SOP For Calibration Policy of Equipment and Instruments

It is the policy of Pharmaceuticals Limited that the written procedure shall be followed for calibration of all Equipment/ Instrument at suitable intervals based on the manufacturer’s recommendation, historical experience, and criticality of use, used in the process of Manufacturing, Packing, Analytical division., Maintenance and Warehouse other than those Equipment / Instrument that are calibrated with each use.

This procedure is to be applied at the time of preparation of the calibration schedule once in a year for both house calibration and party Calibration. The instrument/equipment is to be calibrated as per their individual frequencies stated in the calibration schedule.

RESPONSIBILITY

Persons along with their responsibilities are given below:

S. No

Designation

Responsibility

01

Executive – Corporate Quality Assurance

To prepare procedures and coordination for calibration with the Outside party and concerned department.

02

Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst

To follow the SOP accordingly

03

Executive – Quality Assurance

To prepare in-house and outside calibration schedule

 

04

Manager – Quality Control

Execution and overall responsibility for calibration with an Outside party and concerned department

05

Manager – Quality Assurance

To ensure that calibration is being done accordingly.

06

Manager – Corporate Quality Assurance

To ensure the implementation of SOP

PROCEDURE

Separate calibration programs for in-house calibration and outside-party calibration shall be prepared at the beginning of each year for all instruments/equipment to be calibrated on dates as per their individual frequencies.

Calibration of Equipment / Instrument shall be carried out at suitable intervals based on the manufacturer’s recommendation, historical experience, and criticality of use.

Calibration standards for in-house or contract service must be traceable to a recognized National Standard and within the calibration validity period.

All traceability certificates shall be checked by the Department Head and reviewed by a person responsible for calibration activities.

Both In-house and outside calibration schedules shall be prepared by the concerned departments as per Annexure I (Format for Outside Party Calibration Schedule) and Annexure II (Format for In-house Calibration Schedule) and shall be handed over to the Quality Assurance Department.

The quality assurance Department on receiving schedules from the different departments will prepare a composite Schedule for calibration and will send a copy of the same to all concerned departments. 

On installation of new equipment, during qualification, all instruments that need to be calibrated shall be identified based on manufacturer recommendation and criticality of use. The user department will inform to Quality Assurance Department about the same for inclusion in the calibration schedule on Appendix - I.

On procurement of new measuring instruments like, thermometers, Thermo hygrometers, etc. the user department will inform to Quality Assurance Department for inclusion in the calibration schedule in Appendix-I.

Once the instrument is included in the calibration schedule, the Quality Assurance Department will allot new ID no. of that series based on the type of instrument and will inform the concerned department.

The user department will inform to Quality Assurance Department about 30 days before the due date of calibration for outside party calibration so that necessary arrangements can be made in Appendix III.

All concerned departments are required to inform the Quality Assurance Department whenever any instrument is replaced, out of use, damaged, out of calibration, or when there is no calibration status label.

The calibration schedule (both in-house and outside) will be a live document and any inclusion can be made manually.

Although all efforts will be made to calibrate the instrument/equipment on or before due dates the following grace periods will be accepted based on the criticality and frequency of calibrations:

Monthly: 1 Week

Quarterly: 1 Week

Half-yearly: 2 Week

Yearly: 4 Week

The schedule shall have the following information:

Names of instrument/equipment                   

Identification Nos. (ID Nos.)                        

Frequency of calibration

Outside Party Calibration

In the case of outside party calibration, a technical contract shall be signed with the party specifying the general conditions of calibration using agreed methods.

Calibration shall be carried out at the site in presence of a supervisor/officer of the concerned department.

If calibration is not possible at the site, shall be sent to the site of an outside agency.

Calibration of Equipment / Instrument shall be carried out as per the Standard Operating Procedure.

HOD of the concerned department shall ensure that calibration is being carried out as per SOP.

If any equipment/instrument is found out of calibration, label it as “UNDER MAINTENANCE”, update the Instrument History Card as per Appendix II and inform Quality Assurance for appropriate action.

In case the instrument is out of calibration it gets promptly reported and steps are taken to remove it from service.

Instrument/equipment shall not be further used till complies with the calibration requirements.

The acceptance criteria for calibration of instrument/equipment shall be provided by the company to the outside party agent.

On the successful calibration of any equipment/instrument, the calibrating agency personnel shall label the instrument with a calibration sticker.

The calibration sticker shall have information like date of calibration, Instrument ID No., Calibration date, a signature of the person who carried out the calibration, and the next due date of calibration.

The calibrating agency shall issue a certificate of calibration in respect of each instrument/equipment calibrated.

The calibration certificate shall have details like identification of the instrument, the range of calibration, standard calibrators used and their traceability, the date of calibration, the actual values obtained, the date on which the next calibration is due, and the signatures of the person who carried out the calibration activity.

Each certificate of calibration of instrument/equipment shall be reviewed by the concerned Department.

Along with these calibration certificates, the calibrating agency shall also provide copies of the calibration certificates of the standard calibrators used, traceable to National Standards.

All traceability certificates shall be checked by the Department Head and reviewed by a person responsible for calibration activities.

Ensure that resolution (least count) of calibrator should be less than the resolution of equipment/instrument to be calibrated.

The certificates shall be documented & maintained in the record.

SOP for Calibration Policy

In house Calibration

A calibration schedule shall be prepared at the beginning of each year for all instruments/equipment to be calibrated as per their individual frequencies.

Calibration of instruments shall be done as far as possible in the location of its use.

In case the instrument/equipment is found out of calibration, it shall be immediately labeled “UNDER MAINTENANCE”, update the Instrument History Card as per Appendix II and inform Quality Assurance for appropriate action.

In case the instrument is out of calibration it gets promptly reported and steps are taken to remove it from service.

Instrument/equipment shall not be further used till complies with the calibration requirements.

After successful calibration, the instrument shall be labeled with a Green calibration sticker indicating the Instrument name, date of calibration, Tag No. / ID No., the signature of the person who carried out the calibration, and the next due date of calibration.

Calibration reports shall be prepared by the person carrying out the activity and shall be reviewed by the designated person and documented.

Maintenance or moving of an instrument can alter the calibration status and accuracy of data. Hence any such activity with the instrument shall be assessed and recalibrated (whenever required) and the calibration record.

Re-calibration shall be done in case of any maintenance or re-installation of instrument/equipment (wherever applicable) and the record shall be maintained.

FOLLOW-UP FOR OUT OF CALIBRATION

 The details of ‘Out of Calibration’ shall be recorded in the logbook of the respective instrument/equipment and informed to the Quality Assurance Department. 

Fill out the form on SOP JOB ORDER attached in Annexure IV and send it to the engineering department.

HOD – Engineering shall take corrective action accordingly.

The QA person shall assess the number of Samples affected or the number of analyses affected and the impact of the same on the quality or system.

Record the maintenance details in the log of the instrument/equipment.

Calibrate the instrument/ equipment after rectification as per the respective calibration SOP.

>List of Standard Operating Procedure

Record the calibration in the log of the instrument/equipment

  ANNEXURE - I

S. No.

Instrument

 Instrument ID

Calibration Frequency

J

A

N

F

E

B

M

A

R

A

P

R

M

A

Y

J

U

N

J

U

L

A

U

G

S

E

P

O

C

T

N

O

V

D

E

C

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEXURE-II

S. No.

Instrument

Instrument ID

Calibration Frequency

J

A

N

F

E

B

M

A

R

A

P

R

M

A

Y

J

U

N

J

U

L

A

U

G

S

E

P

O

C

T

N

O

V

D

E

C

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 APPENDIX -II

S.No.

Date of Observation

Problem Found

Corrective Action

Rectified On

Rectified By

Checked By

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REQUEST FOR NEW INSTRUMENT I

Name of Instrument ……………………………………………………………………………….

Date of Qualification ………………………………………………………………………………

Details of Instrument ……………………………………………………………………………...

……………………………………………………………………………………………………

……………………………………………………………………………………………………

Department ………………………………………………………………………………………….

Instrument ID ……………………………………………………………………………………….

Requested By:                                      Checked By:                                    Approved By:

(Section In-Charge)                            (Manager Technical)              (Manager Quality Assurance)

INSTRUMENT HISTORY CARD

Name of Equipment:…………………………………………………………

Instrument ID: …………………………………………………………………

APPENDIX III

REQUISITION FOR CALIBRATION THROUGH OUTSIDE PARTY

Requested to: …..

Requested by: …………………………………………………………………………..

Name of Instrument: …………………………………………………………………..

Instrument ID:……………………………………………………………………………

Date of Last Calibration:………………………………………………………………

Due date of calibration:………………………………………………………………..

Prepared By:                                                 Approved By:

 APPENDIX IV

JOB ORDER

Requested By: ………………………………………………………………………………

Requested To: ………………………………………………………………………………

Name of Instrument: …………………………………………………………………………

Instrument ID: …………………………………………………………………………………

Details of Instrument: ………………………………………………………………………

Fault in Instrument: ……………………………………………………………………………

………………………………………………………………………………………………

Prepared By:                    Checked By:                                        Received By:

BANTI SINGH

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