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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 this means in practice

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

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    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

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