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1.0. OBJECTIVE:
The objective of this SOP is to ensure that the instrument performs satisfactorily and
gives accurate and reproducible data.
2.0. RESPONSIBILITY:
2.1 The Chemist/ Executive - Quality Control shall be:
2.1.1. Responsible for operating the HPLC as per the SOP.
2.1.2. Responsible for timely calibration of HPLC System as per the SOP.
2.1.3 Responsible for ensuring the adherence of SOP.
3.0. ACCOUNTABILITY:
Head - Quality Control
4.0. PROCEDURE:
4.1 PROCEDURE FOR GENERAL CLEANING:
4.1.1 Ensure that the power supply to the instrument is switched off and main
cord is removed from supply.
4.1.2 Clean the instrument with a clean dry cloth every day. A wet cloth dipped in
dilute soap solution may be used occasionally.
4.1.3 Precaution must be taken to clean the instrument immediately with dry
cloth.
4.7.8.1 Detector: Once in three months and after each maintenance job.
4.7.8.2 Pump: Once in three months and after each maintenance job.
4.7.8.3 Injector: Once in six months and after each maintenance job.
4.7.8.4 Gradient: Once in six months and after each maintenance job in the
pump.
5.0 TRAINING:
Trainer -- Head – Quality Control
Trainees -- Quality Control Chemists and Assistants
Period -- One day
6.0 DISTRIBUTION:
Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : File copy in HPLC Calibration Data
Reference Copy No. 3 : Display copy Near HPLC System
Original Copy : Head – QUALITY ASSURANCE.
7.0 ANNEXURES:
Annexure – 1 : Format for Calibration Record of Pump (Flow Rate)
Annexure – 2 : Format for Calibration Record of Gradient Proportionate Valve
Annexure – 3 : Format for Calibration Record of Injector
Annexure – 4 : Format for Calibration Record of Detector
8.0 REFERENCES:
In house.
ANNEXURE – 1
FORMAT FOR CALIBRATION RECORD OF HPLC
Revision No.: 00
REF. SOP NO.: Page No.: 1 of 1
Effective from: