The outlines of the SOP for Calibration Master Plan are the procedures for creating and maintaining a Calibration Master Plan, which serves as a comprehensive framework for managing the calibration activities of instruments and equipment used in various processes within an organization.
To lay down the procedure and guidelines for calibration of all the measuring Instruments/ devices installed.
SCOPE:
This procedure is applicable to all the Equipment /measuring instruments/ devices installed.
RESPONSIBILITY:
Executive/Officer-Engineering or above shall be responsible for proper execution of calibration as per SOP for Calibration Master Plan.
Engineering – Head shall be responsible for reviewing the SOP and for ensuring proper execution as per SOP for Calibration Master Plan.
ACCOUNTABILITY:
Engineering – Head shall be accountable for proper implementation of the SOP for Calibration Master Plan.
DEFINITIONS:
Critical Instruments: All the measuring instruments/devices which are installed on the equipments/machine, those instruments which are directly in contact with product are termed as Critical Instruments.
Non-Critical Instruments: All the measuring instruments/ devices which are installed on non-criticalequipments/ machines, which are not directly in contact with product are termed as Non-critical instruments.
PROCEDURE in SOP for Calibration Master Plan
Selection
Measuring and test instruments shall be identified and selected based on the design parameters of process.
Receipt and Checking
After receiving of instruments from supplier, those instruments shall be inspected for external damage in transit.
These instruments shall be kept safely in the engineering store and shall be calibrated before installation.
Classification of Instruments
Instruments are classified into two categories as given below based on the criticality.
Category
Applications
Critical
This measures the process and product parameters like temperature, conductivity, pH, ORP, Pressure etc.
Non-Critical
Instruments fitted on utility line, Environmental monitoring, etc., Where process doesn’t have direct impact on product.
The List of Measuring Instruments all Critical and Non Critical should be made as per the Format No. SOP/EN/XXXYY
Note: Application, mention instrument is not limited so, it varies according to Process /Product flow.
Calibration Frequency in the SOP for Calibration Master Plan
Calibration frequency shall be decided based on the recommendation of the manufacturer, or by any recognized engineering institution / ruggedness of instruments/ process requirements / past experience.
Those master/Reference Instrument is used for calibration ensure it should be calibrated before use.
Calibration frequency for the two categories of field measuring instruments shall be as given below.
Category
Calibration frequency
Critical
6 months
Non-Critical
1 year
Installation
All new instruments kept in engineering stores shall be calibrated before installation.
Identification numbers for Master instruments and Field measuring instruments shall be given as per SOP No. “SOP/QA/XXXYYY.
Instrument Identification labels shall be attached / affixed to the instruments to give details of instrument identification No. as per SOP No. “SOP/XXXYYY.
Only calibrated instruments shall be installed on equipment / systems.
Calibration status labels shall be attached / affixed to the instrument to give details of date of calibration and due date for next calibration as per Format No.SOP/EN/XXXYYY.
Handling
All instruments shall be handled by qualified and trained personnel to prevent any accidental fall or damage.
Calibration Planin SOP for Calibration Master Plan
List of measuring instruments shall be prepared in computer. Typed format printout shall be taken and signed by Executive /Officer– Engineering in prepared by column, HOD – Engineering in checked by column and QA in Approved by column as per the Format No.SOP/EN/XXXYYY. List of Measuring Instrument for critical and Non Critical Instrument. The same shall be sent to QA for review. After QA review (Reviewed by stamp), photocopies of List of Measuring instruments shall be given to respective area in-charges for their reference through QA.
Frequency for the Updating of Entire List of Measuring instruments is one year. In the event of Addition / Deletion of Measuring instruments in any area of the plant the list of new measuring instruments shall be updated as per Format No.SOP/EN/XXXYYY & for the same shall be maintain in Calibration schedule for new measuring instruments as per Format No.SOP/EN/XXXYYY and same shall be sent to QA for Review. New added instrument will be updated in Annual calibration schedule as per Format No SOP/EN/XXXYYY in every month of December.
An Annual Calibration schedule for the Measuring instruments shall be prepared in computer. Typed format printout shall be taken and signed by Executive or Officer – Engineering in prepared by column, HOD -Engineering in checked by column, User department -HOD in another checked by column and QA in Approved by column as per Format No.SOP/EN/XXXYYY. The same shall be sent to QA for review. After QA review, photocopies of List of Measuring instruments shall be given to respective area in-charges for their reference through QA.
Field Measuring instruments shall be checked for Calibration with in 15 days before the scheduled date for critical measuring instruments and calibration with in 30 days before the schedule date for non critical measuring instruments.
In case clearance is not obtained for calibration of Field Measuring instrument within the stipulated time period the concern user department In-charge shall intimate the next possible date for calibration activity in consultation with QA Department through Inter Office Communication. As per the given date engineering department shall carry out the calibration activity. The same shall be recorded as unplanned deviation.
The Calibration frequency for the Instruments installed in Water system will be matched to the nearest CIP, SIP and Sanitization schedule of the respective systems.
Critical equipment (E.g. Weigh Balance) is maintained through by external party, referred by Corporate Engineering. Weighing balance is maintained department wise.
Weighing balances & Standard weights being used at Production & Warehouse departments shall be stamped with in the due date frequency through H.P. Legal Metrology department as per the Government rules. Calibration frequency for weighing balances – Once in Year and for Standard weights – Once in year. Original stamping certificate will be kept in User department as a support document & same shall be sent to QA for review. After QA review photocopies of the certificate shall be given to respective area in-charges for their reference through QA.
Data logger and Temperature probes shall be calibrated before Validation cycle starts as per the Concerned Equipment User department communication / schedule and Re-calibration shall be done after completion of Particular cycle (Pre & Post Calibration).
Room and Equipment (Like: – Incubator, Stability chamber, Refrigerator, etc.) Temperature mapping data loggers shall be calibrated from External agency twice in year.
PLC validation shall be carried out only once at the time of installation of the concern equipment from external agency. Re – validation will be done if any modifications carried out in the installation (or) installed PLC components (or) Location change of related equipment.
Sterile Production area, Aseptic area related Field Measuring instruments calibration shall be carried out in the same location round the clock basis to complete the Calibrations within schedule time and clearances obtained by concern in-charge.
Note: Some instruments in plant that can be calibrated only at the time of gas fill. Because at the time of calibration when we remove the instrument, in the compressor gas. Due to high pressure of gas exhaust automatically from the point, where gauge opened for calibration purpose. So there is wastage of compressor gases at the time of calibration. Hence calibration shall be carried out at the time of gas fills. Those instruments comes is non critical category & it is excluded from it’s define frequency for calibration.
List of calibration instrument on Lyophilizer which is calibrated at the time of gas filling shall be identified and same list shall be prepared by Executive/ Officer – Engineering checked by In-charge instrumentation and approved by HOD-Engineering as per the Format No.SOP/EN/XXXYYY .The same shall be sent to QA for review.
Calibrationin SOP for Calibration Master Plan
Annual Calibration schedule of instruments shall be prepared as per the Format No.SOP/EN/XXXYYY for the forth-coming year in the month of December.
Based on the requirement of user department the instrument shall be calibrated by an External agency or can be performed using In-house methods.
External Calibration: in Calibrationin SOP for Calibration Master Plan
The Executive/Officer engineering shall be responsible for getting the instrument calibrated from the external party.
Executive/Officer engineering shall inform the external party well in advance about the calibration schedule and about the details of the instrument to be calibrated.
The external party shall be called in the plant premises for performing the calibration.
If the calibration carried out through an external agency the calibration certificates, Master instrument traceability with National Physical Laboratories, National Accreditation Board for Testing and Calibration Laboratories, Electronic test and Development Centre standard certificates and standard operating procedures adopted for calibration shall also be obtained and documented if the external agency provides the same.
In Case Scope of accreditation from NABL were not provided by vendor the respective calibration activities shall not performed till the copy provided by respective vendors.
Engineering Executive/Officer shall collect the calibration certificate of the master instrument for the traceability record.
The external party shall perform the calibration in the presence of the Engineering department person.
After the calibration performed by the external party successfully then prepare and affix their calibration status label on the calibrated instrument as per Format No. SOP/EN/XXXYYY.
The calibration report of the said instrument shall be prepared and send by the external party within 10 working days, from the date of calibration.
If the instrument needs to be sent to the external party, then the instrument shall preferably be replaced with a new calibrated instrument until the original instrument returns back after calibration.
