Quality & Risk
Production and Process Controls
In one line
21 CFR 820.70 / ISO 13485 §7.5 requirements that production processes be planned, controlled, monitored, and validated where needed.
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.
Under the QMSR, these requirements sit in ISO 13485 clauses 7.5 and 6.4, covering control of production, cleanliness, installation, servicing, process validation, identification, traceability and preservation of product. Processes whose output cannot be fully verified by later inspection, such as sterilization, sealing or molding, must be validated. Monitoring data such as statistical process control is often reviewed during inspections.
Why it matters
Among the most frequently cited subparts in FDA Form 483 observations.
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.
Sources
- 21 CFR 820.70 · eCFR
- FDA - Quality Systems · FDA
- ISO 13485 Standard Page · ISO