Calibration inspection

Calibrating inspection, measuring, and test equipment (clause 4.11.2)... 

The standard requires the supplier to ensure that the environmental conditions are suitable for the calibration, inspections, measurements, and tests being carried out. 

Lacking SOPs on maintenance, calibration, inspection, or testing of data systems or part of systems... 

Pumps Relief, Reverse Rotation, Calibration, Inspection Frequency, Adequacy... 

Calibration inspection refers to comparison with a standard in accordance with certain statutory regulations by specially authorized personnel (Bureau of Standards). If the outcome of this regular inspection is positive, an operating permit for the next operation period (e.g. three years) is made visible for outsiders by means of a sticker or lead seal. If the outcome is negative, the instrument is withdrawn from operation. 

Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. 

System reliability, with routine calibration, inspection or checks to formal maintenance procedures results to be documented. 

Failure to assure [computer] equipment is routinely calibrated, inspected or checked according to a written program design to assure proper performance. [FDA Warning Letter, 2000]... 

Automatic, mechanical, or electronic processing equipment, or other types of equipment induding computers, used in the manufacture of APIs and intermediates should be routinely calibrated, inspected, and checked to ensure proper performance. Written records of those calibration checks and inspections should be maintained. 

It must be proven that a device will be suitable for the intended function in the preparation process by appropriate validation or qualification, see Sect. 34.15. Qualification and validation must be planned, described and documented. Responsibilities must be clear before the vaUdation process starts. Tests, calibrations, inspections and acceptance criteria must be laid down in a pre-approved qualification protocol. Raw and processed data, test results and ccmclusions must be documented. The result is the qualification or vahdation report, including test results and conclusirais. Qualification effort are highly dependent on the criticality of the equipment and the direct or indirect effect (impact) of the device on the quality of the preparation process and product. When purchasing a new device it is often possible to ask the supplier (by quality agreement) to qualify the equipment. This involves, usually, the Installation Qualification (IQ) and the Operational Qualification (OQ), sometimes also parts of the Performance qualification (PQ), although usually the user of the equipment has to take the responsibility for the execution of the PQ (see Sect. 34.10). 

Is there a procedure for regularly calibrating inspection, measuring and test equipment, and is it effectively applied ... 

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