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)
Uncalibrated equipment used in production or inspection is a common 483 citation.
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