Upon arrival of the instrument, calibration report (along with Traceability of the master instrument) of the instrument shall be checked by the Executive/Officer Engineering. He shall ensure that a proper calibration status label is affixed on the instrument as per the report.
The calibration report should at a minimum have the following data:
Name of Instrument
Identification no. of Instrument / Serial no. of Instrument
Make of Instrument
Result of the calibration
Details of master instrument used for calibration
If the report is found correct, then original instrument shall be placed back to its original position.
Calibration of Instruments by External agencies shall be done as per SOP No. SOP/EN/XXXYYY.
In House Calibration: in Calibrationin SOP for Calibration Master Plan
The Technical Assistance/Officer engineering will carry out the calibration work under the supervision of Executive-Engineering as per the calibration schedule.
The calibration procedure for a specific type of instrument shall be carried out as per respective SOP for calibration of that type of instrument.
The Executive/Officer engineering shall record the data while performing the calibration, either manually OR on the master instrument used for calibration of a particular instrument Engineering department is responsible for the in time calibration of Master Instruments, Plant measuring instruments.
Engineering department shall maintain the Master & Reference Instruments Calibration certificates.
List of Master / Reference instruments shall be prepared in computer. Typed format printout shall be taken and signed by Executive /Officer– Engineering in prepared by column, Checked by HOD –Engineering and Approved by QA as per Format No.SOP/EN/XXXYYY. The same shall be sent to QA for review
Plant measuring instruments shall be calibrated with reference to the Master Instruments as per Annual Calibration schedule
Grace period for the Calibration of Master / Reference instruments is with in 10 Days before the schedule date.
After receiving Master Instruments Calibration certificates from External agency after completion of Re – Calibration, shall be send to QA department for review. After QA review only concerned instrument will be used as a Master / Reference instrument to calibrate the Field Measuring Instruments.
Photocopies of the Master / Reference instrument calibration and Traceability certificate shall be maintained by engineering department as a support document.
List of External Calibration Instruments which cannot be calibrated In-house shall be identified and same list shall be prepared by Executive – Engineering checked by In-charge – Instrumentation and Approved by HOD – Engineering. The same shall be sent to QA for review purpose.
In case any of the Master Instrument is not received within the grace period from the External Calibration Laboratory, Engineering department shall take the Master / Reference instrument from the Supplier / OEM / ILS other units which is similar / Nearer technical specifications to the Master / Reference instrument and carry out the Field Measuring instruments schedule calibration.
After completion of calibration, the Executive/ Technical assistant shall prepare the calibration report as per procedure defined in SOP for calibration procedure of the respective instrument and gets it approved from the Manager/Executive – Engineering.
The calibration report shall be prepared as per Format No.SOP/EN/XXXYYY.
The calibration report prepared should at a minimum have the following contents:
Name of Instrument.
Identification no. of Instrument / Serial no. of Instrument.
Make of Instrument.
Result of the calibration.
Details of master instrument used for calibration.
The old calibration status shall be removed from the instrument and shredded and a new calibration status label (As per Format No.-SOP/EN/XXXYYY) shall be prepared by the Executive/Officer engineering and affixed on the instrument calibrated.
History for all Master / Reference Instruments shall be maintained in the Master Instrument History card as per the Format No.SOP/EN/XXXYYY.
In case of any discrepancy is observed in the instrument or the instrument is not performing as per requirement, the faulty instrument shall be calibrated/replaced with a new calibrated instrument, with a new Identification no.
Note: In case the instrument calibration goes beyond the above-mentioned time limits. In case of deviation, address through as per SOP/QA/XXXYYY.The said deviation shall be approved by Head – QA.
Calibration shall be done by comparing with a standard instrument of known Traceability to National Standards.
If calibration carried out through an external agency the calibration certificates, Master instrument traceability with National physical laboratories (NPL) / National Accreditation Board for Testing and Calibration Laboratories (NABL) / Electronics Test and Development Center (ETDC) standard certificates and standard operating procedures adopted for calibration shall also be obtained and documented if the external agency provided the same.
In case scope of accreditation from NABL were not provided by vendor the respective calibration activities shall not performed till the copy provided by respective vendor.
For instruments that are calibrated in-house, calibration certificates shall be generated.
Engineering department is responsible for the in time calibration.
After completion calibration activity mention the activity in respective log book.
