NABL

NABL .This presentation is related to the one of the topics of pharmaceutical management.

1. Nabl certification and accreditation Presented by: Sonia M.pharm(Pa & QA) Laureate institute of pharmacy

2. NABL NABL National Accreditation Board for Testing and Calibration Laboratories Under QCI of Government of India. is an autonomous body registered under Societies Act in1992

3. The international standards followed are : ISO 15189:2007 (for Medical Testing) , ISO/IEC 17025:2005 (for Testing, calibration) ISO 17043:2010 (for PT providers)

4. ILAC – International laboratory accreditation cooperation. APLAC – Asia pacific laboratory accreditation cooperation. MRA – Mutual Recognition Agreement IAF : INTERNATIONAL ACCREDITATION FORUM

5. Nabl NABL ,as an accreditation body, operates its own system as per ISO/IEC 17011 . NABL is signatory to APLAC / ILAC Mutual Recognition Arrangements (MRA) since 2000 after its first evaluation by APLAC . Second & Third evaluation by APLAC in 2004 & 2008 respectively. Fourth evaluation Completed in Sep. 2012 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.

6. Accreditation accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests/ measurements, based on third party assessment and following international standard. General requirements for laboratories or other organizations, to be considered competent to carry out sampling, testing including Diagnostic Radiology QA Testing and Software & IT System testing (o ther than medical) and calibration are specified in the International Standard ISO/IEC 17025:2005 or ISO/IEC 17025:2017.l Scope of NABL Accreditation : Testing laboratories Calibration laboratories Medical laboratories

7. Benefits of Accreditation Customers can search laboratories: Customers can search and identify the laboratories accredited by NABL for their specific requirements from the NABL website or Directory of accredited laboratories. Increased confidence in reports. The customers get services by credential staff. Savings in terms of time and money as it reduces or eliminates the need of re-testing.

8. Continuous improvement :Accreditation to laboratory stimulates continuous improvement .It enables the laboratory in demonstrating commitment to quality test reports. Systematic Control of lab work: Better control of laboratory operations and feedback to laboratories. Benchmark with best laboratorie s : It also provides opportunity to the laboratory to benchmark with the best

9. Scope of NABL Accreditation : 1) Testing Laboratories Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non-Destructive Testing Optical and Photometry Radiological Thermal Forensic

10. 2) Calibration Laboratories Electro-Technical Mechanical Radiological Thermal Optical Fluid-Flow

11. 3) Medical Laboratories Clinical Biochemistry Clinical Pathology Genetics Cytopathology Hematology & Immuno-haematology Histopathology Microbiology& Serology Nuclear Medicine (only in-vitro tests)

12. Other accreditations PROFICIENCY TESTING PROVIDERS (PTP) Testing Calibration Medical Inspection MATERIAL PRODUCERS (RMP) Chemical Composition
Biological & Clinical Properties
Physical Properties
Engineering Properties
Miscellaneous Properties

13. Preparation of CAB before applying for NABL Accreditation Appoint quality manager who has done “Internal Auditor Course as per ISO:15189:2012.”
Designate QM, TM & LD
EQAS & IQC for all parameters
Prepare quality manual and quality system manual
Preparing SOP and WDI related to different process
Training for all laboratory personnel.

14. Accreditation Procedure

15. 1) Application for Accreditation CABs are required to apply through NABL Web Portal ( www.nabl-india.org ) to NABL in prescribed application form : NABL 151, NABL 152, NABL 153 : for Testing/ Calibration Laboratories . NABL 156 : Medical Imaging- Conformity Assessment Body (MI-CAB) . NABL 180 and NABL 190 : Proficiency Testing Providers & Reference Material Producers NABL 100 : application fee

16. 2)Acknowledgement and Registration of Application NABL Secretariat send an acknowledgement with a unique ID number to the CAB on receipt of online application form along with Management system document / quality manual and the fees,.

17. 3)Appointment of Lead Assessor NABL secretariat appoints a Lead assessor from the list of empanelled assessors. The lead assessor does the document review on behalf of NABL and submits the report to NABL secretariat.

18. 4)Document Review The preliminary document review of the application and management system document/ quality manual submitted by the CAB is carried out by NABL Secretariat . Detailed review is carried out by Lead Assessor.

19. 5)Pre-Assessment Pre –assessment of the CAB is conducted by lead assessor appointed by NABL. Since Pre-assessment is optional, CAB shall express its willingness in writing to undergo the same. The pre-assessment of the CAB is conducted to: Evaluate non-conformities (if any) in the implementation of the quality system. Assess the degree of preparedness of the CAB for the assessment Determine the number of assessors required in various fields based on the scope of accreditation, number of key locations to be visited etc.

20. 6) Assessment NABL proposes constitution of an assessment team. The team includes the lead assessor , the technical assessors/ experts in order to cover various fields within the scope of accreditation sought. NABL seeks CAB’s acceptance for the proposed assessment team and the CAB is free not to accept one or more members of the proposed assessment team by giving specific reason for their non –acceptance. NABL fixes dates for on-site assessment in consultation with the CAB,

21. The documented Management system, SOPs, work instructions, test methods etc. are assessed for their effectiveness. The CAB’s technical competence to perform specific tasks is also evaluated. The assessment report contains the evaluation of technical manpower, all relevant material examined, test witnessed including those of replicate testing/ measurement, compliance to ISO/ IEC guidelines. Assessment report. also provides a recommendation towards grant of accreditation or otherwise. Assessment report prepared by the assessment team is sent to NABL Secretariat.

22. 7)Scrutiny of Assessment Report The assessment report is examined by NABL Secretariat and follow up action as required is initiated. CAB has to take necessary corrective action on non – conformities/ concerns and submit a report to NABL Secretariat within 30 days. NABL monitors the progress of closing of non –conformities.

23. 8)Accreditation Committee The Accreditation Committee examines the assessment report, additional information received from the CAB . In case the Accreditation Committee finds deficiencies in the assessment report, the NABL Secretariat obtains clarification from the Lead Assessor/ Assessor/ CAB concerned. He Accreditation Committee makes appropriate recommendations regarding accreditation of the CAB to the Chairman, NABL. All decisions taken by NABL regarding grant of accreditation are open to appeal by the CAB the appeal is to be addressed to the CEO, NABL.

24. 9)Issue of Accreditation Certificate When the recommendation results in the grant of accreditation, NABL issues an accreditation certificate which has a unique number and QR Code, discipline, date of validity along with the scope of accreditation.

25. SURVEILLANCE & RE-ASSESSMENT The Accreditation is valid for the period of 2 years.
NABL conducts an annual Surveillance of the accredited laboratories.
The laboratory must apply for renewal of accreditation at least six months before the expiry of validity of accreditation.
A Re-assessment is similar to the final Assessment and is conducted before the expiry of Accreditation.

26. Thank you