calibration policy for equipment and instruments

1.0 OBJECTIVE :

1.1 To lay down a procedure for calibration policy of all the testing and measuring instruments used to measure critical processes which can have impact on the quality of the product.

2.0. SCOPE :

2.1 This procedure covers calibration of measuring instruments used in Pharma done by outside agencies.
2.2 This procedure also covers the calibration procedure of certain measures instrument calibrated using in house procedure. .

3.0. RESPONSIBILITY :

3.1 QA manager/head shall be responsible for conduct the calibration program as per schedule.

3.2 QA officer/executive shall be responsible to verify the status of all the measuring instruments during calibration

4.0. ACCOUNTABILITY : QA Head.

5.0. PROCEDURE :

CALIBRATION BY QUALIFIED OUTSIDE AGENCY:

5.1 QA Manager or designee shall prepare list of measuring items to be calibrated by outside agency as per
annex-I [List of Instruments calibrated by Outside agency.]
5.2 QA Manager or designee shall prepare yearly planner of items to be calibrated by outside agency as per
annex-II. [Calibration Schedule For Instrument (Outside Agency]
5.3 Outside agency shall calibrated measuring instrument as per their SOP and shall give reports to QA manager
or designee.
5.4 QA manager shall compile such reports in annex-III [Details of calibration Data (Outside Agency Report)]

5.5 QA manager or designee shall ensure that all new measuring equipments procure in the company shall have duly authorized initial calibration certificate.

CALIBRATION PROCEDURE(IN-HOUSE)

5.6 QA manager or designee shall prepare list of measuring instruments/items department wise for in house calibration as per Annex-IV [List of Instruments Calibrated by Inhouse (Fast Pharma)]
5.7 QA manager shall prepare yearly planner of such measuring instruments as per annex-V inhouse[Calibrated Schedule For instruments.(Inhouse)].
5.8 Head GLP or designee shall prepare yearly planner of QC instruments as per SOP.
5.9 All records of calibration (Inhouse) of operation and QC measuring instrument shall be recorded in the respective annex of individual SOP of measuring instrument.
5.10 Calibration tag shall be changed by QA personnel after recalibration of measuring instruments by in house or by Outside agency.
5.11 Damaged measuring instruments shall be removes from the service till they are repaired and recalibrated.
5.12 Calibration frequency as specified in Annex –I [List of Instruments calibrated by Outside agency.] and Annex-IV List of Instruments Calibrated by Inhouse

6.0 ABBREVIATION :

Sr. No.	Abbreviation used	Full form of abbreviation used
1	Mfg.	Manufacturing
2	No.	Number
3	QA	Quality Assurance

7.0 ATTACHMENTS (ANNEXES) :

Annex – I : List of Instruments calibrated by Outside agency.
Annex -II : Calibration Schedule For Instrument (Outside Agency)
Annex -III : Details of calibration Data (Outside Agency Report)
Annex – IV : List of Instruments Calibrated by Inhouse
Annex -V : Calibrated Schedule For instruments.(Inhouse)

8.0. REFERENCE :