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    Production and Process Controls

    21 CFR 820.70 / ISO 13485 §7.5 requirements that production processes be planned, controlled, monitored, and validated where needed.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Covers documented procedures, environmental control, contamination control, equipment maintenance, personnel hygiene, and process changes. The clauses where 'process validation', 'in-process controls', and 'work instructions' all live.
    What the regulation says
    Production and Process Controls are mandated by regulations such as 21 CFR Part 820, specifically Subpart D for device design, Subpart E for purchasing and handling, Subpart F for identification and traceability, Subpart G for production and process controls, Subpart H for acceptance activities, and Subpart I for nonconforming product. These regulations require manufacturers to establish and maintain procedures to control production and processes to ensure that a device conforms to its specified requirements. The EU MDR (Regulation (EU) 2017/745) also emphasizes similar controls within its General Requirements for Safety and Performance (Annex I), particularly regarding manufacturing processes, sterility, and environmental control.

    What this means in practice

    Among the most frequently cited subparts in FDA Form 483 observations.

    Examples

    • A manufacturer of sterile surgical instruments must validate its sterilization process to ensure all product-contact surfaces are free of viable microorganisms, as required by ISO 11135.
    • A company producing implantable devices must maintain strict environmental controls in its cleanroom facility to prevent particulate contamination, aligning with ISO 14644 series.
    • Before implementing a new automated assembly machine, a MedTech company must perform process validation to confirm it consistently produces devices meeting specifications, as per 21 CFR 820.75.
    Common pitfalls
    • •Failing to validate all processes, even those not considered "special processes," can lead to non-conformities.
    • •Inadequate documentation of process changes, including justifications and verification activities, is a common deficiency.
    • •Not consistently monitoring and controlling environmental conditions, especially in cleanroom environments, can compromise product quality.
    • •Neglecting routine equipment calibration and maintenance can directly impact process stability and product conformity.
    • •Assuming personnel are adequately trained without documented evidence of their competency in specific production tasks is a critical oversight.

    Frequently asked questions

    A special process is one where the output cannot be fully verified by subsequent inspection and testing, and any deficiencies only become apparent after the device is in use. Such processes require validation to ensure they consistently produce a conforming product.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1FDA·1ISO·1
    1. 1
      21 CFR 820.70
      Verified
      eCFRecfr.gov
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.