STANDARD OPERATING PROCEDURE - University of Malta · university of malta faculty of medicine &...

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

of 16

Table of Contents

Page

1. Scope 2

2. Objective 2

3. Definitions 2

4. Responsibility 2

5. Procedure 2

6. Precautions 10

7. References 10

8. Appendices 10

9. Revision History 10

Original

Authorised Copy

for:

Reading Copy

Written by: Sign/Date:

Reviewed by: Sign/Date:

Approved by: Sign/Date:

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

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 Issue an Entry Logbook for each laboratory to document the details of the

persons entering into each laboratory.

5.1.2 Issue a Temperature Logbook for each refrigerator present in each

laboratory to document the daily temperature of the room and of the

refrigerator/freezer.

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

5.1.3 Issue a Consumables Logbook for each laboratory to document the use of

consumables.

5.1.4 Issue an On-Loan Equipment Logbook to record the equipment that will be

on-loan.

5.1.5 Issue an Equipment Logbook for each medical device and equipment to

document the activities that are carried out on each.

5.1.5 Use a bound book to avoid having loose sheets of paper.

5.1.6 Number the logbook pages prior to use.

5.1.7 Include an official label (Appendix SOP/PD/105_02/A1) on the front

cover of the logbook (Refer to Section 5.2).

5.1.8 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 Name

5.6.1.2 Course year

5.6.1.3 Activity

5.6.1.4 Date

5.6.1.5 Name of Demonstrator

5.6.1.6 Signature

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

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 Place the temperature logbook next to the refrigerator/freezer or

designated area.

5.5 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

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

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 Place the equipment logbook adjacent to the equipment or designated

area.

5.8 Using the Logbook

5.8.1 Record in ink directly into the logbook.

5.8.2 Cross out any errors ensuring that the mistake is still legible. Sign, date

and annotate the correction.

5.8.3 Do not remove any pages from the logbooks.

5.9 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).

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

5.10 Flow Chart

5.10.1 Issuing a Logbook

Start

Divide each page with these headers:

Name, Course Year, Activity, Date,

Name of Demonstrator, Signature

Divide each page with these headers: Name, Time, Refrigerator T, Freezer

T, Room T and signature

Number each page

Use bound books for logbooks

Issue logbook and place in close

vicinity to door

Include Official Label on front cover

Include Lab Officer signature and

total number of pages on official

label

Number each page


1

Issue logbook and place next to

refrigerator/freezer or designated area

Need to issue Entry

Logbook

Need to issue

Temperature logbook

Include Lab Officer signature and total number of pages on official

label

Need to issue

Consumables logbook

Divide each page with these headers: Name of Consumable, Name of User,

Course Year, Date out, Signature,

Date in and Signature

Number each page



label

Issue logbook

Need to issue On-Loan Equipment

logbook

2

Yes

Yes Yes Yes

No

No No No

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

1

2

Divide each page with these headers: Inventory No/Name of Equipment,

Course Year, Date out, Signature,

Date in and Signature

Number each page



label

Issue logbook

Need to issue an

Equipment logbook

Divide each page with these headers:

Name, Course Year, Activity, Date

and Signature

Number each page



label

Issue logbook and place adjacent to

equipment or designated area

End

No

Yes

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

5.10.2 Using a Logbook

Start

Record in ink directly into logbook

Made a mistake in

entry

Cross out but leave mistake still legible. Sign, date and annotate

correction

Do not remove any pages from

logbook

End

Yes

No

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

5.10.3 Logbook Upkeep

Start

Logbook being

correctly filled in by users

Logbook completed

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)

Train users on the proper filling

procedure of logbook

End

No

No

Yes

Yes

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

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 Amendments/ Reasons for change

01 Initial Release

02 Change in Scope

Included definition of Activity

Included On-Loan Equipment Logbook

Included flow charts

Included Laboratory Logbooks Database

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

SOP/PD/105_02/A1 – Laboratory Logbooks Labels

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

EQUIPMENT LOGBOOK

Inventory Number:

Name of Equipment:

Date of Issue: __ __/__ __ /__ __ __ __

Laboratory Officer Signature: _________________

Total Number of Pages:

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

TEMPERATURE LOGBOOK

Date of Issue: __ __/__ __ /__ __ __ __



UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

CONSUMABLES LOGBOOK

Date of Issue: __ __/__ __ /__ __ __ __



UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

ENTRY LOGBOOK

Date of Issue: __ __/__ __ /__ __ __ __



UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

ON-LOAN EQUIPMENT LOGBOOK

Date of Issue: __ __/__ __ /__ __ __ __



UNIVERSITY OF MALTA


PHARMACY DEPARTMENT

Ref. No.

SOP/PD/105_02




of 16

SOP/PD/105_02/A3 – Laboratory Logbooks Database

Name Location Date of issue Review Date Review Date

Review Date

STANDARD OPERATING PROCEDURE - University of Malta · university of malta faculty of medicine &...

Documents

Transcript of STANDARD OPERATING PROCEDURE - University of Malta · university of malta faculty of medicine &...