The document outlines the principles and regulations of Good Laboratory Practice (GLP) and laboratory accreditation, highlighting their importance in ensuring quality, reliability, and regulatory compliance in non-clinical studies. It details the key aims of GLP and accreditation, including enhancing credibility, facilitating regulatory reviews, and promoting international acceptance of studies. Additionally, it discusses various national and international accreditation agencies that contribute to maintaining high standards in clinical laboratories.

1. GOOD LABORATORY PRACTICE (GLP) REGULATIONS AND
ACCREDITATION: A. INTRODUCTION TO BASICS OF GLP AND
ACCREDITATION, B. AIMS OF GLP AND ACCREDITATION, C.
ADVANTAGES OF ACCREDITATION, D. BRIEF KNOWLEDGE
ABOUT NATIONAL AND INTERNATIONAL AGENCIES FOR
CLINICAL LABORATORY ACCREDITATION
DR. JAGROOP SIDHU
PHD BIOCHEMISTRY
GOVERNMENT MEDICAL COLLEGE AMRITSAR

2. • WHAT IS GLP?
• DEFINITION:
• GOOD LABORATORY PRACTICE (GLP) IS A SET OF PRINCIPLES INTENDED TO ENSURE
THE QUALITY AND INTEGRITY OF NON-CLINICAL LABORATORY STUDIES.
• HISTORICAL BACKGROUND:
• ORIGINATED IN THE 1970S IN RESPONSE TO CONCERNS ABOUT THE VALIDITY OF NON-
CLINICAL SAFETY DATA.
• FIRST INTRODUCED BY THE FDA IN THE UNITED STATES.

3. • IMPORTANCE OF GLP
• ENSURES QUALITY AND RELIABILITY:
• GLP ENSURES THAT LABORATORY STUDIES ARE CONDUCTED WITH HIGH QUALITY AND
RELIABLE STANDARDS.
• REGULATORY COMPLIANCE:
• COMPLIANCE WITH GLP IS OFTEN A LEGAL REQUIREMENT FOR LABORATORIES
CONDUCTING NON-CLINICAL STUDIES INTENDED FOR REGULATORY SUBMISSION.
• ENHANCES CREDIBILITY:
• ADHERENCE TO GLP INCREASES THE CREDIBILITY OF LABORATORY DATA AND
FINDINGS.

4. • CORE PRINCIPLES OF GLP
• STUDY PLAN AND CONDUCT:
• CLEARLY DEFINED STUDY PROTOCOLS.
• RESPONSIBILITIES OF THE STUDY DIRECTOR.
• FACILITIES:
• ADEQUATE DESIGN, MAINTENANCE, AND CLEANLINESS OF LABORATORY FACILITIES.
• EQUIPMENT:
• PROPER CALIBRATION, VALIDATION, AND MAINTENANCE OF EQUIPMENT.
• PERSONNEL:
• TRAINING, QUALIFICATIONS, AND COMPETENCY OF LABORATORY STAFF.

5. • WHAT IS ACCREDITATION?
• DEFINITION:
• ACCREDITATION IS THE FORMAL RECOGNITION BY AN
AUTHORITATIVE BODY THAT A LABORATORY OPERATES
ACCORDING TO INTERNATIONALLY ACCEPTED
STANDARDS.
• PURPOSE:
• ENSURES THAT LABORATORIES ARE COMPETENT TO
CARRY OUT SPECIFIC TASKS AND PRODUCE RELIABLE
RESULTS.

6. • ACCREDITATION VS. CERTIFICATION
• ACCREDITATION:
• A RIGOROUS EVALUATION PROCESS THAT ASSESSES THE COMPETENCE AND QUALITY
OF A LABORATORY.
• INVOLVES ONGOING ASSESSMENTS TO MAINTAIN ACCREDITATION STATUS.
• CERTIFICATION:
• FOCUSES ON COMPLIANCE WITH SPECIFIC STANDARDS.
• OFTEN INVOLVES A ONE-TIME EVALUATION OR PERIODIC REVIEW WITHOUT
CONTINUOUS MONITORING.

