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Notes | NABL – Testing and Calibration Laboratory B.Pharmacy Quality Assurance

NATIONAL ACCREDITATION BOARD FOR TESTING & CALIBRATIONLABORATORIES (NABL) 

 NATIONAL ACCREDITATION BOARD FOR TESTING & CALIBRATIONLABORATORIES (NABL) National Accreditation Board for Testing and Calibration Laboratories (NABL) is the sole Laboratory Accreditation body authorised by Government of India (COD).  NABL is an autonomous body under the aegis of Department of Science & Technology (COD).  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.  This developing system of international mutual recognition agreements between accreditation bodies has enabled accredited laboratories to achieve a form of international recognition, and allowed test data accompanying exported goods to be readily accepted on overseas markets amongst the countries which have already qualified as significant to ILAC Arrangements.FUNCTIONS  To promote the development and maintenance of good practice in testing and measuring  To establish and maintain international recognition for its national accreditation programmesBENEFITS  National and international recognition  Public and industry acceptance  Assurance to clients of good laboratory practice  Provides global equivalence  Provides comparability in measurements  Decision makers can rely on test results  Improves staff motivation  Ensures better support in the event of legal challenge  Saves money by getting it right at first time.PROCEDURE FOR ACCREDITATION Accreditation Process An applicant laboratory is expected to submit to NABL 5 copies of the application and 5 copies of Quality Manual.  The Quality Manual will be forwarded by NABL to a Lead Assessor to judge the adequacy of the Quality Manual as to whether it is in compliance with ISO 15189 standards.  Thereafter the Lead Assessor will conduct a PreAssessment 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.  It is essential for the applicant as well as accredited laboratories to satisfactorily participate in Proficiency testing/ Interlaboratory comparisons/External quality assessment programme as Asia Pacific Laboratory Accreditation Cooperation (APLAC) Mutual Recognition Arrangement calls for mandatory participation in such programmes.PROCEDURE FOR ACCREDITATION  Finally when 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 disciplines applied for. The accreditation process involves a thorough assessment of all the 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. The laboratory may have to take certain corrective actions, after the 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.PROCEDURE FOR ACCREDITATION The time required for the process of accreditation will depend upon the preparedness of the laboratory and its response to the non-conformances raised during the pre-assessment and final assessment. The total duration ranges between 6 and 8 months. Surveillance and Re-Assessment Accreditation to a laboratory shall be valid for a period of three years. NABL shall conduct annual surveillance of the accredited laboratories.  The laboratories may enhance or reduce the scope of accreditation during surveillance. The laboratories need to apply for renewal of accreditation, at least six months before the expiry of validity of accreditation for which a re-assessmentThank You

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