21 CFR 211.182 - Equipment Cleaning and Use Log

What it says

A written record of major equipment cleaning, maintenance and use must be included in individual equipment logs or in the batch production record, showing the date, time, product and lot number of each batch processed, and the identity of the person performing the cleaning and maintenance.

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

What it means in practice

• Equipment logs create the traceability link between a specific piece of equipment and every batch it touched, which is essential evidence for any subsequent investigation into contamination, cross-contamination or equipment-related deviation.
• The log must capture cleaning and maintenance events with the same rigor as production use, since a gap in cleaning documentation is functionally the same traceability failure as a gap in production use documentation.
• This requirement underlies the ability to answer, definitively, which specific batches used a given piece of equipment during any defined time period, a question that becomes critical during an investigation or recall.

What FDA inspectors look for

• Whether equipment logs are complete, contemporaneous and free of gaps, particularly around cleaning events between different products or batches.
• Whether the log can be used to accurately reconstruct which specific batches shared use of a given piece of equipment within a relevant timeframe.
• Whether missing usage logbook entries are treated as a data integrity gap requiring investigation, rather than a minor administrative oversight.

Related regulations