Calibration Presentation.pptx

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    Within the pharmaceutical industry, measurement

    is a major activity. Measurements are taken of: time; linear

    dimensions; mass or weight; temperature; volumeor capacity; velocity or speed; pressure; heat;

    electrical values, such as current, voltage andresistance; and many other things.

    Consequently, there is a high level ofinstrumentation used in the pharmaceutical

    industries.

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    An instrument is defined as the device used to

    measure a parameter (Temperature,pressureetc.).

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    In all cases, the accuracy of the instruments is acritical factor in ensuring that manufacturingcontinues to take place in a controlled manner

    and hence the validated status of all processesis maintained.

    The process of ensuring that instrumentationmaintains its accuracy is known as calibration.

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    The definition of calibration is as follows:

    The set of operations which establish, under

    specified conditions, the relationship betweenvalues indicated by a measuring instrument ormeasuring system, or values represented by amaterial measure, and the corresponding known

    values of a reference standard (EU Guide toGMP).

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    To review the degree of error between areading taken from an operational instrumentand the same reading taken from a standardinstrument.

    To alter the operational instrument in order toreduce the degree of error to zero or anacceptable level.

    Calibration should be considered as one part ofthe ongoing validation of a facility.

    It will cover both the production departmentsand the laboratories.

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    All companies should have a formal programme for the calibration of itsinstruments. In summary, the programme has a number of stages, all of whichneed to be addressed, those stages are:

    All the pieces of equipment that can be defined as instruments areidentified

    BQC013

    A full list of these instruments is produced

    For each one, the appropriate category is identified (critical, major orreference)

    For each one, tolerance and acceptance limits are determined

    Written procedures are developed and authorized. These will varydepending on the category of instrumentation.

    The programme is defined in terms of schedule and frequency

    Responsibilities are assigned for the various calibrations

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    Contracts are set up for any calibrations thatneed to be outsourced.

    Resources, including manpower andequipment, are provided.

    Calibration is carried out and records kept. Calibration equipment is maintained in an

    appropriate manner.

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    All companies prepare their documentation in a manner specific to their ownpolicies and procedures. However, there will be a number of generic documentsrequired for the calibration programme. These will include:

    Master list or inventory of all instrumentation within the company; specificationsrelating to the performance of each instrument.

    Standard operating procedures for the calibration of each type of instrument.

    A planning programme listing the individual calibrations to be carried out(preferably as part of the formal planned preventative maintenance programme ofthe company).

    Records of calibrations that have been carried out internally within the company;calibration certificates issued internally or by external bodies carrying outcalibration on behalf of the company; and training plans and records for thecalibration technicians.

    All calibration records and certificates constitute GMP records and hence should becompleted, stored and archived in accordance with documentation procedures.

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    The purpose of this document is to catalogue allinstruments on a calibration regime and to triggerthe execution of the calibrations at predeterminedtimes. It should contain a:

    record for each instrument requiring periodiccalibration. Each record should include: the last due date, the last calibration date, the

    expiry date, the (next) due date, and the calibrationperiod.

    Wherever possible, due dates should be planned tocoincide with manufacturing plant plannedshutdown dates or preventive maintenance dates.

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    The specification for calibration of an individual instrument isvery important and requires appropriate authorization andcontrol. In particular, there are a number of key factors:

    The category of the instrument

    critical instrument will be treated significantly differently from amajor or a reference instrument.

    Accuracy and range: these should be set to meet the minimumneeds of the parameter being measured.

    Calibration period: this should be arrived at to give a reasonablebalance between over frequent calibration and as-foundfailures.

    It may include consideration of, for example: the durability andstability of the instrument; the required accuracy; the nature of theenvironment and usage; and the degree of criticality of themeasured parameter.

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    The calibration standard operating procedure, which states how to

    calibrate an instrument. It should contain all the instructionsnecessary to ensure that a competent craftsperson following theinstructions will correctly calibrate the instrument.

