Icmr Guidelines for Good clinical Laboratory Practices ...

1 IcmrGuidelines forGood clinical Laboratory Practices (GcLP) 2021 Compiled by: Dr. Monika PahujaEdited by: Dr. Puneet K. Nigam and Dr. Vijay Kumar ICMR, New DelhiGood clinical Laboratory Practices Guidelines , 20212nd edition Indian Council of Medical Research 2021. All rights reserved Publications of the ICMR can be obtained from ICMR-HQ, Division of Basic Medical Sciences, Indian Council of Medical Research, Ansari Nagar, New Delhi, for permission to reproduce or translate ICMR publications whether for sale or for non-commercial distribution should be addressed to ICMR-Hq at the above has been taken to present the information accurately, however the reader is urged to check latest notifications/rules/regulations by GOI from time to responsibility for the interpretation and use of the material lies with the no event shall ICMR be liable for damages arising from its use.

2 FOREWORDG lobally, in the last few decades there has been a rapid expansion in the different branches of health care services, as well as in the field of medical research. Consumer awareness and expectation of health care have simultaneously improved with increasing demands for high quality care, including Laboratory services. It is well recognized that Laboratory quality will significantly improve if the entire process is addressed in the quality system. Towards this goal, the laboratories should meticulously implement Good clinical Laboratory Practices (GCLP) that will ensure timely and accurate processing of biological samples enabling early and accurate diagnosis and patient safety leading to desired clinical the objective of promoting uniformity in maintaining quality of Laboratory services, the Indian Council of Medical Research released the first GCLP Guidelines in the year 2008.

3 Keeping in view of recent advances, the ICMR has now revised the 2008 document. The revised Guidelines for Good clinical Laboratory Practices 2021 aim to establish minimum criteria which should be followed by clinical and research laboratories involved in examining human samples, in routine healthcare delivery and clinical research, respectively. GCLP compliance will certainly empower clinical laboratories and clinical researchers to provide data that are reliable. Adoption of these GCLP Guidelines by laboratories in public sector, private sector and research institutions will be a significant step forward in the betterment of health care services and health research in efforts of the team of scientists and experts from ICMR and from other institutions who worked meticulously in bringing out the Guidelines for GCLP 2021 deserve A S KanagasabapathyChairman, Drafting/Advisory CommitteeFormer Prof.

4 & Head, Deptt. of clinical Biochemistry Christian Medical College, VellorePREFACEOver the years, clinical laboratories have gained tremendous importance in health care services. Laboratory investigations are essential for medical diagnosis in patient care as well as medical research. Reliability of Laboratory data/report is therefore of paramount importance. Good clinical Laboratory Practices (GCLP) is essential to be implemented in the field of medical research and health care services to ensure reliability of Laboratory data. Keeping this in view, ICMR constituted an Advisory Committee to develop the Guidelines for GCLP in the year 2008. This document has now been revised as Guidelines for Good clinical Laboratory Practices 2021 to be adopted uniformly in medical laboratories involved in clinical research and/or patient care in India.

5 One major addition in the scope of updated Guidelines is the inclusion of clinical research involving human participants. The Guidelines are also projected to establish facilities with evolving strategies in pre-examination and examination processes of samples from clinical research and testing laboratories to assure the quality, reliability and integrity of the data generated. The directives require that Guidelines for compliance monitoring procedures for GCLP and the Guidelines for conduct of test facility inspection and study audit must be followed periodically to ensure reliability and integrity of data generated by is expected to play a lead role in providing support and training activities to all medical research institutions, universities and clinical research laboratories to promote uniform adoption of these Guidelines which will enable in improving the safety and integrity of test results and to follow the quality standards, ethical conduct and regulatory compliance as mandated by GCLP Guidelines .

6 Dr. Vijay Kumar Former Scientist G and Head, Division of Basic Medical Sciences, Indian Council of Medical Research (ICMR)ACKNOWLEDGEMENTThe revised Good clinical Laboratory Practices (GCLP) Guidelines , 2021 is an ardent, complex task taken up by a drafting committee. We extend a sincere thanks to Prof. Kanagasabapathy for his esteemed chairmanship and guidance in building up this document. This could not have been possible without the continued support and directions from Dr. Shalini Singh as the team led by her, had prepared the first version of the Guidelines on Good clinical Laboratory Practices (GCLP), 2008 that made our task of bringing the 2nd edition easier. Our special thanks to Dr. Bikash Mehdi, Dr. Arti kapil, Dr. Rana, Dr. Usha Aggarwal, Dr.

