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.