21 CFR 820.70 - Production and Process Controls

What it says

Manufacturing processes that could cause a device to deviate from its specifications must be developed, conducted, controlled and monitored using documented instructions, procedures or specifications, with process control methods applied wherever their absence could adversely affect device quality.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision is the device quality system counterpart to in-process control requirements for drugs, establishing that process control is expected wherever it materially affects whether the finished device meets specification.
• Environmental controls, equipment maintenance and cleanliness requirements referenced within this provision mean process control extends beyond the manufacturing steps themselves to the conditions surrounding them.
• Where a process's output cannot be fully verified by inspecting the finished device, such as a sealing or bonding process, this provision connects directly to the process validation expectations in 21 CFR 820.75.

What FDA inspectors look for

• Whether documented process control procedures actually exist for manufacturing steps that could affect device quality, and whether they are being followed in practice.
• Whether environmental conditions, such as cleanliness or temperature, are controlled and monitored where the process specification requires it.
• Whether processes whose results cannot be fully verified afterward are being controlled through validated parameters rather than relying solely on downstream inspection.

Related regulations