    Each calibration SOP should have a unique identity and theappropriate one for each instrument should be included on the

    instrument calibration index. The calibration SOP should be signed by the appropriate functions

    within the company to indicate acceptance of the calibrationinstructions, the category rating, the accuracy and range. Thesewould include the instrument specialist, a product or process

    specialist and a representative of quality assurance. Any changes to the format of the calibration SOP should be

    authorized by the same signatories. The revisions should berecorded on a revision-tracking sheet, which should list all thematerial changes from the previous version and a rationale for

    each.

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    This is a record of every calibration report

    produced and should indicate the date it wascreated, the due date, calibrated by whom andpassed failed results

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    Calibrations certificates (report) should only be issued (or adopted ifexternally generated) for calibrations that meet the accuracy requirementslaid down in the appropriate specification.

    Calibration certificates (report) should have a unique certificate number,and give a clear indication of the tag number and plant number ormanufacturers serial number of the instrument.

    Certificates should be traceable to a national standard, by detailing theidentity of the test equipment used; or derived from acceptable values ofnatural physical constants, such as those provided for in British StandardBS EN 300121. They should contain the date that calibration was carriedout, together with the next due date and date of expiry of the calibration.

    There should also be an indication of the person who carried out thecalibration and that persons signature to indicate responsibility for the

    accuracy of the information on the certificate. Externally produced calibration certificates may not have all the above

    information. To be adopted they must have the missing informationadded by hand to complete the minimum requirements. This should beadded by a member of the companys internal instrument group andsigned and dated.

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    The calibration should be carried out following theinstructions in the appropriate calibration SOPs and therequired responses on the worksheet completed.

    First of all, the as-found condition is determined. This isdefined as the accuracy of the instrument over the requiredrange before any calibrating adjustment or repairs are made.If this is outside the limits specified on the calibrationcertificate, it may indicate that faulty product has beenproduced since the instrument was last known to have beencorrect. To address this possibility, a deviation should be

    raised in accordance with procedure. It may also benecessary to place on hold any product batches that mayconsequentially have suspect quality, depending on thenature of the instrument in question.

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    The instrument is then calibrated and a final as-left condition determined. This is defined as theaccuracy of the instrument over the required rangeafter calibration.

    If the as-left condition meets the accuracyrequirements, the calibration certificate iscompleted, and a calibration sticker indicating thecalibration date affixed in a prominent position.

    If the as-leftcondition does not meet the accuracyrequirements, the technician raises a deviation. Thedeviation shall address the controls to be used toensure that the instrument is not used for drugproducts and the actions to repair or replace it.

    The technician shall therefore, in conjunction withdepartmental personnel, establish if it is necessaryto put the associated manufacturing plant onhold to prevent inadvertent usage on drugproducts.

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    When the calibration is carried out and the Reportis completed, the master list is updated to showthe completion date and the instrument calibrationMaster list is updated to the new calibration date.

    All instruments covered by the calibrationprogramme should be calibrated prior to theexpiry date. If a critical instrument were used ondrug products when its calibration has expired, a

    deviation would need to be raised, which wouldaddress the risk to product quality of the batchesmade during the time that the calibration of theinstrument has expired. If such an instrument

    cannot be immediately calibrated or replaced byone that is calibrated, the piece of manufacturingplant to which it relates should be put on holdtoprevent inadvertent usage on drug products unlessan approved deviation allows continued use.

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    Recalibration may be carried out as part ofpreventive maintenance procedures, in which casea calibration SOPs and Master list would not be

    needed. However, a calibration certificate shouldstill be generated.

    External parties (individuals or organizations)

    may be used for calibrating or repairinginstruments. Where they are used, they should bemonitored by internal personnel in order to ensurethat the companys procedure for the control of

    external parties is being met.

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    Absolute standards and international standards: Theseare the ultimate standards against which all referenceequipment is calibrated.

    Primary standard:This is the main reference equipmentused to calibrate the rest of the instrumentation.

    It is either maintained at the appropriate national testinglaboratory or kept at the company, and is used as the

    reference standard against which the company secondarystandards are calibrated. It is generally four times moreaccurate than the secondary standard.

