Chapter 21: Instrument Control and Record Keeping

All laboratory instrumentation must be maintained to ensure proper functioning. Instrumentation is numbered so it can be easily identified during testing. If an instrument is used in a good manufacturing practices (GMP) environment, it will have the appropriate qualification and calibration performed. In a research and development environment, instrumentation does not require routine calibration, although a minimum standard for verification should be established to ensure data accuracy.

As an instrument is acquired in a GMP environment, it should be assigned a unique identification number. Some companies will use an abbreviation of the instrument with a set of numbers for the unique identification (for example, balances will be numbered as Bal 22, Bal 23, Bal 24). The associated documentation links this unique identification to the instrument type, model, and serial number. Documentation includes when an instrument was put into service and when it was retired.

Instrumentation can be classified into one of three categories (minor, intermediate, or major). Appropriate categorization of instruments depends on the intended use of the end user. Minor instruments, such as stirring plates, water baths, and sonicators, that do not perform any measurements do not require any calibration or qualification. Intermediate instruments such as thermometers and timers have little or no configurability, and typically perform a single task. Qualification for intermediate instruments is typically limited to installation qualification (IQ) and operational qualification (OQ), with the OQ consisting of calibration. Major instruments are those that are multifunctional and configured with multiple components, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), infrared (IR), and ultraviolet (UV)-Vis spectrophotometers. These instruments require full qualification (IQ, OQ, and performance qualification [PQ]).

Based on the instrument category, IQ, OQ, and PQ may be required when a new instrument is introduced into the laboratory, a critical part is replaced, or instrumentation is moved from one location to another. A protocol defines the purpose or objective, test procedures to be followed, parameters to be evaluated, and the criteria to demonstrate acceptability. This may be done through the change control process.

The IQ is conducted to ensure that the instrument and software, if applicable, were installed in the proper environment and manner as intended by the manufacturer. The OQ is conducted to ensure that the instrument and software, if applicable, operate as designed and generate accurate data. The PQ is conducted to ensure that the instrument and software, if applicable, meet the end user specific requirements and function as intended in the production environment. A report summarizes the test results for the qualifications and any deviations. Upon completion of the qualification, the instrument can be put into service.

For instruments in the GMP environment, routine maintenance and calibrations are required. The maintenance and calibration schedules for laboratory instrumentation can be established based on severity of environment, severity of use, frequency of use, durability of the instrument, accuracy of measurement required, precision of measurement required, and history of maintenance and calibration. Each type of instrumentation should have a procedure that specifies its operation, maintenance, and calibration. The procedure must specify what activity should be conducted, what the acceptance criterion is, and the frequency. An instrument logbook may be used to track the usage, repair, and calibration of the instrument. All maintenance and calibration information, which includes reagents or standards used, must be documented. When an instrument requires repair or calibration, it should be flagged as out of service in some manner, such as with an “Out of Service” sticker. If an instrument fails the calibration, an impact assessment must be performed. During the impact assessment, all data generated since the last successful calibration must be evaluated. Upon completion of the repair or calibration, the out-of-service indicator is removed and the instrument is placed back into service. If the instrument was being calibrated, a new calibration sticker, which designates the next calibration due date, is applied.