sop

Instrument calibration Purpose:

Instrument calibration, This SOP ensures that all type laboratory instruments of QC, PD, IPQC, Microbiology and balances of Production department are appropriately calibrated and calibration status maintained on due time.

Scope :

This procedure is applicable for calibration frequency of all types of laboratory instruments installed in QC, PD, IPQC, Microbiology and balances of Production department of General Block of XX Pharmaceuticals Ltd.

Definitions :

[][]QC: Quality Control.
[][]ENG: Engineering department.
[][]PD: Product development.
[][]IPQC: In-process Quality Control.

Responsibilities:

The roles and responsibility is as follows:

Officer/ Executive

[][]Ensure that the instructions of this procedure are correctly followed.
[][]Ensure that all equipment’s are included in the Instrument list.
[][]Maintain and track the calibration schedule.
[][]Ensure that all equipment’s bear appropriate calibration label and are used after calibration.
[][]To verify the third party calibration report and raw data.

Manager, Quality Control

[][]Ensure that this procedure is kept up to date.
[][]Ensure that the calibration requirement are assessed and are fully documented for all pieces of the instrument.
[][]Ensure appropriate personnel from the section are trained on this procedure.
[][]Confirm that SOP is technically sound and reflects the required working practices.

Manager, Quality Assurance

[][]Approval of SOP.
[][]Approval of calibration frequency and calibration schedule.

Precaution(s):

[][]There are no significant hazards or special instructions relating to the process/activities described in this SOP.

Procedure:

[][]Calibrate the equipment regularly as per frequency stated in the instrument calibration frequency (prepared as per format in Annexure-I) and as per calibration due date stated in the instrument calibration schedule (prepared as per format in Annexure-II) for individual equipment.
[][]Review the instrument calibration frequency when new instrument is included.
[][]Review the instrument calibration schedule yearly.
[][]Mention the responsibility (Third Party / Supplier name) for external calibration and (calibrator name and department) for internal calibration.
[][]Calibrate the instrument within 3 days of calibration due for monthly calibration period, within 7 days of calibration due for 3 and 6 monthly calibration period and 15 days of calibration due for yearly calibration period.
[][]In case of any breakdown or replacement of any damaged part where calibration needs to be carried out, the calibration schedule will be reviewed accordingly.
[][]Executive/ Sr. Executive of respective department will intimate the Engineering department/ Supplier service engineer/ outside agencies for the calibration of the instruments/ equipments.
[][]Maintain all standards, reagents, instruments and equipments etc. required for calibration.
[][]Calibrate the instrument across the operating range at a frequency appropriate to the reliability and frequency of use. Tolerance must be specified and should reflect the manufacturer’s specification or process tolerance or whichever the tightest.
[][]Re-evaluate calibration requirement immediately if there is any change in the instrument in use.
[][]Calibration must be performed by trained personnel or by approved Third Party Service Engineer.
[][]Calibration record must include:
=>Equipment name, model number and instrument ID No.
=>The name of the person who carried out the calibration.
=>Date of calibration.
=>The date when calibration is next due.
[][]For calibration, use reference standards or reference instruments whose calibration is traceable.
[][]Store the calibration device, certified standard weight in a secure place.
[][]For internal calibration, affix the calibration sticker label “ CALIBRATED” (format of calibration labels should be as per SOP: Calibration management program, Ref. No. SOP/ENG/00Y/XX, where XX refers to current version no.), with performer initial, date of completion and calibration due.
[][]For external calibration, affix the calibration sticker provided by external calibrator with performer’s initial, date of completion and calibration due.
[][]If the instrument is found out of tolerance/ limit during calibration, a label ‘Out of calibration” will be affixed on the instrument (as per SOP: Calibration management program No. SOP/ENG/00Y/XX, where XX refers to current version no.).

Notify the relevant person/ department/ organization to repair (or replace if necessary) the instrument in a timely manner.

Download

Annexure I Instrument Calibration Frequency
Annexure II Instrument Calibration Schedule