21 CFR 211.100(b) - Production and Process Control Deviations

What it says

Any deviation from a written production and process control procedure must be recorded and justified. Written production and process control procedures must be followed and documented at the time of performance, and any departure from them must be justified in writing.

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

What it means in practice

• A batch record showing a step performed differently than the approved procedure describes is not automatically a violation, but an undocumented or unjustified departure is.
• Quality unit review of batch records must specifically look for deviations from the approved procedure, not just confirm that a batch record was completed and signed.
• This provision is the regulatory anchor for deviation management and investigation systems, since it requires that departures be captured and justified rather than silently absorbed into routine practice.

What FDA inspectors look for

• Whether deviations from written procedures found during batch record review were actually documented and investigated, rather than corrected informally without a record.
• Whether the justification given for a deviation is scientifically sound and specific to the batch, rather than a generic or boilerplate explanation reused across multiple deviations.
• Whether repeated deviations from the same step of a procedure were evaluated for a systemic root cause rather than each being treated as an isolated event.

Related regulations