment present in a clean room, ideal for a project in the pharmaceutical industry:
- Antechamber with Air Shower System;
- Pass Through Active with individual filtration system;
- Filter lining with Wi-Fi control.
The products mentioned above (and the other components of a clean room), combined with the necessary preparation of the professionals who will work on site, will guarantee the best conditions for the production of medicines.
The main advances provided by the standard
According to data from ANVISA, nowadays, 85% of the generic drugs that are consumed in Brazil are produced in the national territory, and almost 9% come from India.
In addition to becoming more attractive in the market, with this new update of the GMP regulatory framework, in balance with the requirements of the PIC/s, it will be possible for Brazilian pharmaceutical industries to recover this 9%.
Benefits of the GMP Regulatory Framework
The importance of the pharmaceutical industry for our country is indisputable. And these normative instructions approved by ANVISA leave Brazil in a more equal position, not only for access to the pharmaceutical market, but also for its expansion.
The population is also a great beneficiary: it has more access to quality medicines.
Another fundamental impact of this update on the GMP regulation is that drug manufacturers located here in the country now have access to markets that they did not have before.
International reference regulations
In addition to playing a very important role in the coordination and harmonization of Good Manufacturing Practices activities at the national level, ANVISA is also positioned as an international reference in this matter. This means that regardless of who the drug manufacturer destined for the Brazilian market is and from what part of the world it is, it must comply with GMP standards.
It is also essential to emphasize the role that ANVISA plays in the elaboration of guidelines and development of procedures, to ensure that the interpretation of normative requirements is in accordance with the National Health Surveillance System (SNVS), as well as all technical issues that are in connection with inspection activities.
The PIC/s
O Pharmaceutical Inspection Co-operation Scheme, currently, has 57 members from 47 countries. Collaboration is not limited to medicines intended for human use, but also to veterinary use.
This is why some countries have more than one authority/member. Each nation, even if it has more than one affiliated institution, has the right to one vote and all decisions are taken by consensus.
As mentioned, with the approval of this regulatory framework, the Brazilian pharmaceutical industry will be increasingly inserted in the world scenario. And with a more attractive and competitive market, it is essential that medicines are handled and produced in a way that ensures quality and safety for the consumer.
Therefore, having a good clean rooms project is imperative.
Asmontec provides complete solutions in all phases of the process: project development, manufacturing, installation and maintenance. Talk to one of our representatives and request your quote.