International Journal of Science and Research (IJSR)

ISSN (Online): 2319-7064

Index Copernicus Value (2015): 78.96 | Impact Factor (2015): 6.391

Implementing of Good Laboratory Practice (GLP)

in Food Analysis Laboratories of Baghdad
University
Mahmud Abdullah Jasim Alkhafaji
Market Research and Consumer Protection Center / University of Baghdad

Abstract: In line with the instructions of the Department of Quality Assurance and Academic Accreditation at the University of
Baghdad in implementing good laboratory practice in the University laboratories, this study was performed to show the competency of
(21) scientific laboratories related with food analysis in implementing of the requirements of GLP. Results show differential weights
between 14 to 89% depending of various factors such as lab infrastructures, facilities, and the activities of lab personals in implementing
of GLP.

Keywords: GLP, University, laboratories.

1. Introduction For implementing GLP in food analysis laboratories at

Baghdad University, it should be implemented GLP
Good Laboratory Practice identifies GLP is a quality regulation by the laboratory. Accordance to the instructions
system concerned with the organizational process and the of the Department of Quality Assurance at Baghdad
conditions, under which non-clinical health and University, all laboratories should fulfill GLP requirements in
environmental safety studies are planned, performed, certain time starting from 2016. This matter was studied by
monitored, recorded, archived and reported (1). It not only each lab and it planned to implement (4).
defines GLP as a quality system, but it also separate it
against other quality systems by confining it to the 2. Materials and Methods
organizational process and the conditions under which the
whole process of a non-clinical health and environmental To implement GLP in the laboratories of the University of
safety study has to be developed, from its inception and Baghdad, a revision of GLP references performed and
design till its final stage of reporting and archiving. attending to workshops organized by the department of
quality assurance at the University of Baghdad has been done
The aim of GLP principles is to promote the development for discussing how we can implement the requirements of
of quality test data; there is a Quality Assurance program GLP. Questionnaire has been prepared and submitted to (21)
that the quality assurance responsibility is being performed laboratories related with food analysis in different faculties at
in compliance with of GLP principles (2). In addition to the University of Baghdad, to show the actual situation of the
that, comparable quality of test data forms is the basis for laboratory and what is the percentage can the surveyed
the mutual acceptance of data among countries and the laboratory obtain. The questionnaire contains the 10 clauses
measure certainly applies to the development and of GLP and the requirements of each clause, and it is given as
improvement of educational laboratories in scientific questions that should be answered by the lab responsible. The
universities. percentage of the requirement of GLP implemented by each
lab calculates in accordance to the data weight below:
The benefits of implementing GLP in the laboratories of
the University is to: Improve the level of educational Data Weight:
laboratories, Increase the confidence in the test and Number of clauses = 10
measurement results, increase the confidence of the Number of requirements = 69
educational institution administration in the quality of the Value of each requirement of 100% weight = 1.4
educational performance of their product, adjust the To calculate the weight of each clause it has been used the
corresponding procedure is not for calibration or testing following:
through the procedural way of corrective action and Number of requirements in the clause × 1.4
preventive action and achieve continuous development and
improvement (3). 2.1 Laboratory Infrastructure

Laboratories which concerns in food analysis at the The laboratory which food analysis performed at Baghdad
University of Baghdad divided between scientific University must be designed in accordance to the services
departments of the colleges of Agriculture, Veterinary, provided by the laboratory and should be meet the
Science, Education and Market Research and Consumer requirements given in the guidance of good Iraqi lab higher
Protection Center (MRCPC) and others related education.
departments.

