Usage Of Instrument/Equipment Log Book

 

1.0              OBJECTIVE:

To lay down the procedure for describe maintaining machine, Instrument / Equipment use log.

2.0              SCOPE:

This SOP is applicable to all machine Instruments/Equipments maintaining use log book at --------------------------------------------------

3.0              RESPONSIBILITY:

The responsibility for entries in the Instrument/equipment log books lies with all department Officer/Designee and Heads.

4.0              ACCOUNTABILITY:                       

The Accountability for implementation and complies of this SOP lies concerned department heads and Quality Assurance Head.

5.0              PROCEDURE:

5.1              The equipment / instrument log book shall be maintained for all equipments and instruments.

5.2              The master format of equipment / instrument log book shall be controlled by QA

5.3              QA shall issue the control copy of the equipment / instrument log book/ formats to the concerned department as per SOP on issue and control of formats.

5.4              The concerned department shall use the issued copy of the equipment / instrument log book/ formats for entering all the details of activities being carried out.

5.5              Write activities carried out for particular equipment in the logbook assigned for that equipment in format on daily basis.

5.6              Equipment Log book

5.6.1        In equipment log book, the start time shall be entered immediately after the machine starts by the operator.

5.6.2        The end time shall be entered immediately after the end of the operation.

5.6.3        If machine stops due to some maintenance reason then the breakdown time shall be entered in respective column

5.6.4        The reason for the breakdown shall be written in remarks.

5.6.5        The cleaning time shall be entered whenever the equipment is cleaned.

5.6.6        For equipments, all the entries shall be done as per Format No.: F/QA-015-01

5.6.7        At the end of the operation the officer or above of concern department shall verify the activity and sign in ’checked by’ column.

5.6.8        Equipment cleaning (Type A or B) carried out after every operation maintenance (breakdown) etc.

5.6.9        Maintenance (breakdown) work carried out then equipment cleaning carried out.

5.6.10    Every activity entered shall be signed by Officer/Designee.

5.7              Instrument Log Book

5.7.1        In case of instrument, the analyst shall enter all details as per Format No.: F/QA-015-02

5.7.2        In case if there is any breakdown, the breakdown time shall be entered in ’end time’ column.

5.7.3        The reason for breakdown shall be mentioned in remarks column.

5.7.4        At the time of restart after lunch break, tea break or after maintenance or breakdown new entry shall be done from the starting in next row.

5.8              These log books will be preserved for the period of ten years for further reference.

5.9              Entry of Instrument/Equipment constitutes an essential part of cGMP and Quality Assurance system.

5.10          All logbooks entry to permits tracing of Instrument/Equipment history and provides proper information in case of any investigation.

5.11          Enter the occupy timing (begin to end) of Instrument / Equipment in the log book at time of uses start and end the uses.

5.12          All departments shall ensure that log book is available for each and every instrument / equipment used in the department.

5.13          Log books shall be issued from Quality Assurance department based on the requisition given by the respective department.

5.14          Department Officer/executive shall ensure that the log books are entered / filled On Line. When ever any instrument/equipment is started, details shall be recorded in the respective log book Format No.: F/QA-015-01.

            5.7       Any break down of the machine shall be recorded in the Remarks column and the time for maintenance carried out shall also be recorded.

            5.8       All log books shall be recorded as per the SOP for Good Documentation Practices (SOP-QA-014)

            5.9       If any log book is finished, separate requisition is given to Quality Assurance for issuance and the old book is filled completely and returned to Quality Assurance before issuance of new book.

            5.10     “CONTROLLED COPY” stamp only on the first page of the log book with proper colour ink & with the declaration of page contains in the log book and to which department to be issued.

            5.11     Acceptance Criteria: All Logs should be maintained at the time of Instrument/Equipment uses.

            5.12     Frequency: Whenever required.

Note:

¨          One log book shall be dedicated for one instrument / equipment only

¨          All entries shall be done online.           

¨          Not more than one entry is allowed in one row.

 

6.0              LIST OF ANNEXURE / FORMATS:           

Sr. No.	Title of Format	Format No.
	Equipment log book	F/QA-015-01
	Instrument log book	F/QA-015-02
	INSTRUMENT / EQUIPMENT Clean Label	F/QA-015-03

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

 

8.0              REVISION HISTORY:  

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

 

9.0              ABBREVIATIONS:

Sr. No	Abbreviations	Details
01	SOP	Standard Operating Procedure
02	QA	Quality Assurance

 

 

 

 

 

 

END OF DOCUMENT

EQUIPMENT NAME:	EQUIPMENT ID NO. :
DEPARTMENT:	SECTION:

 

Date

Name of Product

Batch No.

Operation

Carried out by

Type of Cleaning (A / B)

Cleaning

Carried Out by

Maintenance

Carried  out  by

Checked by

Remarks

From

To

From

To

From

To

 

INSTRUMENT NAME:	INSTRUMENT ID NO. :
DEPARTMENT:	SECTION:

 

Date	Sample Name	Batch. No.	Test Performed	Start Time	End Time	Cleaning		Operated By	Checked By	Remarks
						From	To