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NABL ACCREDITATION

PHARMACEUTICAL QUALITY ASSURANCE

DEPARTMENT OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY

BIRLA INSTITUTE OF TECHNOLOGY, MESRA

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Contents

  • Introduction
  • Scope of NABL accreditation
  • NABL certification Vs NABL accreditation
  • Benefits of NABL accreditation
  • Accreditation process

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Learning Objective

The season will build your concept regarding NABL accreditation and its advantages.

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Introduction

National Accreditation Board for Testing and Calibration Laboratories (NABL)

  • It is an autonomous body
  • Registered under Societies Act in1992
  • Works under the support of Department of Science & Technology, Government of India

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Scope of NABL accreditation

NABL Grants accreditation in almost all areas of science, engineering and medical testing.

The international standards followed are

  • ISO 15189:2007 (for Medical Testing)
  • ISO 17025:2005 (for Testing, calibration)
  • ISO 17043:2010 (for PT providers)

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NABL Certification vs Accreditation

CERTIFICATION

ACCREDITATION

Certification is a comprehensive evaluation of a process, system, product, event, or skill typically measured against some existing norm or standard.

Accreditation is the formal declaration by a neutral third party that the certification program is administered in a way that meets the relevant norms or standards of certification program.

Uses criteria specifically developed to determine technical competence of the laboratory

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NABL Certification vs Accreditation

NABL Certification

NABL Accreditation

Certification does not make any statement about the technical competence of the laboratory.

Example ISO 9001:2005 Certification

This is an independent evaluation of laboratory’s technical competence

Accreditation example ISO 17025

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Take a pause

  • Why the NABL accreditation is required?

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Benefits of Accreditation

  • Customers

Customers can search and identify the laboratories accredited by NABL for their specific requirements from

  • the NABL website or
  • Directory of accredited laboratories.

The labs are required to participate in proficiency testing which is again demonstration of competence.

So, there is increased confidence in the reports released by the laboratory thus it increased the confidence.

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Benefits of Accreditation

  • Laboratories
  • Use of NABL symbol
  • International Recognition
  • Satisfaction of the staff
  • Continuous improvement
  • Systemic control of lab work
  • Benchmark with best laboratories

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Benefits of Accreditation

  • Others

It raises community confidence in the services provided by the laboratory. Finally, Accreditation provides an objective system of empanelment by insurance and other third parties.

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Accreditation Process

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THANK YOU

Prepared by -

Sohini Bera, M.Pharm , 2nd Year

Pharmaceutical Quality Assurance

Department Of Pharmaceutical Science And Technology

Birla Institute Of Technology, Mesra