This course "Good Laboratory Practices" will guide the students through the basics of good lab practices, ensuring safety and risk management, delve deeper into quality control and assurance, and finally explore the implementation of these practices in specialized areas like clinical, diagnostic, and research labs. The syllabus will provide a deep understanding of laboratory standard operating procedures, quality improvement cycles, the role of proficiency testing, and the ethical considerations involved in lab practices. Through a series of case studies, students will also be exposed to practical, real-world scenarios where they can apply their theoretical knowledge. Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com

1. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
Program Name: B.Sc. Medical Lab Technology
Syllabus of Program Elective course - I (Good lab practies)
Course Name: Program Elective course - I (Good lab practies) Course Type
Course Coordinator: Attuluri Vamsi Kumar – B.Sc. MLT, M.Sc. MLT, PhD (Perusing)
Designation: Assistant Professor
Department: Department of Medical Lab Technology (MLT)
Program
Elective
PRE-REQUISITE Basic life sciences up to 10+2 level Sem: 2 S. No: 16
About Vamsi: I am academician in Medical Laboratory Sciences with a strong desire to improve Outcome
based education (OBE) structured MLT education. I am constantly focusing on building an academic
atmosphere that is set high standards with strong multi blended teaching pedagogy models.
YouTube: https://www.youtube.com/@vamsiMLT
SlideShare: https://www.slideshare.net/VamsiIntellectual
Website: www.mltmaster.com / https://sites.google.com/view/vamsi-intellectual-protfolio/home
LinkedIn: https://www.linkedin.com/in/vamsi-kumar-attuluri-ab8987128/?originalSubdomain=in
Research Gate: https://www.researchgate.net/profile/Attuluri-Kumar
Orcid ID: https://orcid.org/0000-0001-9278-6714
Contact No: +91 7416660584
Mail ID: vamsifmlt@gmail.com
A. COURSE DESCRIPTION
This course "Good Laboratory Practices" will guide the students through the basics of good
lab practices, ensuring safety and risk management, delve deeper into quality control and
assurance, and finally explore the implementation of these practices in specialized areas like
clinical, diagnostic, and research labs. The syllabus will provide a deep understanding of
laboratory standard operating procedures, quality improvement cycles, the role of proficiency
testing, and the ethical considerations involved in lab practices. Through a series of case
studies, students will also be exposed to practical, real-world scenarios where they can apply
their theoretical knowledge.
B. COURSE OBJECTIVES:
1. Recall the principles and importance of Good Laboratory Practices, as well as the key aspects of
laboratory safety and risk management.
2. Understand the concepts of quality control and quality assurance in the context of laboratory
practices.
3. Apply the concepts of quality control and assurance to analyze real-world case studies and identify
areas of improvement in given scenarios.
4. Analyze different laboratory practices in specialized areas such as clinical, diagnostic, and research
labs, and understand how GLP is implemented in these contexts.
5. Evaluate ethical considerations in laboratory practices and make informed judgments about proper
conduct in various laboratory settings.
C. COURSE OUTCOMES
CO
No
Statement Performance
Indicator
Level of
Learning
(Highest BT
Level)
Target
Attainment
CO1 Students will be able to recall and identify key
concepts of Good Laboratory Practices and safety
regulations in laboratory settings.
PI 1, PI 7, PI 8 K1:
Remembering
70%

2. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
CO2 Students will comprehend the principles of quality
control and quality assurance in laboratory practices
and understand the importance of risk management.
PI 2.1, PI 2.4,
PI 2.5, PI 4
K2:
Understanding
70%
CO3 Students will apply the knowledge of GLP, quality
control, and assurance to solve problems and
suggest improvements in laboratory settings.
PI 2.2, PI 2.3,
PI 2.6, PI 2.7,
PI 3, PI 6
K3: Applying 70%
CO4 Students will be capable of analyzing case studies
and real-world situations to identify issues and
inefficiencies in laboratory practices.
PI 2.8, PI 3, PI
6
K4: Analyzing 70%
CO5 Students will evaluate the effectiveness of GLP in
various laboratory settings, such as clinical,
diagnostic, and research labs, and make informed
decisions.
PI 2.9, PI 4, PI
10
K5: Evaluating 70%
CO6 Students will be able to develop strategies and
protocols for enhancing the quality and safety of
laboratory practices, applying ethical
considerations, and upholding good laboratory
practices.
PI 5, PI 6, PI 9,
PI 10
K6: Creating 70%
D. SYLLABUS
Unit-1 Basics of Good Laboratory Practices Contact Hours:15
Chapter 1.1 Introduction to Good Laboratory Practices- Definition and Importance of Good Laboratory
Practices, Historical Background, Regulatory Aspects
Chapter 1.2 Laboratory Safety and Risk Management- Laboratory Hazards (Chemical, Biological,
Physical), Personal Protective Equipment (PPE), Risk Assessment, Emergency Preparedness
Experiment 1 /
Case study
Case study: Exploring the Thalidomide Tragedy and the Origin of Regulatory Practices
Experiment 2 /
Case study
Case study: Comparison of Laboratory Practices in Different Countries: The Importance of
Standardization
Experiment 3 /
Case study
Case study: Analysis of Bhopal Gas Tragedy: Safety Failures and Lessons Learnt
Unit-2 Quality Control and Assurance in Laboratory Contact Hours:15
Chapter 2.1 Principles of Quality Control and Assurance - 16
Chapter 2.2 Implementation of Quality Control and Assurance in Lab- Standard Operating Procedures
(SOPs), Quality Control Samples, Inter-laboratory Comparison and Proficiency Testing
Experiment 4 /
Case study
Case Study 4: Evaluating the Role of Quality Control in the Flint Water Crisis
Experiment 5 /
Case study
Case Study 5: Understanding the Importance of Quality Assurance with the Help of HIV
Testing Errors
Experiment 6 /
Case study
Case Study 6: Case Analysis of Inadequate Quality Control in a Pathology Laboratory
Experiment 7 /
Case study
Case Study 7: The Role of Proficiency Testing in Detecting the Zika Virus
Unit-3 Good Laboratory Practices in Specialized Areas Contact Hours:15
Chapter 3.1 GLP in Clinical and Diagnostic Labs- Importance of GLP in Clinical Labs, GLP in
Diagnostic Labs, Errors in Laboratory Testing, Patient Safety
Chapter 3.2 GLP in Research Labs- GLP in Pre-clinical Studies, Documentation and Data Integrity, GLP
Compliance for Research Labs, Ethical Considerations
Experiment 8 /
Case study
Case Study 8: Case Review of Laboratory Errors Leading to Misdiagnosis
Experiment 9 /
Case study
Case Study 9: Impact of Good Laboratory Practices on COVID-19 Testing Accuracy
Experiment 10 / Case Study 10: Evaluation of Data Integrity Issues in a High-Profile Research Fraud Case

3. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
Case study
Self-study topics for Advance learners: Good Laboratory Practices and Safety Measures: Risk
Assessment and Mitigation in the Lab, Advanced Chemical Safety and Waste Disposal, Regulatory
and Ethical Standards:Review of International Regulatory Agencies and their GuidelinesAdvanced
Ethics in Lab Practice, Quality Control and Quality Assurance in Labs: Advanced Quality Control and
Assurance:
Application of Six Sigma in Lab Quality Control, Advanced Principles of ISO 15189, Quality
Management Systems,
Implementing and Managing Quality Management Systems in Lab, Risk Management in Lab
Operations
E. TEXT BOOKS/REFERENCE BOOKS
TEXT BOOKS
T1 Good Laboratory Practice Regulations by Sandy Weinberg
T2 Good Laboratory Practice: Nonclinical Laboratory Studies Concise Reference by S. A.
Barker
T3 Principles of Good Laboratory Practice by A. K. Saha
REFERENCE BOOKS
R1 A Practical Guide to Laboratory Quality Control in Clinical Biochemistry by Rita Horvath
and William Simpson
R2 Management of Laboratory Animal Care and Use Programs by Robert H. Weichbrod, Gail
A. (Heidbrink) Thompson, and John N. Norton
R3 Handbook of Laboratory Health and Safety Measures by S. K. Pal

4. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
Code Performance Indicators
PI 1 Demonstrate professional interpersonal, oral, and written communications skills sufficient to
serve the needs of patients and the public including an awareness of how diversity may affect
the communication process.
PI 2 Perform pre-analytical, analytical, and post-analytical processes:
PI 2.1 Demonstrate ability to understand investigation/test requisition.
PI 2.2 Collecting the relevant clinical samples along with complete and accurate documentation with
proper safety measures in relation to sample accountability.
PI 2.3 To transport the samples with precautionary measures to the relevant lab section.
PI 2.4 Demonstrate the ability to prepare clinical sample for processing
PI 2.5 To demonstrate the knowledge of accurate sample processing for the required lab
investigation. Perform routine clinical laboratory tests in clinical chemistry,
haematology/haemostasis, immunology, immunohematology, microbiology, Histopathology,
Cytopathology, body fluid analysis, and laboratory operations.
PI 2.6 Perform mathematical calculations related to all areas of the clinical laboratory
PI 2.7 Ability to record the test results/data.
PI 2.8 To demonstrate the ability to interpret the test reports and its documentation in lab records.
PI 2.9 Demonstrate ability to release the report to the right person in minimum turn-around time
(TAT).
PI 3 Perform problem solving and troubleshooting techniques for laboratory methodologies
Correlate laboratory test results with patient diagnosis and treatment.
PI 4 To follow basic quality assessment protocol of clinical laboratory.
PI 5 Demonstrate routine laboratory techniques sufficient to orient new employees within the
clinical laboratory.
PI 6 Apply basic scientific principles in learning new techniques/procedures; demonstrate
application of principles and methodologies.
PI 7 Utilize computer technology applications to interact with computerized instruments and
laboratory information systems.
PI 8 Demonstrate adequate knowledge of computer software as it applies to document production,
spreadsheets, and presentations.
PI 9 Demonstrate professional behaviour with co-team mates.
PI 10 Demonstrate sensitivity and compassion towards patients.