EXCLUSIVELY FOR B.PHARM 6TH SEM AS PER PCI SYLLABUS

1. TOPIC: NABL- ACCREDITATION
BY
Mr.DIPANKAR NATH.
M.PHARM(PHARM.CHEMISTRY),GATE(2009),GPAT(2011)
ASSISTANT PROFESSOR.
DEPARTAMENT OF PHARMACEUTICALANALYSIS .
HIMALAYAN PHARMACY INSTITUTE,MAJHITAR,EAST SIKKIM.

2. QCI-QUALITY COUNCIL OF INDIA
 QCI is governed by a Council of 38 members with equal representations of government,
industry and consumers.
 Chairman of QCI is appointed by the Prime Minister's office on recommendation of the
government and industry.
 Council is the apex level body responsible for formulating the strategy, general policy,
constitution and monitoring of various components of QCI with objective to ensure
transparent and credible accreditation system
 Each Board functions independently with its own Chairperson appointed by the QCI
Chairman and with the members representing various stakeholders
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4. NABL-NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION
LABORATORIES.
 NABL is an autonomous society registered under Societies Act in1992 providing
Accreditation (Recognition) of Technical competence of a testing, calibration, medical
laboratory & Proficiency testing provider (PTP) & Reference Material Producer (RMP).
 NABL is an autonomous body under the aegis of Department of Science & Technology,
Government of India, and is registered under the Societies Act. It is only one of its kinds that
assess laboratories in India for quality and consistency in the results.
 NABL has agreements with ILAC (International Laboratory Accreditation Conference) and
APLAC (Asia Pacific Laboratory Accreditation Cooperation).These are especially valuable
for International recognition and mutual acceptance of test results. In short accreditation has
worldwide acceptance
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5.  NABL has been established with the objective to provide Government, Industry and society
in general with a scheme for a third party assessment of the quality and technical acceptance
of testing and calibration laboratories .
 Government of India has authorized NABL as the sole accreditation body for testing and
calibration laboratories.
 NABL provides laboratory accreditation services to laboratories that are performing
tests/Calibrations in accordance with NABL criteria based on internationally accepted
standard for laboratory accreditation ISO/IEC 17025.These services are offered in a non-
discriminatory manner and are accessible to all testing and calibration laboratories in India
and abroad regardless of their ownership, legal status, size and degree of independence.
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6. 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/IEC 17025:2005 (for Testing, calibration)
 ISO 17043:2010 (for Proficiency testing providers)
 The laboratories should be legally identifiable and appropriately registered .
 They can be part of a big organization or an independent entity.
 NABL accreditation is currently given in the following fields
 Testing laboratories
 Calibration laboratories
 Medical laboratories
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8. BENEFITS OF ACCREDITATION
Formal recognition of competence of a laboratory by an Accreditation body in accordance with
international criteria has many advantages:
1. Increased confidence in Testing/ Calibration Reports issued by the laboratory
2. Better control of laboratory operations and feedback to laboratories as to whether they have
sound Quality Assurance System and are technically competent
3. Potential increase in business due to enhanced customer confidence and satisfaction.
4. Customers can search and identify the laboratories accredited by NABL for their specific
requirements from the NABL Web-site or Directory of Accredited Laboratories
5. Users of accredited laboratories enjoy greater access for their products, in both domestic and
international markets.
6. Savings in terms of time and money due to reduction or elimination of the need for retesting of
products
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9. ACCREDITATION PROCESS:
1.An applicant laboratory is expected to submit to NABL 5 copies of the application and 5
copies of the quality manual.
2.The quality manual will be forwarded by NABL to the lead Assessor to judge adequacy of
the quality manual as to whether it is compliance with ISO 15189 standards.
3.Thereafter lead accessor will conduct a Pre-assesment report of the laboratory for one day.
Based on the Pre-assessment report the laboratory may have to take certain corrective actions
,so as to be fully prepared for the final assessment .
4.It is essential for the applicant as well as accredited laboratories to satisfactorily participate
in Proficiency testing/ Interlaboratory Comparison/External quality assessment programme as
Asia Pacific Laboratory Accreditation Cooperation(APLAC)Mutual recognition Arrangement
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10. calls for mandatory participation in such programmes.
5.Finally the laboratory is ready, the Lead Assessor and a team of technical assessors will
conduct the final assessment. The number of technical assessors will depend on the number of
discipline applied for.
6.The accreditation process involves a through assessment of all elements of the laboratory that
contribute to the production of accurate and reliable test data. These elements include Staffing,
training, supervision, quality control, equipment, recording and reporting of test results and the
environment in which the laboratory operates.
7. The laboratory may have to take certain corrective actions after final assessment. After
satisfactory corrective actions are taken by the laboratory (within a period of 3 months),the
accreditation committee will examine the report and if satisfied recommend accreditation.
8.The time required for the process of accreditation will depend upon the preparedness of the
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11. laboratory and its response to the non-conformances raised during the preassesment and final
assessment. The total duration ranges between 6-8 months.
9.Surveillance and Re-assessment Accreditation to a laboratory shall be valid for a period of 3
years. NABL should conduct annual surveillance of the accredited laboratories. The
laboratories may enhance or reduce the scope of accreditation during surveillance.
10.The laboratories need to apply for renewal of accreditation atlesat 6 months before the
expiry of validity of accreditation for which re-assessment shall be conducted
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12. 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
Certification does not make any statement
about the technical competence of the
laboratory
Uses criteria specifically developed to
determine technical competence of the
laboratory
Example- ISO 9001:2005 Certification Example –ISO 17025 Accreditation
CERTIFICATION VS ACCREDITATION
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