SOP Title: Management of Laboratory Instruments
- Objective:
To lay down the procedure for management of laboratory instruments.
- Scope:
This procedure is applicable for management of laboratory instruments in the Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for management of laboratory instruments in Quality Control Department as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department.
- Procedure
| 5.1 | Installation and Qualification of Instrument and Equipment : | |
| 5.1.1 | For all new instrument and equipment received in the laboratory allocate an identification number. | |
| 5.1.2 | Get the instrument and equipment installed and qualified as per individual installation and qualification protocols, which is either provided by manufacturer/service provider or prepared in house and approved. | |
| 5.1.3 | Prepare operating procedure including calibration parameters and performance verification parameters along with acceptance criteria and frequency schedule based on pharmacopoeia, regulatory guidelines and instrument manufacture/ service provider’s guidelines etc. | |
| 5.1.4 | Perform complete calibration/ performance verification as mentioned in relevant instrument/ equipment SOP. In case parameter are listed under multiple schedules, then perform all parameters listed under all schedule/ frequency. | |
| 5.1.5 | While using the instrument, usage entry shall be done in instrument usages logbook/ log sheet. | |
| 5.1.6 | Incorporate the instrument/ equipment in master plan for performance verification and get the same also included in the master maintenance schedule available with the maintenance department, if applicable. | |
- Definitions / Abbreviations:
- Definitions :
- Abbreviations:
| Abbreviation | Expansion |
| QC | Quality Control |
| QA | Quality Assurance |
| SOP | Standard Operating Procedure |
| i.e. | That is |
*Note – Ready to use SOP available in “DOWNLOAD” Section.