NABL by 2022820289.pptx fgjchghjtdgkfhItai

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1. QUALITY MANAGEMENT SYSTEMS: NABL A class presentation BY ABDURRAHMAN MUDASSIR (2022820289)

2. Content Introduction Importance of NABL  NABL accreditation process NABL and ISO/IEC standards NABL Vs Non-NABL accredited labs NABL and regulatory bodies Challenges in NABL accreditation NABL and B. Pharma graduates Conclusion Reference.

3. Introduction Quality Management System (QMS): is a formalized set of processes, policies and procedures an organization uses to ensure customer satisfaction and regulation compliance of its products and services. National Accreditation Board for Testing and Calibration Laboratories (NABL): An autonomous body under Quality Council of India (QCI) established to provide accreditation to;       -Testing Laboratories           -Calibration Laboratories           -Medical Laboratories           -Proficiency Testing Providers           -Reference Material Producers.              

4. Importance of NABL Ensures technical competence of labs Promotes international recognition of Indian labs Supports standardization and reliable test results Helps implement ISO/IEC 17025 and ISO 15189 standards Essential in pharmaceutical product quality control Ensures accurate testing of drugs and raw materials Boosts confidence in clinical trial and analytical data.

5. NABL Accreditation Process Application Submission Document Review Pre-assessment Audit Final Assessment Corrective Actions Accreditation Decision Surveillance & Renewal.

6. NABL and ISO/IEC Standards ISO/IEC 17025: General requirements for competence of testing/calibration labs ISO 15189: For medical laboratories           NABL ensures implementation of these standards on the following focus areas:       - Personnel qualification       - Equipment calibration       - SOPs and documentation       -  Traceability of measurements.

7. NABL vs. Non-NABL Accredited Labs FEATURE NABL ACCREDITED NON-NABL ACCREDITED -Standard Compliance Yes (ISO 17025) No -Credibility of Reports High Limited -Regulatory Acceptance Global Limited -Audits and Reviews Regular May be absent

8. NABL and Regulatory Bodies NABL works in alignment with;         - CDSCO (Central Drugs Standard Control Organization)         - WHO-GMP         - USFDA / EUGMP audits NABL data is accepted in international markets under ILAC MRA (International Laboratory Accreditation Cooperation Mutual Recognition Arrangement): an international agreement that enables acceptance of test, calibration and inspection results from accredited laboratories across participating countries.

9. Challenges in NABL Accreditation

10. NABL and B. Pharm Graduates It offers career opportunities such as: QMS Officer QA/QC Analyst in NABL-accredited labs Auditor (after experience/training) It serves as the foundation for higher studies in pharmaceutical regulatory affairs.

11. Conclusion NABL is essential for quality assurance in pharmacy Ensures compliance, competence, and credibility Builds trust in testing and analytical data A key component of global pharmaceutical standards.

12. Reference NABL Official Website: www.nabl-india.org ISO/IEC 17025 documentation CDSCO guidelines Regulatory affairs from Wikipedia: https://en.wikipedia.org/wiki/Regulatory_affairs  

13. Thank You .