21 CFR 117.175 - Records Required for Subpart C

What it says

Records required by Subpart C must be kept as original records, true copies or electronic records, must contain the actual values and observations obtained during monitoring, must be accurate, indelible and legible, created concurrently with the activity documented, and as detailed as necessary to provide history of work performed. Records must include the name and location of the plant, the date and time of the activity, the signature or initials of the person performing the activity, and the identity of the product and lot code where appropriate.

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

What it means in practice

• Records are the proof that preventive controls were carried out, so they have to be made at the time of the activity.
• Recording values that were not observed, or filling in records in advance, defeats their purpose.
• A record should let someone reconstruct what happened, with date, time, product, and who did it.

What FDA inspectors look for

• Whether records are complete, legible and created at the time of the activity.
• Whether records contain actual values and not just a check mark.
• Whether records are signed or initialed and reviewed.

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