sop for calibration procedure of instruments

 

sop for calibration procedure of instruments

1.0 OBJECTIVE 
1.1 To describe a procedure for to define Calibration program of Quality Control Instruments as per specified frequency.
2.0 SCOPE
2.1 This procedure is applicable for to Calibration program the Quality control department
3.0 RESPONSIBILITY
3.1 Officer /Executive – QC
4.0 ACCOUNTABILITY

4.1 Head – QC
5.0 PROCEDURE

5.1 Calibration of QC instruments falls in two categories.

5.2 Internal calibration: Such calibration is carried out by using standards available in laboratory.

5.3 External calibration: Such calibration is carried out by third party (Third party may take instrument outside premises).

5.4 Prepare year wise calibration schedule as per Format This is to be prepared in last week of the Year for next year and so on.

5.5 Calibration to be carried out as per following frequencies.

Sr. No. Calibration Frequency Tolerance
1.0 Daily N.A.
2.0 Monthly ± 2 Days
3.0 Quarterly ± 7 Days
4.0 Half Yearly ± 15 Days
5.0 Yearly ± 20 Days

5.6 Before starting calibration, check availability and validity of the required standards.

5.7 Ensure that all standard chemicals meet requirement of respective pharmacopoeia and use only qualified instruments (if required) for calibration.

5.8 Issue the calibration protocol sign with ref. no and issued date.

5.9 Before starting calibration go through respective procedure and protocol. In case of any discrepancy, contact

Executive / Manager.

5.10 Perform the calibration of instrument & check as per specified procedure.

5.11 After completion of respective check, write down status of instrument on calibration card and sign it as per

Format

5.12 In case of results are not found satisfactory, immediately inform to Executive & above of QC Department.

5.13 Write down all observations/ results in respective protocol and take approval of authorized person.

5.14 Before approval of record, authorized person will check all the calculation and ensure that calibration is carried out as per standard procedure and results are satisfactory with in specified limits.

 

5.15 If calibration of instrument does not found satisfactory and error is not identified, label the instrument as ‘Out

of Calibration’.

5.16 Prepare month wise daily verification schedule as per Format

 

6.0 REFERENCE

6.1 In House

7.0 FORMATS
Instrument Calibration Schedule Quality Control

Calibration Format

Daily Verification Schedule
Instrument Calibration Schedule (Micro)

Instrument Calibration Schedule Outside

8.0 ABBREVIATIONS
8.1 QC Quality Control
8.2 QA Quality Assurance
8.3 QCA Quality Control Analytical
8.4 SOP Standard Operating Procedure

 

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Cleaning of Instrument, Instrument bench and surrounding area of Quality

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Operation and Cleaning of Centrifuge Apparatus

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Calibration of Fourier Transform Infrared Spectrophotometer (FTIR)

Cleaning and operation of Moisture Analyzer

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Operation and Calibration of Polarimeter

Cleaning and operation of Magnetic Stirrer

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Entry and Exit in Quality Control Department

 

 

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