Calibration Program – SOP & Policy

Standard Operating Procedure (SOP) and Policy/Program for Calibration of Instrument, Equipment, and Measuring Device used to measurement, monitoring, and controlling of operation and process in different departments at the Pharmaceutical Drug Manufacturing Plant.

Calibration is a set of operations that establish under specified conditions, the relationship between values indicated by a measuring instrument or measuring system or values represented by a material measure and the corresponding values of a quantity realized by a reference standard.

Calibration Policy of Instrument, Equipment & Measuring Device

1.0   PURPOSE :

    • To define the policy for calibration of all master instruments and measuring devices used for measuring, monitoring, and controlling of operations and process.

2.0   SCOPE – CALIBRATION POLICY :

    • This SOP is applicable for the in-house or external calibration for all the master instruments, all measuring equipment, testing equipment, process control equipment used in, stores, manufacturing, Packing, Engineering, Q.C. used at Pharmaceuticals Plant.
    • The scope of this SOP, however, does not cover the calibration of QC equipment like HPLC, Gas Chromatograph, pH meter, etc. (For Calibration of Laboratory Instrument, Refer SOP for Internal and External Calibration)

3.0   RESPONSIBILITY – CALIBRATION POLICY :

    • Instrumentation Engineer: to ensure CAL of instruments as per schedule.Equipment Calibration
    • Head – Utility: Compliance to CAL schedule and plan.
    • Head – Quality Assurance: Compliance to the procedure.

4.0   DEFINITION (S)

    • Calibration: It is the process of comparing reading on one piece of equipment or system, with another piece of equipment that has been calibrated and referenced to a known set of parameters.
    • Accuracy: The closeness of agreement between an observed or measured value and accepted reference value.
    • Measurement standards: A measuring instrument or material, which physically defines a unit of measurement or value of a quantity.  Measurement standards should usually be traceable to a national or international standard.
    • Critical Instruments: The instrument, which gives a direct impact on the product.
    • Non-critical Instrument: The instrument, which does not have a direct impact on the product and is optional.

5.0   PROCEDURE – CALIBRATION POLICY :

    • All master instruments shall be calibrated at least once in a year or as desired in case of special requirement and shall be traceable to national standards like NPL or NIST or international standards.
    • All measuring and monitoring devices/instruments are calibrated either internally or by an approved external party.
    • Instruments calibrated internally shall include e.g.

      • Pressure gauge (0 to 30 kg/cm2), Pressure switch, Vacuum gauge,
      • Temperature sensors, Digital temperature indicators, Temperature controller,
      • Glass thermometers, Temperature gauge, Timer,
      • Tablet counter, Stopwatch, RH controller,
      • pH sensor, pH meter, The transmitter of pH,
      • Data loggers, Oxygen analyzer, RPM meter,
      • Chart recorder, Micrometer,
      • Magnehelic gauge, Digital thermometer, Digital Vernier caliper, and Conductivity transmitter.
    • On satisfactory completion of CAL, the “CALIBRATED” tag shall be attached as per the respective format.
    • Master instruments to be calibrated from an external agency shall be maintained as per Annexure-I.
    • All the masters/measuring instruments that are to be calibrated from an external agency shall be sent either to the CAL agency or the agency shall be called for the calibration.
    • CAL certificates received from the external agency shall be filed separately and an external calibration tag shall be affixed on respective master/measuring instrument.
    • All certificates received from external agencies shall be verified by the concerned engineer responsible for calibration.
    • Calibration (CAL) of newly installed measuring instruments

    • The concerned department during the qualification of new equipment shall inform the Utility Department for new measuring instruments.
    • The engineer concerned with the equipment then checks for the measuring instruments on that particular equipment.
    • The engineer checks for the supplier/factory equipment CAL certificate.
    • If available, then CAL tag is fixed. Also, an identification number is given to the new instrument, which is cross-referenced on the supplier’s equipment calibration certificate.
    • If the supplier equipment CAL certificate is not available then the new measuring instrument(s) is calibrated before use as per relevant SOP(s).
    • The calibrated instrument is given a new identification number, calibrated, and CAL certificate is prepared for the same.
    • The new identification number is then updated in the index sheet of Additional Gauges / Instruments CAL Planner cum Schedule (Annexure-III) and shall be subsequently updated in the Annual calibration Schedule of the subsequent year.
    • In case any new master/measuring device is introduced/ added after the preparation of the annual calibration plan, it shall be recorded in “Additional Gauges / Instruments CAL Planner cum Schedule” (Annexure-III).
    • At the end of the calendar year, the new addition master/measuring instrument shall be incorporated from next year’s schedule for calibration.
    • In case any new master/measuring device is removed after the preparation of the annual calibration plan, it shall be recorded in “Deletion of Measuring Instruments CAL Schedule” (Annexure-V).
    • At the end of the calendar year, the deletions shall be updated in schedule cum plan for next year.
    • Procedure for Equipment Log-out

    • Utility Department shall be informed about the equipment to be removed.
    • The concerned Engineer then checks for the measuring instruments on concerned equipment.
    • It shall be recorded in form “Deletion of Measuring Instruments Calibration Schedule” (Annexure-V).
    • Action to be taken if any instrument is found out of calibration limits.

    • At the time of CAL, if any instrument is found out of acceptable limit “OUT OF CALIBRATION” label shall be pasted on the equipment as per respective format.
    • In such a case, an additional calibrated device of the type shall be incorporated in its place till the measuring devices are received after calibration.
    • On receipt of the calibrated devices, it shall be incorporated and documented.
    • If the instrument remains unfit for use, the instruments shall be removed by a new calibrated instrument.
    • If any of the measuring devices found to be out of order during operation, the same shall be taken for correction and calibration.
    • It shall be further incorporated only if the result found to be satisfactory.
    • In case, the correction is not done, it shall be replaced by another calibrated measuring devices.
    • Location Change of Equipment 

    • If the location of the measuring instrument is changed from one equipment to another, the same shall be done after approval from QA.
    • A remark of change of location shall be mentioned on the certificate.
    • At the time of recalibration of the instrument, the CAL certificate and the tag will be updated as per the new equipment code number and its location.
    • Equipment Calibration Frequency:

    • The frequency of calibration is based on the criticality of measurement; the risk associated with failure or inaccuracy, history of equipment as per reliability, or manufacturers’ recommendations. (Refer SOP for Quality Risk Assessment)
    • The CAL frequency is 6 months/ half-yearly for critical equipment and for equipment directly related to processing and not more than 12 months/ yearly for non-critical equipment.
    • Perform In-house CAL of equipment within 7 days of its scheduled date.
    • Complete the Calibration from the external party within 15 days of its scheduled due date.
    • e.g. If a gauge has a schedule CAL date of 10.08.2020 and has a frequency of one year, then the next calibration shall be done within ±7 days of scheduled date.
    • In case, the calibration of any measuring devices is not be completed as planned due to unforeseen reasons, it shall then be completed in the next 15 days for in house calibrated instruments and 30 days period outside calibrated instruments respectively.
    • Control the activity a “Request for Extension Calibration Date of Instrument/ Gauge” (Annexure-VI).
    • Documentation of Calibration Activity :

    • Calibrate all instruments in-house or from the external agency as per the Annual calibration plan (Annexure-II).
    • The utility department based on the frequency of various measuring devices shall prepare the Annual CAL plan.
    • The plan shall verify by Utility head and approved by Head, Plant, and Head, Quality Assurance.
    • Based on the Annual calibration Plan, the Annual Calibration Plan and Schedule (Annexure-II) shall be prepared by the Utility department.
    • The schedule shall verify by Head, Utility, and Approved by Plant Head and Head, Quality Assurance.
    • The CAL of the measuring devices shall perform as per respective SOP.
    • For each in-house CAL, a calibration certificate shall generate as per the format defined in Annexure-VI.
    • For those measuring devices, which are calibrated from external agencies, the certificate number shall be the same as mentioned in the test certificate issued by the external agency.
    • The in-house calibration certificate number shall be in the format CAL/XXX/YY/NNN
      • The pattern for the certificate number shall be given as follows:

