SOP on maintaining Quality Control equipment / instrument log book
Objective :
- To lay down the procedure for maintaining equipment / instrument log book in Quality Control Department.
Scope:
- This procedure is applicable for maintaning equipment / instrument log book in Quality Control Department .
Responsibility:
Chemist or above of QC department
Accountability:
Head Quality Control
Procedure:
- The equipment / instrument log book shall be maintained for all equipments / instruments used in Quality Control department.
- The master format of equipment/ instrument log book shall be controlled by Quality Assurance department.
- The QA department shall issue the control copy of instrument log book.
- In instrument log book, analyst shall enter the start time just after analyst starts work on respective instrument.
- The end time shall be entered immediately at the end of operation.
- If instrument is not working properly then record observation in Instrument Breakdown History Record as per Annexure No. A03 and affix “OUT OF ORDER” label as per Annexure No. A03 and follow for further action.
- HPLC/GC instrument log book shall be as per Annexure No. A01 and instrument log book of rest of the instruments shall be as per Annexure No. A02 .
Note : All entries shall be done online. Not more than one entries are allowed in one row.
List of Annexure / Formats:
| S.
No. |
Format Title | Annexure
Number |
| 1 | Instrument Log Book (HPLC / GC) | A01 |
| 2. | Instrument log book (General) | A02 |
| 3. | Instrument Breakdown History Record | A03 |
References (if any):
Reason for Revision:
Not applicable due to first version.
Abbreviation:
- QC : Quality Control
- QA : Quality Assurance
- SG : Sub-General
- SP : Specific
For Other Pharma Related Post and Updates Click Here
Quality Control Department
Instrument Log Book (HPLC /GC)
Name of Instrument : Instrument ID. No.:
| Sr. No. | Date | Sample Name | Batch No. | Test Performed | Column ID. No. | Start Time | End Time | No. of Injections | Used By | Checked By | Remarks |
Quality Control Department
Instrument Log Book (General)
Name of Instrument : Instrument ID. No.:
| Sr. No. | Date | Sample Name | Batch No. | Test Performed | Start Time | End Time | Used By | Checked By | Remarks |
Quality Control Department
Instrument Breakdown History Record
Name of Instrument : Instrument ID. No.:
| Sr. No. | Date | Problem Occurred | Verified By | Action Taken | Problem Rectified on | Rectified By | Verified By | Remarks |