7. • AIMS OF GLP - ENSURING HIGH QUALITY AND RELIABLE DATA
• CONSISTENCY:
• GLP PROMOTES CONSISTENT METHODOLOGIES AND PRACTICES IN LABORATORIES.
• ACCURACY:
• ENSURES THAT DATA GENERATED IS ACCURATE AND REFLECTS TRUE FINDINGS.
• REPRODUCIBILITY:
• ENABLES REPRODUCIBILITY OF EXPERIMENTS AND STUDIES BY OTHER RESEARCHERS.

8. • AIMS OF GLP - FACILITATING REGULATORY REVIEWS
• REGULATORY COMPLIANCE:
• GLP-COMPLIANT DATA MEETS REGULATORY REQUIREMENTS, FACILITATING THE
APPROVAL PROCESS.
• STREAMLINED REVIEW:
• SIMPLIFIES THE REVIEW PROCESS FOR REGULATORY BODIES BY ENSURING
STANDARDIZED DOCUMENTATION AND PRACTICES.
• TRUST AND TRANSPARENCY:
• BUILDS TRUST AND TRANSPARENCY BETWEEN LABORATORIES AND REGULATORY
AUTHORITIES.

9. • AIMS OF GLP - PROMOTING INTERNATIONALACCEPTANCE OF STUDIES
• STANDARDIZATION:
• GLP ESTABLISHES INTERNATIONALLY RECOGNIZED STANDARDS.
• GLOBAL RECOGNITION:
• DATA FROM GLP-COMPLIANT STUDIES ARE ACCEPTED GLOBALLY, FACILITATING
INTERNATIONAL COLLABORATIONS AND SUBMISSIONS.
• CROSS-BORDER RESEARCH:
• SUPPORTS CROSS-BORDER RESEARCH AND DEVELOPMENT BY PROVIDING A COMMON
FRAMEWORK.

10. • AIMS OF GLP - ENHANCING CREDIBILITY AND TRUST
• INTEGRITY:
• GLP ENSURES THE INTEGRITY OF DATA, REDUCING THE RISK OF FRAUD OR
MANIPULATION.
• CONFIDENCE:
• ENHANCES CONFIDENCE IN THE FINDINGS AND CONCLUSIONS DRAWN FROM STUDIES.
• STAKEHOLDER ASSURANCE:
• ASSURES STAKEHOLDERS, INCLUDING REGULATORS, SPONSORS, AND THE PUBLIC.

11. • AIMS OF ACCREDITATION - IMPROVING LABORATORY QUALITY
• CONTINUOUS IMPROVEMENT:
• ENCOURAGES ONGOING IMPROVEMENTS IN
LABORATORY PROCESSES AND OUTCOMES.
• BENCHMARKING:
• ESTABLISHES BENCHMARKS FOR QUALITY AND
PERFORMANCE.
• QUALITY MANAGEMENT:
• PROMOTES THE IMPLEMENTATION OF QUALITY
MANAGEMENT SYSTEMS.

12. • AIMS OF ACCREDITATION - STANDARDIZING PROCEDURES AND PROTOCOLS
• UNIFORMITY:
• ENSURES UNIFORMITY IN LABORATORY OPERATIONS
AND PROCEDURES.
• CONSISTENCY:
• PROMOTES CONSISTENT APPLICATION OF PROTOCOLS
ACROSS DIFFERENT LABORATORIES.
• COMPLIANCE:
• HELPS LABORATORIES COMPLY WITH ESTABLISHED
STANDARDS AND REGULATIONS.

13. • AIMS OF ACCREDITATION - BOOSTING LABORATORY COMPETENCE
• COMPETENCE VERIFICATION:
• ASSESSES AND VERIFIES THE COMPETENCE OF
LABORATORY PERSONNELAND PROCESSES.
• TRAINING AND DEVELOPMENT:
• ENCOURAGES CONTINUOUS TRAINING AND PROFESSIONAL
DEVELOPMENT.
• PERFORMANCE MONITORING:
• REGULAR MONITORING AND ASSESSMENT OF LABORATORY
PERFORMANCE.

