Calibration final in Clean Room facility .ppt

Calibration final in Clean Room facility .ppt

1. Calibration Calibration
ManagementManagement
Prepared by: Ph. Dalia MedhatPrepared by: Ph. Dalia Medhat

2. CalibrationCalibration
Definition:Definition:
The comparison of a measurement system or The comparison of a measurement system or
device of unknown accuracy to another device of unknown accuracy to another
measurement system or device of known measurement system or device of known
accuracy (standard) to detect, correlate, report accuracy (standard) to detect, correlate, report
or eliminate by adjustment any variation from or eliminate by adjustment any variation from
the required performance limits of the the required performance limits of the
unverified system.unverified system.
Comparison
Data
StandardInstrument
unknown Known

3. 
When Calibration should be done?When Calibration should be done?
•Calibration is carried out early in the Calibration is carried out early in the
validation program.validation program.
•Golden Rule: Calibrate, Validate, Golden Rule: Calibrate, Validate,
Calibrate.Calibrate.

4. Calibration ManagementCalibration Management

cGMP Calibration Management cGMP Calibration Management
describes a management system which describes a management system which
defines what needs to be done, when, by defines what needs to be done, when, by
whom and why.whom and why.

A Calibration Management Program A Calibration Management Program
should be available.should be available.

5. 
The key message is that the performance The key message is that the performance
of the instrument is such that there is a of the instrument is such that there is a
high confidence that a process has high confidence that a process has
remained within the desired range.remained within the desired range.
i.e the indicated value + possible deviation i.e the indicated value + possible deviation
will remain within the desired limits.will remain within the desired limits.
Calibration ManagementCalibration Management

6. Calibration RequirementsCalibration Requirements
Qualified Qualified
CalibrationCalibration
managementmanagement
programprogram
RequirementsRequirements
Calibration Master ListCalibration Master List , ,
Proper equipment, accuracyProper equipment, accuracy
Range, periodicity, SOP, Range, periodicity, SOP,
criticality etccriticality etc....
Trained & Qualified personnelTrained & Qualified personnel
to cGMP, Quality, Calibrationto cGMP, Quality, Calibration

7. Examples of Equipment to be Examples of Equipment to be
calibrated:calibrated:

Temperature indicators.Temperature indicators.

Pressure gauge.Pressure gauge.

Flow meters ( Gas & Liquid ).Flow meters ( Gas & Liquid ).

Scales & Balances.Scales & Balances.

Incubators.Incubators.

pH meters.pH meters.

Particle counters.Particle counters.

Sterilizers. Sterilizers.

8. CalibrationCalibration SequenceSequence
11..PreparationPreparation
22..CalibrateCalibrate 33..Fix / Repair / AdjustFix / Repair / Adjust
44..Close-upClose-up

9. 11 . .PreparationPreparation
PreparationPreparation
Calibration RequestCalibration Request
Permission & authority Permission & authority
to perform workto perform work.
SOPSOP
Procedures & dataProcedures & data
Collection formsCollection forms
Correct & calibratedCorrect & calibrated
equipmentsequipments
CalibrateCalibrate

10. CalibrateCalibrate
Scheduled Calibration ReportScheduled Calibration Report
Calibrate to SOPCalibrate to SOP
As-found DataAs-found Data
Close-upClose-up
Fix/Repair/AdjustFix/Repair/Adjust
PassPass
FailFail
22 . .CalibrateCalibrate

11. 33 . .Fix / Repair / AdjustFix / Repair / Adjust
Equipment out of serviceEquipment out of service
( Notify production( Notify production )
Non-conformanceNon-conformance
SuspendSuspend
calibrationcalibration
Calibrate withCalibrate with
adjustmentadjustment
( ( As-left dataAs-left data) )
Close-upClose-up
ApprovalApproval
to fixto fix
YesYes NoNo

12. 44 . .Close-upClose-up
Close-upClose-up
Proper labeling,Proper labeling,
Calibration stickerCalibration sticker
Certification, Paper workCertification, Paper work
Signoff & approvalSignoff & approval
ReschedulingRescheduling
EndEnd
Calibration sticker
 Unique ID
 Calibration date.
 Next due date
 Who calibrated
 SOP… Doc ID…

13. Frequency / Periodicity of Frequency / Periodicity of
Calibration should be based onCalibration should be based on::
1.1. Consequence of Calibration failure.Consequence of Calibration failure.
2.2. Relevant Standards / Regulations.Relevant Standards / Regulations.
3.3.Manufactures recommendations.Manufactures recommendations.
4.4.Historical information.Historical information.
5.5.Experience.Experience.
6.6.Duty of instrument.Duty of instrument.

14. Calibration RecordsCalibration Records

Calibration Records should have a Calibration Records should have a
unique reference no. to identify the unique reference no. to identify the
documentation and documentation and should include:should include:
1. Calibration Request.Calibration Request.
2.2. Certificate of Calibration.Certificate of Calibration.

15. Calibration RequestCalibration Request
1. Date of Calibration1. Date of Calibration
2. Identification of instrument2. Identification of instrument
3. Frequency at which 3. Frequency at which
calibration should be carried outcalibration should be carried out
4. Reference or special 4. Reference or special
instructions used for calibration instructions used for calibration
checkcheck
5. Calibration Range.5. Calibration Range.
66 . .Calibration accuracy and Calibration accuracy and
failure limitsfailure limits..

16. Certificate of calibrationCertificate of calibration
11 . .Date of calibrationDate of calibration6. The “As-found” readings 6. The “As-found” readings
and “As-left” readingsand “As-left” readings
(if adjusted)(if adjusted)
22..Unique reference to the Unique reference to the
request documentrequest document
7.Indication of equipment 7.Indication of equipment
status following calibration status following calibration
(Pass or Fail)(Pass or Fail)
3. Unique identification of 3. Unique identification of
instrument.instrument.
8. Name of person 8. Name of person
approving the product approving the product
critical calibration records.critical calibration records.
4. Calibration range4. Calibration range9. Any necessary 9. Any necessary
calculations that may calculations that may
affect calibrationaffect calibration
5. Calibration accuracy & 5. Calibration accuracy &
failure limits.failure limits.
10. Signature & Date10. Signature & Date
( Audit purposes )( Audit purposes )

17. 
On completion of the calibration the On completion of the calibration the
following action should be taken:following action should be taken:
1.1.The results should be checked to ensure that any The results should be checked to ensure that any
deviation present are within process limits.deviation present are within process limits.
2.2.The documentation should be checked by a second The documentation should be checked by a second
person to ensure that there are no transcription or person to ensure that there are no transcription or
calculation errors and the status of the instrument calculation errors and the status of the instrument
is correct i.e Pass or Fail.is correct i.e Pass or Fail.
3.3.Records showing the history of the equipment Records showing the history of the equipment
including certificate of calibration, failure and including certificate of calibration, failure and
repair should be stored in a safe environment for repair should be stored in a safe environment for
the required minimum period.the required minimum period.

18. Thank YouThank You