Blog

Standard Operating Procedure (SOP) for Handling Procedure of Instrument Calibration in Quality Control Laboratory.

Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by material measure and the corresponding values of the measured.

Handling of Instrument Calibration

1.0   Objective

• • To lay down a procedure for handling of calibration of the various instrument (s) in the Quality Control department.

2.0   Scope

• • This SOP is applicable for the handling of calibration of the various instrument (s) in the Quality Control Laboratory.

3.0   Responsibility

• • Quality Control Chemist/Officer/Executive: Responsible for following the procedure, preparation, updating, tracking, and review of calibration calendar.

4.0   Procedure – Instrument Calibration

• • All the instruments shall be calibrated as per the frequency mentioned in the SOP of the respective Instruments.

• • Preparation, updating, and tracking of Intrument Calibration Calendar

• • Preparation of calibration calendar

• • For the Calibration schedule, QC shall generate a calibration calendar as defined in Annexure – I at the end of the year for the next calendar year.

• • The calibration calendar shall comprise a month-wise calibration schedule (refer to Annexure – I).

• • The calendar shall be signed by the quality control department Chemist/Officer/Executive followed by Head QC or his designee and finally shall be approved by Head QA or designee.

• • Updation of calibration calendar

• • Any addition of the instrument to the calibration calendar shall be done after completion of the Qualification of the respective instrument.

• • The calendar shall be updated with the inclusion of the instrument and shall be commented accordingly in the comment column of the Calendar followed by the signature of the respective department Officer/Executive, Head quality control, or his designee and approval of Head QA /designee.

• • In case of removal of the machines/systems/instrument from the area/facility, the same shall be marked with an asterisk and shall be explained in the comment column followed by the signature of the respective department Officer / Executive / Head quality control or his designee and approval of Head QA /designee.

• • Tracking of Instrument Calibration Calendar

• • The QC- Chemist/ Officer / Executive shall refer to the calendar and arrange for the Instrument’s availability for calibration in coordination with the concerned area to ensure calibration is performed as per the calendar.

• • Once the calibration is performed, the QC- Chemist/ Officer / Executive shall track and update the calendar to indicate the completeness of activity.

• • The same to be done by updating the tag for the respective instrument.

• • The Calibration calendar shall be reviewed for compliance on monthly basis by the Head of Quality control or his designee and shall be signed accordingly.

• • Update the calibration status label (Refer SOP – Status Labeling) on the instruments after completion of calibration.

• • The “cal. due date” on the tag shall be as per the calibration calendar. The calibration due date shall be assigned as follows:

E.g.                Instrument      Calibration Date             Frequency         Cal. due date        

HPLC              02-02-2021                            6 months            02-08-2021            

Friability         02-02-2021                           1 month                02-03-2021          

• • Calibration shall be performed on or before the due date of calibration or unscheduled maintenance/breakdown then the Calibration due date shall be as usual as defined in the calendar.

• • Handling of failure during calibration

• •  If an instrument fails in a particular calibration test then shall be handled as per SOP “Handling of out of calibration”.

• • In the case where the calibration/validation activity is completed in multiple days, the date of calibration/validation shall be taken as the date of completion of the calibration/validation activity.

• • The instruments out of the calibration validity period shall not be used and shall be appropriately labeled to avoid further use.

• • Calibration shall be ensured before the use of this instrument.

• • Instrument performance Qualification / Re-Qualification / Re-Validation / Temp.

• • The mapping study shall be done as per pre-approved protocol. Preparation / Review / Approval of the protocol shall be done as per the Validation Master Plan.

• • For instrument monitored daily for 24 hrs like Stability chamber, Incubator refrigerator and qualification activity required multiple days for an instrument such as autoclave all these instruments may be used for routine usage, during re-qualification / re-validation / temperature mapping as applicable.

• • However, after completion of re-qualification / re-validation / temperature mapping compliance to pre-defined acceptance criteria shall be evaluated.

• • If it fails to meet the criteria, impact assessment shall be carried out with the help of QA.

• • After completion of the activity, the completion date shall be put as a calibration date in the calibration calendar.

• • After completion of calibration activity, the details shall be entered in the respective instrument usage log book.

• • “Instrument Usage Status” as per Annexure-II shall be used as and when an instrument is taken for analysis.

• • Verification of Validity of Calibration standard

• • Validity of calibration standard shall be checked at regular intervals (once in two months) and record the details in Annexure – III.

• • Purchase orders of calibration standards shall be prepared about two months before the expiry or validity date of the calibration standard.

5.0   Annexure – Instrument Calibration

Annexure-I: Calibration calendar

Annexure -II: Instrument Usage Status

Annexure – III: Validity checklist for Calibration standards.