Deviations:
If an instrument is found out of calibration, it shall be brought to the notice of the Quality Assurance department and quality parameters of the products monitored by these instruments since last calibration shall be reviewed by QA to ascertain product quality parameters by means of performing an “Impact analysis”. The out of Calibration Intimation shall be entered as per the Format No.SOP/EN/XXXYYY and submitted to QA for further investigation.
Instruments that are beyond repair shall be scrapped by initiating. Scrap approval form as per Format No.SOP/EN/XXXYYY.
Whenever any instrument is replaced the format should be filled as per Format No:SOP/EN/XXXYYY
Documentation in Calibrationin SOP for Calibration Master Plan
Engineering department shall carry out the calibration as per the schedule and maintain the record of calibration certificates / report (In – house) as per the respective SOP Formats.
Calibration status of the Instrument shall be indicated by Calibration label as per Format No.SOP/EN/XXXYYY.In Calibrated by Column Only Signature will be done by Assistant / Executive – Engineering and at Checked by Column Executive / In-charge – Instrumentation.
Instrument Identification status shall be indicated by Instrument Identification number label as per the Format No.: SOP/QA/XXXYYY.
Ensure the Identification number label & Calibration status label is placed adjacent or on the instrument as applicable after completing the calibration activity.
Calibration record shall be prepared by Executive/Officer/ in charge.
All external and internal calibration certificates shall be checked by engineering department.
Check the calibration reading with respect to the limits on scope of accreditation from NABL (provided by Vendor).
In case scope of accreditation from NABL were not provided by vendor the respective calibration activities shall not be performed till the copy provided by respective vendor.
All calibration certificates shall be verified by Quality Assurance Department by stamping the stamp on the calibration certificates.
All documents related to calibration of instruments retention period shall be 3 years.
List of Calibration SOP’s related to Field measuring instruments shall be prepared.
Reference charts (Used to cross check Like: Temperature sensors, Indicators, Pressure conversions and Conductivity, etc.) are prepare.
INSTRUCTIONSinCalibrationin SOP for Calibration Master Plan
External vendor/party for AMC/service shall be handled by SOP/QA/XXXYYY and SOP/QA/XXXYYY.
Entry and Exit procedure for external party/instruments into the company premises as per following.
Entry and exit procedure for respective area shall be done as per respective SOP.
ABBREVIATIONS:
QA : Quality Assurance
SOP : Standard Operating Procedure
OEM : Original Equipment Manufacture
AMC : Annual Maintenance Contract
REFERENCES:
Deviation Management. : SOP/QA/XXXYYY
Room Number, Equipment/instrument and : SOP/QA/XXXYYY Subcomponent Numbering system.
Personnel Qualification of Aseptic Processing : SOP/QA/XXXYYY Area and Sterility Testing Area.
Management of External Agencies for Outsourcing : SOP/QA/XXXYYY Services.
Calibration of Instruments by External Agencies. : SOP/EN/XXXYYY
DISTRIBUTION LIST:
Calibration in SOP for Calibration Master Plan shall be distributed to following departments Quality Assurance, Engineering as per user request.
ANNEXURES:
Calibration Status Label (External) : SOP/EN/XXXYYY
Scrap approval form : SOP/EN/XXXYYY
Out of Calibration Intimation : SOP/EN/XXXYYY
Master Instrument History Card : SOP/EN/XXXYYY
Instrument Replacement Record : SOP/EN/XXXYYY
Calibration Schedule Format : SOP/EN/XXXYYY
List of Measuring instruments : SOP/EN/XXXYYY
Format for New Measuring Instrument : SOP/EN/XXXYYY
List of Master Instruments : SOP/EN/XXXYYY
List of External Calibration Instruments : SOP/EN/XXXYYY
Calibration Status label (In house) : SOP/EN/XXXYYY
Calibration Certificate format : SOP/EN/XXXYYY
List of Instrument Calibrate at Time of Gas Filing : SOP/EN/XXXYYY
Calibration Schedule For New Measuring Instruments : SOP/EN/XXXYYY
FORMAT FOR CALIBRATION STATUS LABEL (EXTERNAL) inCalibrationin SOP for Calibration Master Plan
COMPANY NAME & ADDRESS:
CALIBRATION STATUS
Name of the instrument
Instrument ID no
Calibration Date
Calibration due date
Location
Calibrated by
SCRAP APPROVAL FORM in Calibrationin SOP for Calibration Master Plan
S. No.
Name of the Instrument
Instrument ID No.
