UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
Table of Contents
Page
1.
2.
3.
4.
5.
6.
7.
8.
9.
Scope
Objective
Definitions
Responsibility
Procedure
Precautions
References
Appendices
Revision History
2
2
2
2
2
10
10
10
10
Original
Authorised Copy
for:
Reading Copy
Written by:
Sign/Date:
Reviewed by:
Sign/Date:
Approved by:
Sign/Date:
Page 1 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
1. Scope
This Standard Operating Procedure (SOP) applies to the staff and students of the
Pharmacy Department, University of Malta involved in the issue, use or upkeep of the
laboratory logbooks.
2. Objective
To describe the layout, issue, distribution, use and upkeep of the laboratory logbooks.
3. Definitions
3.1 Activity: Use, calibration, maintenance or cleaning procedures that are performed
on/with the equipment.
3.2 Logbook: A bound book used to record activities carried out in the laboratory or
on an equipment.
4. Responsibility
4.1 The designated Laboratory Officer or Laboratory Assistant is responsible for
ensuring that this SOP is followed.
4.2 The designated Laboratory Officer or Laboratory Assistant is responsible for the
upkeep of logbooks.
4.3 The members of the Department of Pharmacy (staff and students) are responsible
for filling in the respective logbooks.
5. Procedure
5.1 Logbook Issue
5.1.1
5.1.2
Issue an Entry Logbook for each laboratory to document the details of the
persons entering into each laboratory.
Issue a Temperature Logbook for each refrigerator present in each
laboratory to document the daily temperature of the room and of the
refrigerator/freezer.
Page 2 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
5.1.3
5.1.4
5.1.5
5.1.5
5.1.6
5.1.7
5.1.8
Issue a Consumables Logbook for each laboratory to document the use of
consumables.
Issue an On-Loan Equipment Logbook to record the equipment that will be
on-loan.
Issue an Equipment Logbook for each medical device and equipment to
document the activities that are carried out on each.
Use a bound book to avoid having loose sheets of paper.
Number the logbook pages prior to use.
Include an official label (Appendix SOP/PD/105_02/A1) on the front
cover of the logbook (Refer to Section 5.2).
Write the headings of the columns to be used on each page of the logbook.
5.2 Official Label
5.2.1
Include the following components in the official label:
5.2.1.1 Department of Pharmacy logo
5.2.1.2 Name of the University
5.2.1.3 Name of the Faculty
5.2.1.4 Name of the Department
5.2.1.5 Name of logbook (eg. Entry Logbook)
5.2.1.6 Inventory number or Serial number (if applicable)
5.2.1.7 Name of equipment (if applicable)
5.2.1.8 Date of issue
5.2.1.9 Signature of Laboratory officer
5.2.1.10 Total number of pages
5.3
Entry Logbook
5.3.1
Divide the pages of the entry logbook into columns with the following
headers:
5.6.1.1
5.6.1.2
5.6.1.3
5.6.1.4
5.6.1.5
5.6.1.6
Name
Course year
Activity
Date
Name of Demonstrator
Signature
Page 3 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
5.3.2
Place the entry logbook in close vicinity of the door.
5.4 Temperature Logbook
5.4.1
Divide the pages of the Temperature Logbook into columns with the
following headers:
5.4.1.1 Date
5.4.1.2 Time
5.4.1.3 Refrigerator Temperature (if applicable)
5.4.1.4 Freezer Temperature (if applicable)
5.4.1.5 Room Temperature
5.4.1.6 Signature
5.4.2
5.5
Place the temperature logbook next to the refrigerator/freezer or
designated area.
Consumables Logbook
5.5.1
Divide the pages of the Consumables Logbook into columns with the
following headers:
5.5.1.1 Name of Consumable
5.5.1.2 Name of user
5.5.1.3 Course Year (if applicable)
5.5.1.4 Date Out
5.5.1.5 Signature
5.5.1.6 Date In
5.5.1.7 Signature
5.6
On-Loan Equipment Logbook
5.6.1
Divide the pages of the On-Loan Equipment logbook into columns with
the following headers:
5.6.1.1 Inventory number / Name of equipment
5.6.1.2 Name of user
Page 4 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
5.6.1.3 Course year
5.6.1.4 Date out
5.6.1.5 Signature
5.6.1.6 Date in
5.6.1.7 Signature
5.7
Equipment Logbook
5.7.1
Divide the pages of the Equipment Logbook into columns with the
following headers:
5.3.2.1 Name
5.3.2.2 Course Year (if applicable)
5.3.2.3 Activity
5.3.2.4 Date
5.3.2.5 Signature
5.7.2
5.8
Using the Logbook
5.8.1
5.8.2
5.8.3
5.9
Place the equipment logbook adjacent to the equipment or designated
area.
