Pharmacy, Quality Assurance, Sem- VI, B pharm

1. NABL ACCREDITATION
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2. NABL ACCREDITATION
 Laboratory studies form an important part of
assessing the quality of products.
 For test results to be accepted at national &
international levels, they must be proven to be
reliable.
 This is possible only when the systems in those
laboratories meet certain quality requirements.
 Accreditation is a quality assurance process under
which products, processes, systems, services or
operations of the laboratory organization are
evaluated by third party or by authoritative party.
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3. NABL ACCREDITATION
In India the accreditation body named as the
National Accreditation Board for Testing and
Calibration of Laboratories.
International Laboratory Accreditation Cooperation
Asia Pacific Laboratory Accreditation Cooperation
NABL
 NABL accreditation has a validity period of 2
years. The CAB must apply 6 months prior of
validity expiry for renewal of accreditation
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4. NABL ACCREDITATION
Advantages of
Accreditation: Higher level of confidence in calibration/
testing reports that the laboratory issues.
Increased business with greater
customer confidence in testing reports.
Improved control over laboratory
operations
Guarantee of reliable test results which
reduces the need of retesting.
Improved visibility in market as a good
quality service provider.
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5. NABL ACCREDITATION
Procedure for NABL Accreditation:
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Grant of Accreditation
Scrutiny and recommendation for accreditation
Corrective Action by CAB
Final Assessment Audit
Pre-Assessment Audit
Acknowledgement of application
Application for NABL Accreditation

6. PROCESS OF ACCREDITATION
INVOLVES FOLLOWING STEPS:
1. Application by CAB to NABL:
• The CAB is required to apply in the prescribed application form in
three copies along with two copies of the quality Manual of the
CAB. That should describe the management system in accordance
with ISO
• The application is to be accompanied with the prescribed
application fee and clear mention of scope of the accreditation for
which the CAB wishes to apply.
2. Acknowledgement and scrutiny of application:
• NABL Secretariat on the receipt of application form, the quality
manual and the fees issues or acknowledgement to the CAB
indicating a unique ID number which is used for correspondence
with the CAB.
• After scrutiny of application for its completeness in all respects
NABL Secretariat may ask for additional information or clarification
if necessary.
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7. 3. Pre-assessment visit by lead assessor:
• In case there are no inadequacies in the quality manual or after satisfactory
correction action by the CAB a pre-assessment visit of the CAB is
organized by lead assessor appointed by NABL.
• The lead assessor submits a pre assessment report to NABL Secretariat
with a copy of the CAB.
• The CAB makes corrective action on the non-conformities raised on the
documented management system and its implementation and submits a
report to NABL Secretariat.
4. Final assessment by assessment team:
• After the CAB has taken satisfactory corrective actions, NABL finalizes the
constitution of the assessment team in Constitution with CAB the team
includes the lead assessor and Technical assessors experts in order to
cover various fields.
• The report prepared by the assessment team is send to NABL Secretariat.
However, a copy of summary of assessment report and copies of non-
conformities If any are provided to the CAB at the end of assessment visit
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PROCESS OF ACCREDITATION
INVOLVES FOLLOWING STEPS:

8. 5. Corrective action by CAB:
• The assessment report is examined by in NABL Secretariat and follow-
up action as required is initiated.
• CAB has to take necessary corrective action on non-conformities and
submit a report to NABL Secretariat with in 60 days.
• NABL monitors the progress of the closing of non-conformities.
6. Scrutiny and recommendation for accreditation:
• After satisfactory corrective action by the CAB, the accreditation
committee examines the assessment report, additional information
received from the CAB and consequent verification If any.
• In case everything is in order the accreditation committee makes
appropriate recommendation regarding accreditation of the CAB to the
chairman NABL.
• All decisions taken by NABL are open to appeal by the CAB. The
appeal is to be addressed to director NABL.
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PROCESS OF ACCREDITATION
INVOLVES FOLLOWING STEPS:

9. 7. Grant of accreditation:
• When recommendation result in the grant of accreditation
NABL issues and accreditation certificate which has a unique
number and NABL hologram, disciplined date and validity
along with the scope of accreditation.
• The NABL accreditation certificate is valid for a period of two
year, NABL conducts annual surveillance of the CAB at
intervals of one year, which is aimed at evaluating continued
compliance to the requirement of ISO and relevant specific
criteria and NABL policies.
• The CAB has to apply 6 months before the expiry of
accreditation to allow NABL to organize the assessment of the
CAB so that the continuity of the accreditation status is
maintained.
-Pratik Terse
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PROCESS OF ACCREDITATION
INVOLVES FOLLOWING STEPS:

10. -Pratik Terse
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