Volume 6 Issue 2, February 2017

www.ijsr.net
Licensed Under Creative Commons Attribution CC BY
Paper ID: 4021703 DOI: 10.21275/4021703 460
 International Journal of Science and Research (IJSR)
ISSN (Online): 2319-7064
Index Copernicus Value (2015): 78.96 | Impact Factor (2015): 6.391
University laboratory should be designed with sufficient in the laboratory and writing the final report to the top
space suitable with the number of the students in the manager if non-compliance cases founded in the work (7).
laboratory and meet the national standard of GLP
announced by the Iraqi Ministry of Higher Education and 3. Results and Discussion
Scientific Research. Ventilation system and lightning
must have maintenance program according to the degree of Questionnaire has been created in accordance to the criteria
the risk in the laboratory and that should put in a schedule. of Organization for Economic Co-operation and Development
in Testing and calibration for non clinical laboratories (8).
The laboratory should be divided into reception room Questionnaire has been submitted to 21 university
where sample received and the report of test results gives to laboratories related in food analysis. The questionnaire
the customer and test and analysis room and other room if created as questions addressed to the responsible of surveyed
required. The laboratory should be equipped with first aid laboratories and contained the 10 clauses of GLP and its
box and guidance in the case of emergency to treat with requirements. The questions and the answers of all surveyed
chemical, biological, physical, electrical and mechanical laboratories are listed below:
risk (2).
Clause 1: Organization and Personals / Laboratory
2.2 Equipments, Standard Solutions and Reagent Questions Yes No Don’t
know
Include: equipments, standard solutions, laboratory 1. Are the tasks, duties, responsibilities and powers 17 3 1
materials, Calibration, symbolization, storage system, and (i.e.: job description) identified strictly to the
at least it should be apply the following requirements: laboratory staff?
a) All equipment and instruments should be symbolized 2. Is the quality policy put within the role and 15 5 1
and recorded all required data such as (the responsibilities of all employees towards quality
results and customer satisfaction? Should it
manufacturer, year of manufacturing, company name ...
declared in Lab entrances?
etc). 3. Have the Laboratory administration announces 11 8 2
b) Putting a timetable for the calibration of laboratory its pledge front superior management to ensure the
equipment and instruments. quality of training for students? And, is the pledge
c) Equipments and instruments data undergo to a central documented and declared?
program to build a database on a laboratory level (5). 4. Is the laboratory management capable for pledge 7 12 2
d) Laboratory chemical and biological materials stores in to do all the requirements of good laboratory
accordance with the international storage system, and practice in effectiveness?
they are symbolized according to (NEPA) American's 5. Are the ideal and selected scientific practices by 16 2 3
system for protection from fires and accidents. lab management apply according to accurate study?
e) Standard solutions keeps and stores according to the 6. Does the laboratory management limits 16 4 1
principles in quality adjusting through laboratory
conditions of functions and calibration program of the tests, implementation, monitoring, recording and
equipment and within the limited temperatures. archiving?
f) Equipment keeps safety after using and according to the 7. Is the laboratory management put a vision, 18 2 1
instructions of using and maintenance. mission and goals of laboratories with similar goals
g) Standard solutions symbolizes with the date of validity made in accordance with specialty?
(2). 8. Are each of administrative structure, laboratories 11 6 4
representative of quality management and the
2.3 Standard Operating Procedures location of the laboratory in educational system
identified?
The standard operating procedures (SOPs) thus created
included, among others: GLP position descriptions; Clause 2: Quality Assurance Program
document control; internal training; internal inspection; Questions Yes No Don’t
know
study plan elaboration; final report elaboration; and filling
out a master schedule. Additional SOPs for describing
1. Has the Laboratory management plan for self- 7 10 4
assessment and analysis of the results of effects?
technical experimental procedures, equipment use and 2. Has the laboratory placed half-annual plan for 9 10 2
maintenance procedures, and procedures for solution internal auditing of the laboratory procedures
preparation were also created. It should be emphasized that and practices?
for all documents approved, there were training programs 3. Are the laboratory Personals trained strictly to 14 6 1
administered to all professionals who would be utilizing the apply the requirements of quality assurance in
documents (6). the laboratory and all of laboratory practices?
4. Is the laboratory management plays an active 19 2 0
2.4 Establishnig Quality System2 role to monitor the incorrect analytical results
and then put corrective actions, in addition to its
commitment to development and implementing
To implement GLP in one laboratory, it is required from
management system and achieving continuous
the laboratory manager to have a strategy to build quality improvement?
system in the laboratory to manage all the operations done 5. Is the daily work of Laboratory 17 1 3
in the laboratory that meet the requirements of GLP. It is administration systematic and structured to
required to designate quality responsible in each laboratory achieve technical competence in performing
follow up the GLP clauses and to implement these clauses practices, tasks and functions assigned to the