Record in ink directly into the logbook.
Cross out any errors ensuring that the mistake is still legible. Sign, date
and annotate the correction.
Do not remove any pages from the logbooks.
Logbook Upkeep
5.9.1
Ensure that logbooks are being correctly filled in by users whenever an
activity is carried out.
5.9.2 Ensure that new logbooks are issued to replace completed ones. Archive
completed logbooks.
5.9.3 Review the logbooks every 6 months. Sign and date this on the logbook
with an appropriate entry.
5.9.4 Enter each logbook review date into the ‘Laboratory Logbooks Database’
(SOP/PD/105_02/A2).
Page 5 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years
LABORATORY LOGBOOKS
from approval
5.10 Flow Chart
5.10.1 Issuing a Logbook
Start
Use bound books for logbooks
No
Need to issue
Temperature
logbook
Need to issue Entry
Logbook
Yes
Yes
Divide each page with these headers:
Name, Course Year, Activity, Date,
Name of Demonstrator, Signature
Number each page
No
Need to issue
Consumables
logbook
No
Yes
Divide each page with these headers:
Name, Time, Refrigerator T, Freezer
T, Room T and signature
Divide each page with these headers:
Name of Consumable, Name of User,
Course Year, Date out, Signature,
Date in and Signature
Number each page
Number each page
Include Official Label on front cover
Include Official Label on front cover
Include Official Label on front cover
Include Lab Officer signature and
total number of pages on official
label
Issue logbook and place in close
vicinity to door
Include Lab Officer signature and
total number of pages on official
label
Issue logbook and place next to
refrigerator/freezer or designated area
Include Lab Officer signature and
total number of pages on official
label
Issue logbook
No
Need to issue OnLoan Equipment
logbook
Yes
1
Page 6 of 16
2
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
1
Divide each page with these headers:
Inventory No/Name of Equipment,
Course Year, Date out, Signature,
Date in and Signature
Number each page
Include Official Label on front cover
Include Lab Officer signature and
total number of pages on official
label
Issue logbook
No
Need to issue an
Equipment logbook
2
Yes
Divide each page with these headers:
Name, Course Year, Activity, Date
and Signature
Number each page
Include Official Label on front cover
Include Lab Officer signature and
total number of pages on official
label
Issue logbook and place adjacent to
equipment or designated area
End
Page 7 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
5.10.2 Using a Logbook
Start
Record in ink directly into logbook
No
Made a mistake in
entry
Yes
Cross out but leave mistake still
legible. Sign, date and annotate
correction
Do not remove any pages from
logbook
End
Page 8 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
5.10.3 Logbook Upkeep
Start
No
Logbook being
correctly filled in by
users
Train users on the proper filling
procedure of logbook
Yes
No
Logbook completed
Yes
Issue new logbook to replace
completed one
Archive completed logbook
Review logbook every 6 months and
sign and date logbook with an
appropriate entry
Enter logbook review date into the
Laboratory Logbooks Database
(Appendix 2)
End
Page 9 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
6. Precautions
Not Applicable
7. References
Not Applicable
8. Appendices
SOP/PD/105_02/A1 – Laboratory Logbooks Labels
SOP/PD/105_02/A2 – Laboratory Logbooks Database
9. Revision History
Version Number
01
02
Amendments/ Reasons for change
Initial Release
Change in Scope
Included definition of Activity
Included On-Loan Equipment Logbook
Included flow charts
Included Laboratory Logbooks Database
Page 10 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
SOP/PD/105_02/A1 – Laboratory Logbooks Labels
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
EQUIPMENT LOGBOOK
Inventory Number:
Name of Equipment:
Date of Issue: __ __/__ __ /__ __ __ __
Laboratory Officer Signature: _________________
Total Number of Pages:
Page 11 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
TEMPERATURE LOGBOOK
Date of Issue: __ __/__ __ /__ __ __ __
Laboratory Officer Signature: _________________
Total Number of Pages:
Page 12 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
CONSUMABLES LOGBOOK
Date of Issue: __ __/__ __ /__ __ __ __
Laboratory Officer Signature: _________________
Total Number of Pages:
Page 13 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
ENTRY LOGBOOK
Date of Issue: __ __/__ __ /__ __ __ __
Laboratory Officer Signature: _________________
Total Number of Pages:
Page 14 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
ON-LOAN EQUIPMENT LOGBOOK
Date of Issue: __ __/__ __ /__ __ __ __
Laboratory Officer Signature: _________________
Total Number of Pages:
Page 15 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/105_02
STANDARD OPERATING PROCEDURE
LABORATORY LOGBOOKS
Valid for:
2 years
from approval
SOP/PD/105_02/A3 – Laboratory Logbooks Database
Name
Location
Date of issue
Review Date
Page 16 of 16
Review Date
Review Date