Date of scrapping
Reason for scrapping
Raised by
Approved by
OUT OF CALIBRATION INTIMATION NOTE inCalibrationin SOP for Calibration Master Plan
Instrument Details
Name of the Instrument
Instrument ID Number
Name of the Equipment
Equipment ID Number
Out of Calibration Details
Acceptance Criteria
Calibration Results
Calibration Done By
Calibrated on
Last Calibration Details
Acceptance Criteria
Calibration Results
Calibration Done By
Calibrated on
Impact Analysis by QA with User Department
Review of Calibration Frequency, if any
Name
Signature
Date
Investigated By
MASTER INTRUMENT HISTORY CARD in Calibrationin SOP for Calibration Master Plan
Master / Reference Instrument name
Master Instrument ID No.
Location
Sr. No.
Date
Description
Remarks
INSTRUMENT REPLACEMENT RECORD inCalibrationin SOP for Calibration Master Plan
Equipment Name
EquipmentID No.
DETAILS OF EXISTING INSTRUMENT
DETAILS OF NEW INSTRUMENT (REPLACED)
Impact on Product Quality (Yes/No)
Done By
QA Approval
Remarks
ID No.
Make
Date
Make
Calibration Date
Calibration Certificate No.
ANNUAL CALIBRATION SCHEDULE
Equipment Name & ID:
S.NO.
Instrument name
I.D. No.
January
February
March
April
May
June
July
August
September
October
November
December
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
Sch. date
Act. date
LIST OF MEASURING INSTRUMENTS
EQUIPMENT NAME & ID :
S. No.
Instrument Name
Instrument ID.
Make
Range
Operating Range
Least Count
Accuracy
Location
Calibration Category
Calibration Frequency
Prepared By: Engineering
Checked By: Engineering
Approved By: Quality Assurance
Name
Signature
Date
ADDENDUM SHEET FOR NEW MEASURING INSTRUMENTS
EQUIPMENT NAME & ID:
S. No.
Instrument Name
Instrument ID No.
Make
Range
Operating Range
Least Count
Accuracy
Location
Calibration Category
Calibration Frequency
Prepared By: Engineering
Checked By: Engineering
Approved By: Quality Assurance
Name
Signature
Date
LIST OF MASTER INSTRUMENTS
S. No.
Name of the Instrument
Instrument ID No.
Instrument serial number
Make
Range
Calibration Cert. no.
Calibration date
Calibration due date
PREPARED BY: ENGINEERING
CHECKED BY:ENGINEERING
APPROVED BY: QUALITY ASSURANCE
Name
Signature
Date
LIST OF EXTERNAL CALIBRATION INSTRUMENTS
S. No.
Name of the Instrument
Instrument ID No.
Make
Range
Operating Range
LeastCount
Accuracy
Location
Calibration frequency
PREPARED BY
CHECKED BY
APPROVED BY
Name
Signature
Date
TEMPLATE FOR CALIBRATION STATUS LABEL (IN HOUSE)
FLAIR PHARMA
ENGINEERING DEPARTMENT
CALIBRATION STATUS
Name of the instrument
Instrument ID No.
Calibration Date
Calibration due date
Location
calibrated by
Verified by
CALIBRATION CERTIFICATE
DETAILS OF UNIT UNDER CALIBRATION
INSTRUMENT:
DEPARTMENT:
MAKE:
INSTRUMENT ID:
RANGE:
LOCATION:
LEAST COUNT:
EQUIPMENT NAME:
OPERATING RANGE.
EQUIPMENT ID:
ACCURACY:
CALIBRATIONDATE:
NEXT DUE:
CALIBRATION PROCEDURE NO.:
DETAILS OF CALIBRATION STANDARD(S) USED
NAME & MAKE
SR. NO.
RANGE
ACCURACY
CERTIFICATE NO.
DUE DATE
OBSERVATIONS
REMARKS
CALIBRATED BY
CHECKED BY
REVIEWED BY
VENDOR SIGN.
VENDOR SIGN.
XXXYYY
LIST OF INSTRUMENTS CALIBRATE AT THE TIME OF GAS FILLING