Volume 6 Issue 2, February 2017

www.ijsr.net
Licensed Under Creative Commons Attribution CC BY
Paper ID: 4021703 DOI: 10.21275/4021703 461
 International Journal of Science and Research (IJSR)
ISSN (Online): 2319-7064
Index Copernicus Value (2015): 78.96 | Impact Factor (2015): 6.391
employees? And are the roles and 6. Is the equipment keep safety after using and 18 2 1
responsibilities referred in the quality manual? according to the instructions of using and
6. Is the laboratory administration conduct of 8 9 4 maintenance?
reviewing actions within a half year, for 7. Are the standard solutions symbolizes with the 16 3 2
determining the performance deviations and date of validity?
putting procedures and solutions for developing
and performance improvement of system safety? Clause 5: Testing
Questions Yes No Don’t
Clause 3: Facilities know
Questions Yes No Don’t 1. Is any assessment for testing and analysis 17 3 1
know procedures realized?
1. Are the protection kits for students available 12 8 1 2. Are the conditions of laboratory experiments 15 6 0
in the laboratory? And are the students trained determined accurately?
to use them? 3. Are the laboratory technicians trained 13 6 2
2. Is the laboratory equipped with Life 3 18 0 accurately of the laboratory practice? And, are
protection requirements (ventilation, lighting, they examined of their proficiency performance
grounding ground, fire alarm system, sensors, and documenting results?
self-extinguishing) and according to the 4. Is it takes into account accurate procedures in 16 4 1
characteristics of the laboratory and its risk? each of sampling, symbolizing and procedures for
3. Are the Guidance signs and warning for 8 13 0 taking samples?
laboratory safety placed inside and outside the 5. Do be sure of the cleanliness of the equipments, 17 3 1
laboratory to raise awareness of the risks? instruments, glasses and the concentrations of
4. Is the laboratory equipped with first aid box 9 11 1 solutions, its type and using?
and guidance for using in emergency situations 6. Are the specifications select from time to time 12 6 3
when dealing with chemical, physical, for its impact of quality results?
biological, mechanical or electrical risk? 7. Are the test methods and alternative test 10 7 4
5. Is the laboratory designed with sufficient 3 17 1 methods available completely?
space in terms of the number of students and 8. Are the suitable tests methods determine within 9 8 4
the laboratory experiments? And is it designed scientific review reports?
in accordance with the National Standards 9. Do be sure of the validity of standard solutions 18 1 2
stated by the Ministry of Higher Education and and the solutions prepared within specific
Scientific Research-Iraq? concentrations for experiences?
6. Are the laboratory staff trained to use fire 2 17 2
distinguishes according to its characteristics and Clause 6: Test and References
its use?
Questions Yes No Don’t
7. Is there any program used to remove lab 9 12 0 know
containers after each practice? And are the
containers from the closed type?
1. Has the laboratory a clear policy and 16 2 3
procedures for testing or calibration? And, are
8. Is the maintenance program of ventilation 3 17 1 the responsibilities and authorities specified in
systems and lighting applied according to the work management?
degree of laboratory risk? And is any timetable
program used for the maintenance and
2. In the case of non-conforming action, is it 15 1 5
applied to adjust the corrective action,
prevention in the laboratory?
repeating the experience, implementation of
9. Is the laboratory divided into sampling room, 5 16 0 measure evaluation and identifying the
lab analysis room and other room? possible sources in the reasons of non non-
conformity?
Clause 4: Equipments, Standard Solutiones, Reagents And 3. Is the laboratory management implements 9 5 7
Materiales preventive action after each corrective action
Questions Yes No Don’t to prevent potential sources of non-conformity
know occurrence in the future? And, is the
1. Have the instruments and equipment 15 4 2 preventive action available for laboratory
symbolized? And is it recorded all the required employees to raise the level of student
data such as (the manufacturer, year of performance?
manufacture, company name ... etc)? 4. Is the laboratory uses methods and 15 5 1
2. Is there any timetable for calibration laboratory 10 6 5 procedures for all tests / calibrations within
equipment and instruments? the scope of work (sampling, handling,
3. Is the equipment and instrument enters to 6 12 3 transportation, storage and destroyed)?
central program to build a database on a 5. Has the laboratory scientific procedures for 13 8 0
laboratory level? reduction of various risks to students, and in
4. Are the laboratory chemicals and biological 4 12 5 particular: training of lab supervisor and to
materials stores in accordance with the improve the efficiency of their performance?
international storage system? And are the 6. Are the good laboratory facilities include 16 2 3
chemicals and biological materials symbolized (the correct performance of the tests and
according to (NEPA) American's system for calibrations, including sampling, testing and
protection from fires and accidents. calibration) in another places of educational
5. Are the standard solutions keep and stores 15 5 1 institutions?
according to the conditions of functions and 7. Does the laboratory management monitors 13 8 0
calibration program of the equipment and within and controls of the environmental conditions
the limited temperatures? such as (sterilization, dust, gases, radiation,
Volume 6 Issue 2, February 2017
www.ijsr.net
Licensed Under Creative Commons Attribution CC BY
Paper ID: 4021703 DOI: 10.21275/4021703 462
 International Journal of Science and Research (IJSR)
ISSN (Online): 2319-7064
Index Copernicus Value (2015): 78.96 | Impact Factor (2015): 6.391
humidity, heat, noise and vibrations) during a evaluating the performance of the lab activity as
laboratory practices by students as an well as its employees to develop performance
important part of good laboratory practice? evaluating system?

