National Accreditation Board For Testing and Calibration Laboratories (NABL).pptx

National Accreditation Board For Testing and Calibration Laboratories (NABL),
Authors : Isha V. Selokar , Achal A. Lanjewar, B Pharm Final Year
Subject: Industrial Pharmacy - II

1. National Accreditation Board For Testing and Calibration Laboratories ( NABL ) Isha V. Selokar , Achal A. Lanjewar , B Pharm Final Year Subject: Industrial Pharmacy - II Guide: Chandrashekhar M. Chakole, Associate Professor, BKCP, Sakoli BAJIRAOJI KARANJEKAR COLLEGE OF PHARMACY (BKCP), SAKOLI , 441802 RASHTRASANT TUKADOJI MAHARAJ UNIVERSITY NAGPUR , M.S. INDIA

2. CONTENT 1. Introduction 2. Principles Of NABL Accreditation 3. Importance Of Accreditation 4. Benefits Of Accreditation 5. Vision And Mission Of NABL 6.NABL Accreditation Areas 7.Organization Structure Of NABL 8. NABL Accreditation Procedure

3. INTRODUCTION NABL is anatonomus society providing Accreditation of Technical competence of testing , calibration , medical laboratory and Proficiency testing provider (PTP) & Reference Material Producer ( RMP ). NABL  stands for National  Accreditation Board For Testing  And Calibration Laboratories. NABL has agreements with ILAC ( International Laboratory  Accreditation Conference )& APLAC  ( Asia  Pacific Laboratory accreditation Cooperation ). Accreditation provides formal recognition of the technical competence of a laboratory for particular measurements or tests based on results from a third party assessments.                                                                                          10/11/2025 3

4. Principle of nabl accreditation A laboratory's technical competence and the reliability of its test results, promoting impartiality, ensuring confidentiality, and requiring continuous improvement of its management and technical operations to comply with international standards like ISO/IEC 17025. Competence & Quality Assurance:   Laboratories must demonstrate both technical and tester competence, ensuring their processes and equipment are appropriate and staff are qualified to produce accurate and reliable results.  Impartiality & Independence:   The accreditation process and the laboratory's operations must be free from undue influence or conflicts of interest to maintain objectivity and trust in the results.  Confidentiality:   Labs must protect the confidentiality of their clients' information and proprietary data, fostering a secure and trusted environment.  Consistent & Reliable Results:   NABL accreditation ensures that a laboratory can consistently produce dependable and valid results from all tests and calibration. 10/11/2025 4

5. Importance of accreditation The Concepts of Laboratory Accreditation developed to provide a means of third party certification of the competence of laboratories to perform specific types of testing and calibration. Provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Enhances customer confindence in accepting testing calibration reports issued by accredited laboratories. It formally recognizes a laboratory’s competence, ensuring accurate and reliable test result. 10/11/2025 5

6. Benefits of accreditation 10/11/2025 6 Formal recognition of competence of a conformity assessment body by NABL in accordance with international standard has many advantages: ❖ International recognition, ❖ Access to Global market, ❖ Time and money efficient, ❖ Enhanced customer confidence and satisfaction, ❖ Robust Quality Management System, ❖ Continual improvements, ❖ Better operational control, ❖ Assurance of accurate and reliable results, ❖ Cost Reduction, ❖ Prevent loss due to defects

7. Vision and mission of nabl NABL Vision To be the world’s leading accreditation body and to enhance stakeholders’ confidence in its services. NABL Mission To strengthen the accreditation system accepted across the globe by providing high quality, value driven services, fostering APAC/ILAC MRA, empanelling competent assessors, creating awareness among the stake holders, initiating new programs supporting accreditation activities and pursuing organisational excellence. 10/11/2025 7

8. Nabl accreditation areas TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES Biological Electro- technical Clinical biochemistry Chemical Mechanical Clinical pathology Electrical Radiological Genetics Testing Thermal Cytopathology Thermal Optical Serology area Forensic Fluid flow Nuclear medicine 10/11/2025 8

9. Organization structure of nabl 10/11/2025 9

10. Nabl accreditation procedure Application by CAB to NABL for accreditation 10/11/2025 10 Acknowledgement & scrunity of application by NABL scretarait . Adequacy of quality manual Pre-assessment of laboratory by lead assessor Final assessment of laboratory by assessment team

11. 10/11/2025 11 Scrutiny of assessment report by NABL secretariat Recommendation for accreditation by accreditation committee Approval for accreditation by chairman of NABL Issue of NABL Certificate by NABL secretariat

12. 10/11/2025 12 NABL Accreditation Process 1️⃣ Make an Application by CAB to NABL - Institution submits an application with required documents to NABL.Application must be in triplicate (3 copies).Two copies should describe the quality manual of the management system.Must comply with ISO/IEC 17025:2005, ISO 15189:2012, ISO/IEC 17043:2010, or ISO 17034:2016. 2️⃣ Acknowledgment & Scrutiny of Application - Applicant pays the respective fee (as per NABL 100).If the applicant refuses certain disclosures, valid reasons must be provided. 3️⃣ Receipt of Application - NABL Secretariat issues a Unique Identification Number (UIN) after receiving the application and fee.Applicant must quote this UIN in all future correspondence with NABL. 4️⃣ Pre-Assessment Visit by Lead Assessor - If no discrepancies in the application, NABL appoints a lead assessor.Lead assessor conducts a pre-assessment visit to the CAB.Purpose : to check quality control practices and identify if further assessment is required. 5️⃣ Final Assessment by Assessment Team Once - CAB addresses issues, NABL forms a team (lead assessor + technical experts + other qualified members).

13. Reference International Regulatory Affairs Updates, 2005.Available at: http://www.iraup.com/about.php 2. Regulatory Affairs brought by Learning Plus, Inc.Available at: http://www.cgmp.com/ra.htm 3. The theory and practice of Industrial pharmacy – by Leon Lachman , Herbert A. Lieberman . 10/11/2025 13

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