      • CAL: Stands for calibration certificate.
      • /           : stands for forward slash
      • XXX: Department code where the instrument is available.
      • /           : stands for forward slash
      • YY: Year of calibration e.g. 14 for 2014
      • /           : stands for forward slash
      • NNN: Serial number of the certificate starting from 001

Example -1: First calibration certificate issued in the year 2020 for the utility shall be: CAL/UTC/20/001.

    • During the preparation of the CAL certificate, details like serial number, range, least count, CAL date, and due date shall be recorded along with acceptance criteria, details of the standard instrument, reading before and after calibration wrt standard.
    • The variation observed from the reading of master instruments during CAL of instruments like Temperature controllers, temperature indicator, chart records, RPM meters, RH controller, Temperature and RH indicator, ampere meter, voltmeters, frequency meter, level transmitter, pressure transmitter, pressure gauges, temperature gauge, shall be a corrected as per the standard input value of the master instrument.
    • Record the same in the CAL certificate (Annexure-VI).

6.0   ABBREVIATION (S)

    • NPL: National Physical Laboratory
    • NIST: National Institute of Standards and Technology

7.0       REFERENCE (S)

    • SOP for  “Document and Data Control”

8.0       ANNEXURE (S) – CALIBRATION POLICY :

    • Annexure-I: List of Master Instruments

Sr. No. List of Master Instrument Instrument ID No.
    • Annexure-II: Annual Calibration Plan and Schedule

Department:                                                                                                    Year:

S. No. Inst. Name ID No. Location Make /Inst.  Sr. No. Range

 

Least Count Freq. Scheduled  Date Done Certificate No.

On

By

    • Annexure III: Additional Gauges / Instruments calibration Schedule cum Planner

Sr. No. Inst. Name ID No. Location Make / Inst.  Sr. No. Range Least Count
Freq. Sch.  Date Done Certificate No. Compiled by
On By
    • Annexure-IV: Format for Calibration Certificate

Instrument: ………………………………………………………… Certificate No.: ………………….………………..              

Make: …………………………………………………………………. SOP Ref. No.: …………………………………..…

Instrument ID: …………………………………………….………… Serial No.: …………………………………………

Range: ……………………………………………….….………        Cal. Date: …………………………………………..

Least Count: ……………………………………………….… ..       Due Date: …………………………..………………

Acceptance Criteria: ……………………………………..……..      Location: …………………………………                   

Unit of Measurement: …………………..……………………..

Remarks: …………………………………

UUC / STD. Reading

UUC / STD. Reading

 

Environmental Condition during CAL: Temp. ……… (ºC) Relative Humidity ……… (%)

Detail of Standard Instrument Used for CAL:

Instrument Name Make Range Certificate No. CAL Due On
    • Annexure V: Deletion of Measuring Instruments Calibration Schedule

Sr.No Instrument Name Instrument ID No. Location Range Least Count Freq. Reason for Deletion Date of deletion Compiled By (Sign/ Date)
    • Annexure VI: Request for Extension Calibration Date of Instrument/ Gauge

Initiated on Initiated by
Type of instrument:
Identification number:
Location/area:
CAL due on:
CAL expected by:
Justification for Extension of CAL:

Head Utility. (Sign/Date)

Disposition of Quality Assurance

Extension of CAL approved/ Not approved Head, Quality Assurance (Sign/ Date)

Verification After CAL
Actual CAL Done on CAL Certificate No.
Status of After CAL:
Reviewed By (Utilities):                     
Approved By
Head, Utilities (Sign/ Date) Head, Quality Assurance (Sign/ Date)

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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