Clause 9: Results Report

Clause 7: Standard Methods Questions Yes No Don’t
Questions Yes No Don’t know
know 1. Has the laboratory suitable procedures to 15 4 2
1. Is the laboratory select and prove 18 2 1 adjust and avoid the error in the results of test,
experimental methods and review them in analysis and calibration through recording of
accordance with the accreditation of good data, operating and results?
laboratory requirements? 2. Does the laboratory management work to 12 6 3
2. Does the laboratory management determines 14 7 0 correct the uncertainly in the results?
the environmental conditions and safety 3. Does the laboratory management analyze the 14 7 0
through the implementation of laboratory data and adjust the documents and perform the
practices for students? correct action into unconformity and
3. Are the methods (operating procedures) easy 19 1 1 unacceptable results?
to apply, transparent and understandable for 4. Does the laboratory treat with results in 13 5 3
students in work steps and the achievement of transparency and clearly according to the
results and goals? instructions of the management of the scientific
4. Are the laboratories practices considered as 17 3 1 organization?
an essential and scientifically part in the study 5. Does the laboratory record the deviations in 12 7 2
program (experimental part) for students? the results or the exceptions and document that
5. Are the standard solutions uses for 16 2 3 and determine the reasons in the method of
calibration of equipment before starting the testing, analysis, sampling and calibration?
laboratory practices by students? 6. Has the laboratory design of results report for 5 11 5
6. Dose the laboratory documents the 15 3 3 each of testing and calibration implemented?
observations and negative indicators through 7. Does the results compare with other 12 4 5
executive action by the students and the practices?
development of preventive and corrective 8. Does the laboratory management perform 6 11 4
actions to prevent their occurrence? correction of the factors affected in the results?

Clause 8: Performance Evaluation Clause 10: Archiving, Recording and Storage oof Reports
Questions Yes No Don’t Questions Yes No Don’t
know know
1. Has the laboratory Placed an annual plan to 11 7 3 1. Does the laboratory management implement 15 5 1
evaluate the performance of employees in procedures to adjust legal, technical and
laboratories? referential documents and each kind of manuals
2. Does the laboratory apply the instructions in 10 6 5 and reports?
the evaluating of performance and in 2. Does the laboratory management implement 7 9 5
equalization of opportunities for Student in the procedures to adjust the seven registers according
laboratory? to GLP?
3. Does the laboratory management looking for 11 6 4 3. Does the laboratory management perform 11 8 2
performance evaluation program as a means to periodical review of documents and to mark the
raise the efficiency of laboratory employees and important one and taking procedures and
supervisors in the good laboratory to give a good solutions for developing and improving?
opportunity for superiority? 4. Does the laboratory management use colored 3 17 1
4. Do the evaluation and study performance 6 8 7 seals to characterize different kind of documents
objectively and fully to build a base of corrective and to achieve quality performance?
actions coinciding with the type and size of the
negative indicators and the obstacles?
5. Has the laboratory specific standards in 6 8 7

To calculate the % weight of each surveyed laboratory in concerns of implementing of the requirements of GLP, it has used
the following, and the results obtained listed in table 1.

