Calibration schedule

Multiple analysis, blind sample and round robin tracking and variance reporting Automatic tolerance verification and limit checking Instrument calibration scheduling and tracking... 

During validation, the relationship between response and concentration is established. Checks also are made to ensure that the linearity of the method does not make too large a contribution to the measurement uncertainty (the uncertainty due to the calibration should contribute less than about 20% of the largest uncertainty component). The calibration schedule required during routine operation of the method is also established. It is wise to carry out sufficient checks on some or all of the following performance parameters, in order to establish that their values meet any specified limits. 

Calibration of critical instruments and system components must be controlled by a calibration schedule in order for call-off dates to be determined. The calibration periodicity should be determined by the process owner, its quality representative, and the maintenance engineer, taking into account the manufac-... 

Calibration records are normally stored in a dedicated calibration fde along with the calibration procedures and calibration schedule. The location of calibration records (e.g., the engineering maintenance filing system) should be recorded in the validation fde. 

Documents that cannot easily fit into the validation file or may be required on a day-to-day basis (e.g., supplier system manuals, calibration schedule, and records) may be filed elsewhere, and these should be identified on the document schedule stating where they are located and identifying who is responsible for them. All documentation provided by the supplier must be suitably marked to easily identify its location in the validation file. It is acceptable to have the system development records archived by the supplier. If the pharmaceutical manufacturer requires the supplier to store and maintain the documents there needs to be a formal agreement on the retention period. 

Calibration schedule Chain of custody Controlled documents Methods documentation Procedure Protocol... 

A calibration schedule details the calibration of balances, volumetric glassware, automatic pipettes, thermometers, pH and conductivity meters, wavelength and photometric scales etc. The schedule consists of periodic external checks, employing a suitably accredited calibration service, supported by more regular in-house performance checks. 

Instrumentation will include field instruments used in the manufacturing process and other instruments assoeiated with special tasks, such as that of monitoring laboratory or computer room environmental eonditions. The accessibility of instruments must be such as to permit their eleaning and maintenanee. Siting is also important, and instruments should be installed as close to the point of measurement as possible. The placement of flowmeters in piping dead-legs should be avoided. Careful consideration should also be given to the appropriate position of other instruments sueh as thermometers and thermocouples so that they, too, can fulfill their measurement and eontrol functions. Construction materials that come into direct contact with the pharmaceutical or healthcare production process stream must not contaminate or affect the manufactured product in any way. Instrument lubricants and coolants must not come into contact with in-process product or equipment. The reliability of instruments should also be considered for instance, a pressure transmitter that uses atmospheric pressure as its reference may suffer from poor reliability. A draft calibration schedule may also be prepared. 

Maintenance spares, special handling practices and tools, cleaning, media backups and restoration, service contracts, service instructions, calibration schedules... 

Instrumentation must be accessible to facilitate operations and be covered by maintenance and calibration schedules. Loop checks should be made for instrumentation. Inputs and outputs must be checked to provide strong assurance of accuracy. 

All documentation furnished by the supplier should be available. User manuals, as-built drawings, instrument calibration records, and procedures for operation and maintenance (including calibration schedules) of the system should all be checked to verify that they are suitable. Supplier documentation should be reviewed for accuracy in its specifications of the various versions of software used and approved as fit for purpose. It is recommended that checks are made to verify that contingency plans, SOPs, and any Service Level Agreements (SLAs) are also in place. Any specific competencies supposed to be acquired before the IQ/OQ/PQ through training should also have been achieved — these records should be checked. 

Engineering Management Calibration Scheduling Maintenance Scheduling Work Orders... 

In the first year, the analyst will wish to double-check the process fairly often to assure himself/herself that the new instrument is doing its job. One valuable result of this close monitoring is the ability to plan a maintenance and calibration schedule. 

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