1.

0 OBJECTIVE
Objective of this SOP is to establish the standard procedure for Calibration of Process and Utility
Instruments.

2.0 SCOPE
This Procedure shall be applicable for calibration of all process and utility instruments installed at
THINQ Pharma -CRO Limited Pithampur location.

3.0 RESPONSIBILITIES

3.1 Officer/Sr. officer –Engineering shall responsible for timely calibration of process and utility instrument

as per SOP.

3.2 Engineering In-charge shall responsible for implementation and compliance of SOP

4.0 PROCEDURE
4.1 To ensure an instrument is providing accurate measurement and its accuracy is in defined
acceptance range, a periodic calibration shall be carried out.

4.2 Instrument annual calibration schedule plan shall be prepared by engineering department for in-
house calibration as well as calibration performed by outside agency.

4.3 List of Instrument in Annexure No.ENG008/A01/R0 shall be calibrated by certified outside agency.

4.4 Separate standard operation procedure shall be prepared for calibration of Instrument which needs
periodic in-house calibration with mentioning the calibration schedule and acceptance criteria.

4.5 Calibration shall be done using certified calibration standards traceable to National/NIST standards
either in-house or from a certified outside agency.

4.6 Annual calibration schedule plan shall be prepared as per format no.ENG008/F01/R0.

4.7 Calibration due date and done date shall be mentioned respective month by following pattern

Where,
X: due date
Y: Done date

4.8 Calibration shall be carried out in between their grace period without any deviation. If due date falls
on holidays / weekly off’s calibration shall be performed before the due date.

4.9 When calibration is performed by outside agency, collect the calibration certificate from the agency
and letter the certificate shall be verified by engineering department.

4.10 During calibration, tag the Instrument/Equipment with “Under Calibration “label.

4.11 The Instrument/Equipment “Under Calibration” shall not be used.

4.12 If the Instrument/Equipment passes the calibration test, put “Calibrated” label duly filled as per
Annexure no.

4.13 In case the Instrument/Equipment fails the calibration, failure shall be investigated by concerned
personnel as per deviation management system.
4.14 In case a calibration is performed due to a breakdown, repair, change of parts or any other reason,
before the next due date of calibration, the same shall be recorded in the respective calibration
record.

5.0 The scheduled date of calibration shall not be disturbed due to any calibration performed before the
scheduled date of calibration.