Calibration, Verification of Performance and Qualification of Equipment, Instruments and other devices in Quality Control. Each item of equipment, instrument or other device used for testing, verification and/or calibration should, when practicable, be uniquely identified.
All equipment, instruments and other devices (e.g. volumetric glassware and automatic dispensers) requiring calibration should be labelled, coded or otherwise identified to indicate the status of calibration and the date when re-calibration is due.
Laboratory equipment should undergo design qualification, installation qualification, operation qualification and performance qualification (for definitions of these terms see the Glossary) (11). Depending on the function and operation of the instrument, the design qualification of a commercially available standard instrument may be omitted as the installation qualification, operational qualification and performance qualification may be considered to be a sufficient indicator of its suitable design.
As applicable, the performance of equipment should be verified at appropriate intervals according to a plan established by the laboratory.
Measuring equipment should be regularly calibrated according to a plan established by the laboratory (11).
Specific procedures should be established for each type of measuring equipment, taking into account the type of equipment, the extent of use and supplier’s recommendations. For example:
— pH meters are verified with standard certified buffer solutions before use;
— balances are to be checked daily using internal calibration and regularly using suitable test weights, and requalification should be performed annually using certified reference weights.
Only authorized personnel should operate equipment, instruments and devices. Up-to-date SOPs on the use, maintenance, verification, qualification and calibration of equipment, instruments and devices (including any relevant manuals provided by the manufacturer) should be readily available for use by the appropriate laboratory personnel together with a schedule of the dates on which verification and/or calibration is due.
Records should be kept of each item of equipment, instrument or other device used to perform testing, verification and/or calibration. The records should include at least the following:
- the identity of the equipment, instrument or other device;
- the manufacturer’s name and the equipment model, serial number or other unique identification;
- the qualification, verification and/or calibration required;
- the current location, where appropriate;
- the equipment manufacturer’s instructions, if available, or an indication of their location;
- the dates, results and copies of reports, verifications and certificates of all calibrations, adjustments, acceptance criteria and the due date of the next qualification, verification and/or calibration;
- the maintenance carried out to date and the maintenance plan; and
- a history of any damage, malfunction, modification or repair.
It is also recommended that records should be kept and additional observations made of the time for which the equipment, instruments or devices were used.
- Procedures should include instructions for the safe handling, transport and storage of measuring equipment. On reinstallation, requalification of the equipment is required to ensure that it functions properly.
- Maintenance procedures should be established, e.g. regular servicing should be performed by a team of maintenance specialists, whether internal or external, followed by verification of performance.
- Equipment, instruments and other devices, either subjected to overloading or mishandling, giving suspect results, shown to be defective or outside specified limits, should be taken out of service and clearly labelled or marked. Wherever possible they should not be used until they have been repaired and requalified.
- When the equipment, instruments and other devices are outside the direct control of the laboratory for a certain period or have undergone major repair, the laboratory should requalify the equipment to ensure its suitability for use.
Note: For further guidance on calibration, verification of performance and qualification of equipment refer to:
- Procedures for verifying and calibrating refractometers, thermometers used in determinations of melting temperatures and potentiometers for pH determinations and methods for verifying the reliability of scales for ultraviolet and infrared spectrophotometers and spectro-fluorometers in The International Pharmacopoeia (19);
- Specific guidelines for qualification of equipment elaborated by the European Network of Official Medicines Control Laboratories (OMCL) (20); and
- General chapter of the US Pharmacopeia on Analytical instrument qualification (21).
Traceability
The result of an analysis should be traceable, when appropriate, ultimately to a primary reference substance.
All calibrations or qualification of instruments should be traceable to certified reference materials and to SI units (metrological traceability).