14. • AIMS OF ACCREDITATION - ENSURING COMPLIANCE WITH REGULATORY
REQUIREMENTS
• REGULATORY ALIGNMENT:
• ENSURES ALIGNMENT WITH NATIONAL AND INTERNATIONAL REGULATORY
STANDARDS.
• LEGAL COMPLIANCE:
• HELPS LABORATORIES COMPLY WITH LEGAL AND REGULATORY REQUIREMENTS.
• RISK MANAGEMENT:
• ENHANCES RISK MANAGEMENT PRACTICES BY IDENTIFYING AND ADDRESSING
POTENTIAL ISSUES.

15. • ENSURES QUALITY
• STANDARDIZED PROCESSES
• ACCREDITATION ENFORCES ADHERENCE TO
STANDARDIZED PROCEDURES.
• CONTINUOUS IMPROVEMENT
• ENCOURAGES ONGOING QUALITY ENHANCEMENTS.

16. • BUILDS TRUST AND CREDIBILITY
• PUBLIC CONFIDENCE
• ACCREDITATION BOOSTS PUBLIC TRUST IN
INSTITUTIONS AND SERVICES.
• REPUTATION
• ENHANCES INSTITUTIONAL CREDIBILITY AND
PRESTIGE.

17. • FACILITATES REGULATORY COMPLIANCE
• REGULATORY ALIGNMENT
• MEETS LOCAL, NATIONAL, AND INTERNATIONAL
STANDARDS.
• SIMPLIFIED COMPLIANCE
• EASES THE PROCESS OF REGULATORY COMPLIANCE.

18. • ENHANCES MARKETABILITY
• ATTRACTION OF TALENT
• DRAWS TOP STUDENTS, EMPLOYEES, AND PARTNERS.
• COMPETITIVE EDGE
• PROVIDES A MARKET ADVANTAGE OVER NON-
ACCREDITED ENTITIES.

19. • PROMOTES CONTINUOUS IMPROVEMENT
• INNOVATION ENCOURAGEMENT
• FOSTERS AN ENVIRONMENT OF INNOVATION.
• FEEDBACK LOOPS
• ESTABLISHES MECHANISMS FOR PERFORMANCE
FEEDBACK.
• VISUAL: DIAGRAM OF THE INNOVATION CYCLE

20. • SUPPORTS ACCOUNTABILITY
• TRANSPARENCY
• ENSURES TRANSPARENCY IN OPERATIONS AND
OUTCOMES.
• MEASURABLE OUTCOMES
• PROVIDES MEASURABLE PERFORMANCE METRICS.

21. • ENCOURAGES PROFESSIONAL DEVELOPMENT
• TRAINING OPPORTUNITIES
• PROVIDES PROFESSIONAL DEVELOPMENT AND
TRAINING.
• CAREER GROWTH
• ENHANCES CAREER ADVANCEMENT OPPORTUNITIES.

22. • ENHANCES CUSTOMER SATISFACTION
• SERVICE QUALITY
• IMPROVES THE QUALITY OF SERVICES OFFERED.
• FEEDBACK UTILIZATION
• INCORPORATES CUSTOMER FEEDBACK INTO
IMPROVEMENTS.
• VISUAL: CUSTOMER SATISFACTION SURVEY RESULTS.

23. • INCREASES FUNDING OPPORTUNITIES
• GRANT ACCESS
• EASIER ACCESS TO GRANTS AND FUNDING.
• INVESTOR CONFIDENCE
• ATTRACTS INVESTORS DUE TO PROVEN STANDARDS.
• VISUAL: IMAGE REPRESENTING FINANCIAL GROWTH OR FUNDING.

24. • IMPROVES OPERATIONAL EFFICIENCY
• RESOURCE MANAGEMENT
• OPTIMIZES USE OF RESOURCES.
• PROCESS EFFICIENCY
• STREAMLINES PROCESSES AND PROCEDURES.

25. • STRENGTHENS INSTITUTIONAL INTEGRITY
• ETHICAL STANDARDS
• UPHOLDS HIGH ETHICAL STANDARDS.
• INSTITUTIONAL INTEGRITY
• REINFORCES THE INTEGRITY OF THE INSTITUTION.

