10/30/2019
The plenary board of the Brazilian health surveillance agency ANVISA issued on October 7 a regulation laying down the regulatory framework on good manufacturing practices (GMP) for drugs in Brazil (resolution No. 301 of August 21, 2019). Fourteen new normative rulings were also issued on August 21 introducing supplementary rules.
Even though already in force, the regulation sets different deadlines for compliance with the requirements it imposes. For example, companies will have 24 months – from the regulation effective date – to have at least 30% of its entire product portfolio (both commercial and experimental) in full compliance with all requirements imposed by the regulation.
The new regulation improves Brazil’s good manufacturing practices for drugs and revokes the previous regulation (RDC No. 17/2010) which was until now considered the cornerstone of GMP for the pharmaceutical industry in Brazil. It also revokes a number of other resolutions, including those dealing with GMP for phytotherapeutic drugs, radiopharmaceuticals, blood products, etc.
The new GMP rules were based on the GMP under the Pharmaceutical Inspection Co-operation Scheme, or PIC, which has already been adopted by 47 countries. Now, in Brazil, the PIC GMPs are the minimum requirements to be met when it comes to drug manufacturing.
One of the main changes brought by the new GMP regulation is that it attaches greater importance to quality control rules, which is a win for consumers and patients, who will benefit from safer and more efficient drugs.
When dealing with the Pharmaceutical Quality System, the new regulation prescribes that those who are authorized to manufacture drugs must do so in a way that ensures that they are fit to the intended use and comply with all requirements of the registration or clinical trial authorization, as appropriate, and do not place patients at risk due to inadequate safety, quality or efficacy. It also stipulates that attaining quality is the responsibility of the company’s senior management and requires participation and commitment by staff at all levels of the organization as well as by the company’s suppliers and distributors.
Moreover, it states that it is up to the company’s senior management to ensure that the Pharmaceutical Quality System be adequately resourced with competent personnel, and suitable and sufficient financing, premises, equipment and facilities, thus facilitating continuing improvement of its activities.
When it comes to Pharmaceutical Quality Management System, good documentation is a key aspect that must be at all times observed.
The new GMP regulation determines that all those involved in the drug manufacturing chain are responsible for the quality of the end product. This is why special attention must be taken when activities are outsourced.
In case of outsourced activities, the new GMP regulation determines that there must be a written contract which clearly establishes the roles and responsibilities of each party. In any such event, the contract giver is to be ultimately responsible to ensure processes are in place to assure the control of outsourced activities, including by adding to the contract a provision allowing for the audit of outsourced activities conducted by both the contract acceptor or any subcontractors.
Records on all outsourced activities (analytical and distribution records, and reference samples) must be kept and be readily available to the contract giver.
Clearly, the entire drug manufacturing chain is to comply with the new GMP regulation within the deadlines set by the new rule and provide training to the professionals that will be engaged in the production process, quality, quality control, packaging and all activities involved in the manufacturing and marketing of drugs.