7 R. Lakshmi, Dr. Purva Mathur and Dr. Heena Tabassum for helping us to draft the document as per the current clinical scenarios and in accordance with existing rules and regulations. The document would not have been complete without important inputs on various aspects of clinical Laboratory Practices provided by Dr. Puneet K. Nigam. We also acknowledge the inputs from Dr. Ruchika Gupta and Dr. Dinesh Kumar in compilation of document. ICMR gratefully acknowledge the contributions made by various stakeholders for their comments and suggestions on the draft Guidelines and shaping for its finalization. Sincere thanks to team ICMR including Sh. Sandhu, Sh. Amal Verma, and Ms. Shivani Bhola for necessary administrative and logistics arrangements for successfully holding drafting committee meetings.

8 The patronage of Prof. Balram Bhargava, Secretary, Department of Health Research and DG, ICMR is deeply acknowledgedDr. Monika Pahuja Scientist C Division of Basic Medical Sciences, Indian Council of Medical Research (ICMR)CONTENTSABBREVIATIONS i-iiDEFINITIONS iii-viChapter-1 INTRODUCTION 1 Chapter-2 SCOPE 2 Chapter-3 LEVELS OF LABORATORIES Primary Level Secondary Level Tertiary Level Reference Laboratories, Research Laboratories 5 and Specific Disease Reference For Collection Centres 5 Chapter-4 INFRASTRUCTURE 6 Chapter-5 PERSONNEL, TRAINING AND DEVELOPMENT General Personnel Training 9 Chapter-6 EQUIPMENT 12-15 Chapter-7 REAGENTS AND MATERIALS 15 Chapter-8 PRE EXAMINATION PROCESS Patient Preparation Primary Sample Collection Primary Sample Collection Device Samples of clinical Research/Trial Sample Labeling and Documentation Requisition Form/Test Request Form Transportation of Samples 18 Chapter-9 SAMPLE ACCEPTANCE/REJECTION 19 Chapter-10 EXAMINATION PROCESSES General Examination Procedures Performance characteristics 21 Chapter-11 RELEASE OF TEST RESULTS

9 22 GCLP Guidelines 2021 Chapter-12 SAMPLE STORAGE/DISPOSAL Sample storage Sample/Chemical/e-waste disposal 23 Chapter-13 SAFETY IN LABORATORIES General Safety Measures Laboratory Safety Chemical Hygiene Plan Laboratory Hygiene and Sanitation Personal Hygiene Electrical safety Biosafety Precautions Biological safety cabinets (BSCs) 34 Chapter-14 ETHICAL CONSIDERATIONS 34 Chapter-15 QUALITY MANAGEMENT 36 Chapter-16 INTERNAL QUALITY CONTROL IQC for Quantitative Tests IQC for Qualitative Tests Reagent Lot Verification 39 Chapter-17 EXTERNAL QUALITY ASSESSMENT/ PROFICIENCY TESTING 40 Chapter-18 INTERNAL AUDIT 41 Chapter-19 TECHNICAL AUDIT CHECKLIST 41 Chapter-20 RISK MANAGEMENT 42 Chapter-21 QUALITY INDICATORS 42 Chapter-22 DATA MANAGEMENT Data integrity Confidentiality Data Security Laboratory Record 46 References 48 Annexure 1-7 50-56 Figure 1-2

10 57-58iABBREVIATIONSAERB Atomic Energy Regulatory BoardAMR Analytical Measurement Range APAC Asia Pacific Accreditation Cooperation BARC Bhabha Atomic Research CentreBSC Biological Safety Cabinet CHC Community Health CentreCHP Chemical Hygiene PlanCLSI clinical and Laboratory Standards Institute CRR clinical Reportable RangeCV Coefficient of VariationEC Ethics CommitteeELISA Enzyme-Linked Immunosorbent AssayEQA External Quality AssessmentFRU First Referral UnitGCP Good clinical PracticeGMT Good Microbiological TechniquesHEPA High-Efficiency Particulate AirHIS Hospital Information SystemHIV Human Immunodeficiency VirusIDSP Integrated Disease Surveillance ProgramIPD Inpatient Department IQ Installation Qualification IQC Internal Quality ControlIRL Intermediate level Reference LaboratoryISO International Organization for Standardization LIS Laboratory Information SystemMRA Mutual Recognition AgreementGCLP Guidelines 2021iiNABL National Accreditation Board for Testing and Calibration LaboratoriesNPL National Physical LaboratoryNRL National Reference LaboratoryOPD Out Patients DepartmentOQ Operational Qualification PHC Primary Health CentrePPE Personal Protective Equipment PQ Performance QualificationQA Quality AssuranceQC Quality ControlQMS Quality Management SystemQS Quality SystemRNTCP Revised National TB Control ProgramRPR Rapid Plasma ReaginRTI Reproductive Tract InfectionsSDI Standard Deviation IndexSDS