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    Secondary standard: This is the calibration

    standard maintained within the company,which is used to carry out routine calibrations.It is generally four times more accurate thanthe measuring standard.

    Measuring standard: This is the instrumentused for routine measurement and controlwithin the company.

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    The types of equipment found in acalibration laboratory will vary with

    the type of operations that thecompany is carrying out and thetypes of instrumentation that is

    installed around the premises.

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    It is important that calibration equipment isstored and handled in an appropriate manner.

    As a minimum, the temperature and the

    humidity of the calibration laboratory shouldbe controlled.

    The influence of other environmentalconditions such as vibrations should also beconsidered.

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    The frequency of calibration of individual instruments willvary depending on circumstances, such as: the pattern ofusage; the sensitivity of the process being controlled and/ormonitored; the recommendations within the manufacturersoperation and maintenance manual; and the history of

    previous calibration performance. For example, aninstrument that has been shown to maintain its previouscalibration state over a period of more than six monthswould not necessarily need to be calibrated on a quarterlybasis.

    However, the key point to be considered in determining

    frequency of calibration is the process that is beingcontrolled and/or monitored and, in particular, theimportance of the level of accuracy obtained. There are threecategories of instrumentation as follows:

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    Critical instruments: These are instrumentswhose performance will affect both the process

    and the product. An example of such aninstrument would be a temperature control onan autoclave. These instruments wouldgenerally be calibrated at least six monthly.

    Major instruments: These are instrumentswhose performance will affect either theprocess or the product. An example of such aninstrument would be a balance in the

    dispensary. These instruments (and, in thecontext of calibration, a balance may beconsidered as an instrument) would generallybe calibrated at least annually.

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    Reference instruments: These are instruments

    that are installed as reference points only andwhose performance does not affect either theprocess or the product. An example of such aninstrument would be a thermometer in an

    ambient condition warehouse wheretemperature is monitored but not controlled.These instruments would generally becalibrated on installation but not afterwards.

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    When a new instrument is purchased, there are a number ofsteps that should be taken.

    Firstly, the instrument should be identified and theinstrument group informed so that they can issue a tagnumber.

    Secondly, it must be categorized as either critical, major or reference. This categorization and the rationale behind it is

    recorded and authorized, ensuring that the decision isconsistent with company policy.

    All critical instruments should be purchased with current

    calibration certificates that cover appropriate accuracy andrange, and state a specific expiry date. These certificatesmust be traceable to national standards. If certificates cannotbe supplied with the instrument, there will be a need tocarry out initial calibration.

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    On an annual basis, it is a good idea to review the calibrationprogramme to ensure that it is still appropriate and effective.There are two key elements that should be reviewed.

    Firstly, the frequency of calibration of individual instrumentsneeds to be determined. As mentioned above, the history ofprevious calibrations should be taken into account when

    determining the most appropriate frequency of calibration. Theremay be some instruments for which a recategorization isappropriate.

    Secondly, this would be the time to review standard operatingprocedures to determine whether they need to be amended. Forexample, the procedure is generally written such that the

    instrument is tested across the whole of its operational range.However, if an instrument is normally used to measure aroundone focal point in the range, it may be more appropriate toconcentrate the taking of readings around this point.

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    It is necessary to have in place a training programme that coversnot only the people carrying out the calibration, but also thepeople reviewing the data to ensure that there is fullunderstanding. Like any other part of the training programme,there should be a written training plan and full records of all thetraining that has already been completed.

    In this way, the company is able to monitor the skills poolavailable and the ongoing plans to maintain that pool.

    Training should be carried out when a person commences a roleand also on a regular basis thereafter.

    Refresher training on at least an annual basis is recommended inorder to check that standard operating procedures are carried out

    in the correct manner and that no bad habits have been learnedover time. When a new piece of instrumentation is purchased and installed,

    it is important to ensure that all relevant personnel are trained inthe new methodology relating to calibration.