According to the Code of Federal Regulations (21 CFR 211.68 Automatic, mechanical and electronic equipment), equipment used in the manufacture, processing, packing, and hold of a drug product must be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections must be maintained.
A company recently received the following observation:
…. Routine calibration and checking of electronic equipment is not performed according to a written program designed to assure proper performance.
Specifically,
a. Balances used in production areas undergo a … weight verification that does not correspond with the actual date the balance is used. This impacts Balance ID …, …, and …. For example:
- Balance … underwent a … weight verification on … , but was used to perform in-process weight testing of …, lot … on …
- Floor Scale … (incorrectly identified as … in batch record) underwent a … weight verification on …, but was used to … materials for …, lot … on ….
- Floor Scale … (incorrectly identified as … in batch record) underwent a … weight verification on …, but was used to … materials for … and …, lot … on …
Additionally, the Production Manager described that floor scale … can be moved as needed, but this is not documented in the logbook; and we observed this scale to be unplugged.
b. The metal detector, asset …, used to check tablets for contamination with ferrous, non-ferrous, and stainless-steel particles, does not undergo any documented verification of suitable performance prior to use.
The failure to perform calibration or checking of equipment according to a written program is a repeat observation from the previous inspection.
For additional information on equipment calibration requirements, refer to FDA presentation: Facilities and Equipment: cGMP Requirements, guidance document: Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients, FDA’s Questions and Answers on GMP Manufacturing Practice Requirements/ Laboratory Controls and FDA’s Guide to Inspections of Medical Device Manufacturer’s – Inspection, measuring and test equipment.
To view more observations pertaining to routinely calibrated equipment, refer to the following GMP Trends® Issues: 1125, 1123, 1120 and 1118.
For more observations pertaining to manufacturing controls, see our new Issue 1129 available today. It also has observations pertaining to quality systems, sterile manufacturer’s and medical devices.
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