Status calibration

A note in clause 4.11.2 also accepts a serial number traceable to the device calibration record as meeting the intent of the requirement on calibration status indicator. 

Knowing that the measurements made using the instrument are accurate so that you can rely on the results - a valid calibration status label will fulfill this purpose. 

The standard requires the supplier to identify inspection, measuring, and test equipment with a suitable indicator or approved identification record to show the calibration status. 

Provide labels for fixing to devices in order to denote their calibration status. 

Do fix labels to all devices that have been designed for inspection purposes and indicate their calibration status. 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

Calibrated equipment is appropriately labelled or otherwise identified to ensure that it is not confused with uncalibrated equipment and to ensure that its calibration status is... 

Measuring equipment shall be calibrated or verified at specified intervals or prior to use and adjusted as necessary. The calibration status of each piece of equipment shall be identified and records of the calibration and verification results shall be maintained. When a piece of equipment is found not to conform to requirements, the previous measuring results shall be corrected. 

Is there a procedure of labeling that identifies the calibration status of... 

Calibration of dissolution equipment. It is very important to ensure that the calibration of the dissolution equipment is kept up to date. The expiry date of the calibration status should be checked each time that dissolution testing is performed. 

All inspection, measuring, and test equipment is capable of the accuracy and precision necessary. Prior to use, all inspection, measuring, and test equipment is identified, calibrated, and adjusted as required. Calibration and adjustments are made are against standards of certified equipment, traceable to the National Institute of Standards and Technology (NIST, where no such standard exists, the basis used for calibration is documented). Inspection, measuring, and test equipment is identified with a suitable indicator or approved identification record to show the calibration status. 

Uniquely identified and, where practical, marked with calibration status... 

Equipment list and qualification and calibration status Process flow diagram Process variable tolerances... 

The current calibration status of critical equipment/instmmentation should be known and verifiable. 

There should be a means of readily determining the calibration status of instrumentation. Calibration records should be maintained. 

When the equipment, instruments and other devices have not been used for a certain period of time, their function and calibration status should be verified and shown to be satisfactory before use. 

System calibration refers to the periodic operational qualification of the HPLC, typically every 6 to 12 months in most regulated laboratories. This calibration procedure is usually coordinated with an annual preventative maintenance (PM) program and is performed immediately after PM. A calibration sticker is placed on the instrument to indicate its calibration status and readiness for GMP work. The reader is referred to the principles and strategies behind HPLC calibration criteria published elsewhere.8 A summary of the calibration procedures and acceptance criteria, including additional procedures recommended for initial operational qualification, is listed in Table 9.3. 

All process and facility instruments are classified as to their calibration status into one of the three following categories ... 

In practice, calibration is never perfect and assumptions often have to be used, after appropriate peer review. This is illustrated by Figiue 4.2, which summarises the calibration status of the three North American case studies, with two from the UK for comparison. 

I I Good data from surveys or testing I I Estimates or general assumptions Figure 4.2 Calibration status of case studies. 

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