Process validation per GHTF/SG3 covers Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to demonstrate process capability for specifications that cannot be fully verified by subsequent inspection or test. ISO 13485 clause 7.5.6, now part of FDA's QMSR, requires validation of any process whose output cannot be fully verified, such as sterilization, sealing, molding and welding. GHTF SG3/N99-10 remains the main guidance. Validated processes must be monitored and revalidated after changes, deviations or trends, and software used in production needs its own validation.

Why it matters

Sterilization, injection molding, and software-controlled assembly are common validated processes.

Common pitfalls

•Confusing process validation with design validation, which focuses on validating the device design meets user needs and intended uses.
•Failing to revalidate a process after significant changes to equipment, materials, or methods.
•Not adequately documenting all validation activities, including protocols, results, and deviations.
•Overlooking the need to validate supporting processes, such as cleaning or software used in manufacturing.
•Treating process validation as a one-time event rather than an ongoing activity through process monitoring and control.

Sources

GHTF SG3 Process Validation Guidance · GHTF/IMDRF
ISO 13485 Standard Page · ISO
FDA - Device Manufacturing · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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