The Brazilian Health Regulatory Agency (ANVISA) provides detailed guidelines for the qualification of pharmaceutical inputs’ suppliers – Normative Instruction (IN) n. 62/2020 specifies the guidelines for the qualification of suppliers of pharmaceutical inputs announced in Resolution n. 204/2006 of the Board of Directors (RDC)
Normative Instruction n. 62/2020 establishes that the selection, qualification, approval, and maintenance of suppliers of pharmaceutical inputs – together with their purchase and acceptance processes – must be documented as part of the quality management system. Also, the level of surveillance must be proportional to the risks presented by the inputs, considering their origin, manufacturing process, the complexity of the supply chain, and the purpose of the drug component.
According to the Normative Instruction, quality requirements for pharmaceutical inputs must be agreed with suppliers. Production, testing, and control aspects – including handling, labeling, packaging and distribution requirements, complaints, recall, and disapproval procedures – must be documented as part of a formal quality or specification agreement. The new Instruction will enter into force on August 3, 2020, and companies will have deadlines to adapt and comply with these regulations. Non-fractionated batches of pharmaceutical inputs distributed exclusively for the pharmaceutical industry are not affected by this IN.