% weight = number of requirements in the clause × 1.4

LAB Clause Clause Clause Clause Clause Clause Clause Clause Clause Clause Weight
1 2 3 4 5 6 7 8 9 10 %
1 5.6 2.8 4.2 4.2 5.6 1.4 8.4 0 1.4 2.8 36.4
2 5.6 5.6 2.8 5.6 9.8 8.4 7.0 5.6 8.4 1.4 60.2
3 5.6 4.2 9.8 5.6 9.8 5.6 7.0 4.2 4.2 0 56
4 0 0 1.4 1.4 4.2 4.2 1.4 1.4 0 0 14
5 1.4 1.4 5.6 4.2 2.8 1.4 5.6 2.8 0 0 25.2
6 11.2 8.4 8.4 8.4 12.6 9.8 8.4 7.0 11.2 4.2 89.6
7 5.6 2.8 4.2 5.6 8.4 1.4 8.4 0 2.8 4.2 43.4
8 11.2 2.8 2.8 8.4 8.4 5.6 7.0 1.4 7.0 2.8 57.4
9 5.6 2.8 1.4 1.4 5.6 5.6 4.2 2.8 5.6 2.8 37.8
Volume 6 Issue 2, February 2017
www.ijsr.net
Licensed Under Creative Commons Attribution CC BY
Paper ID: 4021703 DOI: 10.21275/4021703 463
 International Journal of Science and Research (IJSR)
ISSN (Online): 2319-7064
Index Copernicus Value (2015): 78.96 | Impact Factor (2015): 6.391
10 8.4 8.4 1.4 5.6 11.2 8.4 8.4 0 11.2 0 63
11 8.4 5.6 1.4 5.6 9.8 8.4 8.4 0 11.2 0 58.8
12 8.4 7.0 12.6 7.0 9.8 9.8 8.4 5.6 9.8 2.8 81.2
13 8.4 4.2 8.4 5.6 11.2 5.6 7.0 2.8 5.6 0 58.8
14 9.8 7.0 5.6 8.4 12.6 9.8 8.4 5.6 9.8 5.6 82.6
15 11.2 5.6 0 4.2 1.4 5.6 1.4 1.4 5.6 1.4 37.8
16 8.4 8.4 1.4 5.6 9.8 5.6 7.0 1.4 5.6 1.4 54.6
17 11.2 8.4 8.4 7.0 9.8 7.0 7.0 7.0 4.2 1.4 71.4
18 9.8 7.0 5.6 8.4 11.2 8.4 5.6 7.0 1.4 5.6 70
19 9.8 5.6 2.8 7.0 9.8 9.8 8.4 1.4 9.8 4.2 68.6
20 9.8 4.2 2.8 5.6 9.8 8.4 7.0 1.4 5.6 4.2 58.8
21 0 1.4 0 1.4 4.2 2.8 4.2 1.4 4.2 1.4 20.8

Table 1: % Weight of the laboratories in implementing of

GLP

The results show differential in implementing of GLP in

surveyed laboratories between (36.4% to 89.6% weight)
depending of the facilities of each lab and its infrastructure
and the activities of the lab personals in implementing the
requirements of GLP. The study recommended to
rehabilitation the infrastructure of these laboratories which
has obtained low (% weight), and creating a new plan for
establishing the quality management system in the
laboratory.

References
[1] Jurg P. Seiler. (2005). Good Laboratory Practice,
Springer 2nd Edition. Thomas Mager, Heidelberg.
[2] Ashok Alatgi, Sanjeev Chougule (2015). Good
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and Dental Sciences.
[3] Good Laboratory Practice for Iraqi lab (2015).
Guidance document on Iraqi lab Organization for
Economic Co-operation and Development - Baghdad.
[4] Department of Quality Assurance. (2016). Instructions
for implementing GLP. University of Baghdad.
[5] R. Selvakumar (2010). Good Laboratory Practices.
Indian Journal of Clinical and Biochemistry.
[6] Renata Almeida de Souza and others. (2011).
Implementation of Good Laboratory Practices in a
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Verlag.
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Part 3. Journal of Chemical Education USA.
[8] Good Laboratory Practice Regulation (1987). Food and
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Volume 6 Issue 2, February 2017

www.ijsr.net
Licensed Under Creative Commons Attribution CC BY
Paper ID: 4021703 DOI: 10.21275/4021703 464