Provides for Good Manufacturing Practices for Active Pharmaceutical Ingredients.
This Resolution establishes the procedures and practices that the manufacturer must apply to ensure that the facilities, methods, processes, systems and controls used for the manufacture of active pharmaceutical ingredients are adequate, in order to guarantee quality and allow their use in the preparation of products pharmacists.
This Resolution applies to companies that carry out the operations involved in the manufacture of drugs, including experimental drugs.
RDC 654 of the National Health Surveillance Agency (ANVISA) brings several advantages to the Pharmaceutical Input Manufacturing sector:
- Greater safety for patients: RDC 654 establishes specific technical requirements that must be followed by companies to guarantee the safety, efficacy and quality of supplies. This helps to reduce the risk of contamination and other quality issues that could affect patient health.
- Greater safety for patients: RDC 654 establishes specific technical requirements that must be followed by companies to guarantee the safety, efficacy and quality of sterile drugs. This helps to reduce the risk of contamination and other quality issues that could affect patient health.
- Greater safety for patients: RDC 654 establishes specific technical requirements that must be followed by companies to guarantee the safety, efficacy and quality of sterile drugs. This helps to reduce the risk of contamination and other quality issues that could affect patient health.
Meeting this quality objective is the responsibility of the company’s top management and requires the participation and commitment of the team at all levels of the organization, as well as its suppliers and distributors.
To reliably achieve this quality objective, there must be a comprehensive and correctly implemented Pharmaceutical Quality System, incorporating Good Manufacturing Practices and Quality Risk Management.
The Pharmaceutical Quality System must be fully documented and have its effectiveness monitored, through management review, in order to promote continuous quality improvement.