Execute a cGMP batch-record step

Practice the 21 CFR 211.188 batch-record order. Line clearance and the correct record revision are verified first, and the next step is not started until the current step is signed contemporaneously and within specification.

1. Verify line clearance.
2. Verify the correct batch-record revision.
3. Weigh or measure against the issued bill of materials.
4. Perform the step exactly as written; do not skip or combine steps.
5. Record the actual value, time, and operator at the time of performance.
6. Obtain the required in-process check or second-person verification.
7. Do not proceed if a result is out of specification; notify QA.