26. • BOOSTS RESEARCH CAPABILITIES (FOR RESEARCH INSTITUTIONS)
• RESEARCH QUALITY
• ENHANCES THE QUALITY AND CREDIBILITY OF
RESEARCH.
• COLLABORATION OPPORTUNITIES
• FACILITATES RESEARCH COLLABORATIONS.

27. • PROVIDES EXTERNAL VALIDATION
• THIRD-PARTY REVIEW
• EXTERNAL VALIDATION OF STANDARDS AND
PRACTICES.
• OBJECTIVE ASSESSMENT
• UNBIASED EVALUATION OF PERFORMANCE.

28. • ENHANCES RISK MANAGEMENT
• RISK REDUCTION
• REDUCES OPERATIONAL AND REPUTATIONAL RISKS.
• CRISIS MANAGEMENT
• IMPROVES CRISIS MANAGEMENT CAPABILITIES.

29. • IMPROVES PATIENT CARE (FOR HEALTHCARE INSTITUTIONS)
• CARE STANDARDS
• ENSURES HIGH STANDARDS OF PATIENT CARE.
• PATIENT SAFETY
• ENHANCES PATIENT SAFETY PROTOCOLS.

30. • NATIONALAGENCIES:
1.COLLEGE OFAMERICAN PATHOLOGISTS (CAP):
1. BASED IN THE UNITED STATES, CAP OFFERS ACCREDITATION FOR CLINICAL
LABORATORIES WORLDWIDE. THEIR PROGRAM INCLUDES INSPECTIONS, PROFICIENCY
TESTING, AND COMPLIANCE WITH REGULATORY REQUIREMENTS.
2. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA):
• OPERATED BY THE CENTERS FOR MEDICARE & MEDICAID SERVICES
(CMS) IN THE UNITED STATES, CLIA REGULATES LABORATORY
TESTING AND REQUIRES CLINICAL LABORATORIES TO BE CERTIFIED
TO TEST HUMAN SPECIMENS.

31. 3. NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION
LABORATORIES (NABL):
• LOCATED IN INDIA, NABL PROVIDES TESTING AND CALIBRATION LABORATORY
ACCREDITATION BASED ON INTERNATIONAL STANDARDS. IT ENSURES THAT
LABORATORIES MEET TECHNICAL AND MANAGEMENT SYSTEM REQUIREMENTS.

32. • INTERNATIONALAGENCIES:
1.INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO):
1. ISO 15189:2012 SPECIFICALLY ADDRESSES REQUIREMENTS FOR QUALITY AND
COMPETENCE IN MEDICAL LABORATORIES. IT'S A WIDELY RECOGNIZED
INTERNATIONAL STANDARD FOR CLINICAL LABORATORY ACCREDITATION.
2.INTERNATIONAL LABORATORYACCREDITATION COOPERATION (ILAC):
1. ILAC PROMOTES INTERNATIONAL COOPERATION FOR LABORATORY ACCREDITATION
AND RECOGNITION OF ACCREDITED LABORATORIES WORLDWIDE. THEY WORK TO
HARMONIZE STANDARDS AND IMPROVE LABORATORY QUALITY GLOBALLY.

33. 3. EUROPEAN CO-OPERATION FOR ACCREDITATION (EA):
EA PROVIDES ACCREDITATION FOR TESTING AND CALIBRATION LABORATORIES
ACROSS EUROPE, ENSURING THEY MEET SPECIFIED TECHNICAL COMPETENCE
AND QUALITY MANAGEMENT SYSTEM REQUIREMENTS.
• THESE AGENCIES PLAY CRUCIAL ROLES IN ENSURING THAT CLINICAL
LABORATORIES MAINTAIN HIGH QUALITY, ACCURACY, AND RELIABILITY
STANDARDS IN THEIR TESTING PROCESSES, ULTIMATELY BENEFITING PATIENT
CARE AND HEALTHCARE OUTCOMES GLOBALLY.

34. THANK YOU