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  • Writer's pictureInovatie Serviços em Saúde

What is important about the new regulatory framework for good manufacturing practices?

In March, RDC 301/19 and 14 Normative Instructions that improve the regulatory framework for Good Manufacturing Practices (GMP) of medicines came fully into force. What is important to know?

1. Establishes the general rules of GMP and 14 standards for specific topics to complement:

The new rules of RDC 301 enable Brazil to join the Pharmaceutical Inspection Co-operation Scheme (PIC / S) and open the way for the sharing of information and the mutual recognition of international GMP inspections between member countries.

2. Main Challenges of the New GMP Regulatory Framework:

a) The provisions regarding GMP must be observed throughout the “life cycle” of the products, starting at the development stage and incorporating the concept of Quality by Design.

b) On-site audits to qualify suppliers become mandatory.

c) Quality agreements for productive and non-productive third parties must be entered into.

d) Periodic Management Review on the Quality Management System with the involvement of the company's top management must be formalized in order to identify opportunities for continuous improvement of products, processes and the system itself.

e) Automation of packaging and ampoule integrity testing equipment becomes mandatory.

f) Robust deviation investigations should be carried out in order to avoid justification for human error, as well as analysis of the effectiveness of complex changes.

g) Risk management for risk mitigation and area share passes to be necessary.

h) Qualification and validation procedures have a multidisciplinary character, involving other technical-scientific areas such as, for example, the need for toxicological calculations to validate the cleaning of medicines, as well as statistics for the process.

i) In the validation of the manufacturing equipment, the Factory Acceptance Test (FAT) and the Field Acceptance Test (SAT) will be required

j) Specific qualification of transport will be required but will still be subject to complementary regulations.

3. Advantages of the New Regulatory Framework:

With the update of the GMP regulatory framework and the matching of requirements to those of PIC / s, it is believed that Brazil will become a more attractive and competitive market, expanding opportunities in the pharmaceutical market.

This fact will facilitate the understanding of Brazilian rules by international manufacturers, as well as creates the expectation of streamlining the GMP certification process for these companies.

As the new rules bring Brazil closer to international standards of reference in GMP, they enable the expansion of drug exports to the largest pharmaceutical markets in the world.

PIC / s member regulatory authorities are Argentina, Australia, Austria, South Africa, Belgium, Canada, Croatia, Cyprus, Spain, Slovakia, Denmark, Czech Republic, France, Slovenia, Germany, Finland, Estonia, Greece, Iceland, Hong Kong, Taiwan, Hungary, Ireland, Indonesia, Italy, Iran, Israel, Japan, South Korea, Latvia, Lithuania, Liechtenstein, Malta, Malaysia, Mexico, Netherlands, Norway, Poland, New Zealand, United Kingdom, Portugal, Romania, Switzerland, Sweden, Turkey, Ukraine and the United States.

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