Production & Process Controls
Production and process controls ensure that devices are manufactured consistently to specification. They include process validation, manufacturing procedures, equipment maintenance, and environmental monitoring.
Regulatory basis — §§ 820.70–820.86
21 CFR §§ 820.70–820.86 (QMSR) cover production and process controls. Key sections:
| Section | Requirement |
|---|---|
| § 820.70(a) | General — establish and maintain production and process control procedures |
| § 820.70(b) | Environmental control (cleanrooms, contamination control) |
| § 820.70(c) | Personnel — health, cleanliness, personal practices |
| § 820.70(d) | Contamination control |
| § 820.70(e) | Buildings — adequate space, design, construction |
| § 820.70(f) | Equipment — maintenance and calibration |
| § 820.70(g) | Manufacturing materials — controlled, identified, and tested |
| § 820.70(h) | Automated processes — software validation |
| § 820.75 | Process validation |
| § 820.86 | Acceptance status — identification throughout manufacturing |
Process validation — § 820.75
Process validation is required when the output of a process cannot be fully verified by subsequent inspection and testing. Typical validated processes in device manufacturing:
| Process | Why validation is required |
|---|---|
| Sterilisation (EO, radiation, steam) | Cannot directly inspect sterility of every unit |
| Welding (thermal or ultrasonic) | Internal bond strength not visually inspectable |
| Clean room operations | Contamination not always detectable |
| Software-controlled manufacturing | Automated process outcomes |
| Lyophilisation (freeze-drying) | Residual moisture not fully measurable post-process |
Validation protocol requirements
Process validation protocols must address:
- IQ (Installation Qualification) — equipment installed and configured correctly
- OQ (Operational Qualification) — equipment operates within specified parameters
- PQ (Performance Qualification) — process consistently produces product meeting specifications under actual production conditions
Equipment calibration and maintenance — § 820.70(f)
All inspection, measuring, and test equipment must be:
- Identified with calibration status
- Calibrated at defined intervals against recognised standards
- Maintained with calibration records (equipment ID, calibration date, next due date, results)
Use of uncalibrated inspection or measuring equipment in production decisions or acceptance testing is a common and serious 483 citation that can invalidate inspection and acceptance records.
Environmental controls — § 820.70(b)
Where necessary to prevent contamination of device or product:
- Establish and maintain procedures for environmental monitoring (particle counts, temperature, humidity, viable bioburden)
- Define environmental specifications for each manufacturing area (cleanroom class, temperature range, etc.)
- Document environmental monitoring results as part of the DHR
Official resources
Process validation must be revalidated when significant changes are made to the process, equipment, manufacturing location, or materials that could affect process capability or product quality. Change control procedures must trigger revalidation evaluation.