21 CFR 211: what it asks of a calibration register
21 CFR 211.68 requires automatic, mechanical or electronic equipment used in manufacture, processing, packing or holding to be routinely calibrated, inspected or checked according to a written program. The calibration of laboratory instruments in 211.160(b)(4) is named here and not stated: the held text covers the general requirement of 211.160 only.
Named, not quoted: 21 CFR 211.160(b)(4), the paragraph on the calibration of laboratory instruments. The held text of Section 211.160 is its general requirement, set out below.
Findings that cite it
| Finding | Clause |
|---|---|
| 1. Overdue: the due date worked out is earlier than the as-at date | 21 CFR 211.68 |
| 8. Calibrated in house with no procedure named | 21 CFR 211.68 |
21 CFR 211: every clause cited
2 of the 76 heldThe requirement text is our statement of each clause, read against the copy we hold and cited to it; it is not the standard verbatim.
21 CFR 211.68Automatic, Mechanical, and Electronic EquipmentAutomatic, mechanical, or electronic equipment used for manufacture, processing, packing, or holding shall be routinely calibrated, inspected, or checked according to a written program.
21 CFR 211.160Laboratory controls: general requirementsLaboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures.