sop for calibration policy

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5 years ago

sop for calibration policy

1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for calibration and maintenance of equipment, measuring and monitoring device along with desired documentation as per cGMP norms.
2.0 SCOPE
2.1 This SOP is applicable for all the equipment / instrument handled and maintained
3.0 RESPONSIBILITY
3.1 Officer / Executive – Quality Assurance: Prepare the SOP and follow up the standard operating procedure accordingly.
3.2 Head – Quality Assurance: Provide the support to the implementation of SOP and maintaining the record.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance
5.0 REFERENCE(S)
5.1 In-House

6.0 PROCEDURE
6.1 Precautions
6.1.1 Do not use non calibrated equipment / instrument
6.2 Equipment – Calibration & Maintenance
6.2.1 Manufacturing equipment shall be qualified for intended services and it shall be assigned a unique Tag. No. as it’s identity. QA team will be responsible for assigning the specific Tag No., maintain record and the list.
6.2.2 QC department shall perform the qualification of analytical instrument / equipments installed in the laboratory. QC department shall assign tag no. independently & maintain the record.
6.2.3 Calibration of engineering / utility equipment / instrument will be done by engineering department. Engineering department is also responsible for assigning tag no. and calibration of measuring gauges and timers attached with the equipment or area.
6.2.4 Each and every equipments shall have SOP for it’s operation as well as calibration along with precautions to be followed.
6.2.5 Calibration record of equipments shall be maintained by the user department. The record shall contain the following:
• Reference SOP
• Calibration Record
• Acceptance Criteria
6.2.6 Maintenance record of equipment will be maintained separately.
6.2.7 Calibration & qualification of equipment, apparatus, gauges and recording devices will be done at defined frequency. However, when equipment is in operation and / or for any other reasons calibration could not be done at due period, a permissible deviation shall be follows:
Calibration Frequency Permissible Deviation
Daily No Deviation
Monthly 3 Days
Quarterly 15 Days
Half Yearly 15 Days
Yearly 30 Days

6.2.8 Due to any reason, if calibration due date exceeds the above – mentioned permissible deviation, the delay in calibration shall be authorized by Head – QA under deviation.
6.2.9 When the instrument is not in use, due to no activity in the area, daily calibration of equipment (e.g. Weighing balances, pH meter etc.) is not necessary. In the calibration record no activity shall be mentioned. However prior to start up of the activity, equipment shall be calibrated.
6.2.10 Any calibration done by external person / party shall be recorded in calibration register. The supervisor will ensure that equipment is calibrated before taking it into operation concerned department’s personnel.
6.2.11 “Calibration Tag” shall be tagged on all equipment. The tag shall contain information like Equipment ID No., date of calibration, due date of calibration, signature of calibrating person. Calibration tag attached as an Format No.
6.2.12 Annual calibration planner shall be maintained for all the equipment as per Format No.
6.3 External Certification of Weights & Measuring Devices :
6.3.1 Weights and measuring devices (viz. reference weights, thermometers load cell balance and other measuring gauges) shall be calibrated by external laboratory having National Traceable Reference e.g. NPL (National Physical Lab) and NABL (National Accredition Board for Testing and Calibration) for calibrated weights and measuring devices.
6.3.2 The calibration shall be done with respect to operating range of In House calibration.
6.3.3 Such external laboratory shall issue the calibration certificate for each calibrated device. On receipt of any calibration certificate, QA personnel will review the report for accuracy and correctness for acceptability of the data
6.3.4 If the report doesn’t comply as per the defined acceptance criteria, further corrective action shall be taken accordingly.
6.3.5 Calibration of measuring devices of critical areas shall be calibrated after one year.
6.3.6 Calibration of all the equipments/instruments/measuring devices, weights shall be valid as per calibration schedule and as the date of calibration specified on the calibration certificate. The period of re-calibration is based on handling frequency & storage of these devices. The period is irrespective of the next calibration due mentioned on certificate.
6.3.7 If such calibration could not be arranged in time, the recalibration of the same will be done within a period of next 1 month. During this extended period, calibration of weight and measuring devices is considered valid.
6.3.8 Whenever, weights and measuring devices are sent for calibration, the procedure adopted is as follows:
6.3.8.1 Daily calibration of balance is carried out only for self – verification. If balance is not in use, self calibration on daily basis shall not be done. During this period, shifting of balances to other place of work is not allowed.
6.3.8.2 If master thermometers are send for calibration, during the period, internally calibrated thermometers will be used for calibration of another thermometers (if required).
6.3.8.3 Data in various instruments shall be recorded as per the data recording system programmed by instrument / equipment manufacturer.
6.3.8.4 During breakdown or malfunctioning the particular instrument is identified by a label stating as “UNDER MAINTENANCE” Format No.
6.3.9 If the equipment is not having recording devices, the readings / observations shall be recorded from display and data shall be checked online by second person for its correctness in record.
6.3.10 When any equipment is out of order:
• The concerned service engineer shall be informed.
• A standby arrangement shall be made if available
• If the standby arrangement is available, the same may be used after calibration.
• If standby arrangement is not available, samples shall be sent to other department / external approved laboratory.
6.3.11 For routine servicing and maintenance, either annual service contract or service arrangement is made with instrument’s manufacturer / authorized service agent. Frequency of servicing shall be followed as per the contract.
6.4 Handling of Standard Calibrated Weights :
6.4.1 On receipt of calibrated standard weights, it shall be kept in respective specified area.
6.4.2 The analytical standard weight box up to 200gm is kept properly in secured place. These are maintained in original box.
6.4.3 All the another standard weights are stored in plastic / stainless steel box.
6.4.4 All standard calibrated weights (cast iron) used in stores & production department are kept on pallets / trolley. These weights are covered with polybags so as to prevent due contamination. Specified box on calibration certificate, including date of calibration and due date of calibration shall be displayed either on or on the box.
6.4.5 Handling of analytical weights (up to 200g) shall carefully using specified forceps to be done by using plastic tip forceps.

Annexure No.	Title of Annexure
Annexure-I	Calibration Master Schedule
Annexure-II	Calibration Status Tag