Production & Process Controls

RDC 752/2022 requires that production processes are carried out under controlled conditions. Key requirements:

• Documented work instructions for all critical manufacturing operations;
• In-process inspection and testing at appropriate stages;
• Equipment calibration and maintenance — all measuring and monitoring equipment must be calibrated;
• Environmental monitoring — clean rooms, temperature/humidity controls as required;
• Traceability — ability to trace each device back to raw materials and production records (lot/batch);
• Process validation — for processes whose output cannot be fully verified by inspection (e.g., sterilisation, welding, adhesive bonding); and
• Labelling controls — prevention of mix-ups and correct application of labelling.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

Personnel involved in production and quality control must receive documented training appropriate to their role. Training records must be maintained and made available during inspections. Personnel must demonstrate competence before performing critical manufacturing or quality control tasks.