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INSTRUMENT AND TEST METHOD VALIDATION DR DEEPAK SANGHAVI DOCTOR INCHARGE IMMUNOCHEMISTRY METROPOLIS HEALTHCARE LTD
INSTRUMENT INSTALLATION QUALIFICATION (IQ) DONE BY COMPANY ENGINEERS SPACE ELECTRICITY POINTS VOLTAGES KITS AVAILBLITY CERTIFICATE CE APPROVED
OPERATIONAL QUALIFICATION (PQ) DONE BY ENGINEERS WITH HELP OF TECHINICANS WATER QUALITY CUVETTES TEMPERATURE SOFTWARE CHECK
PERFORMANCE QUALIFICATION (PQ) DONE BY TECHINICANS CALIBRATION CONTROL RUNNING OF TEST VALIDATION OF TEST RESULTS QC CHECK VALIDATION DONE BY QA DEPT AND DIRECTOR OF LAB
TEST METHOD VAILDATION ACCURACY – BIAS % PRECISION – Cv % Intraassay Interassay Reproducilblity RANGE LIMIT OF DETECTION LINEARITY SPECIFICITY ROBUSTENESS
Why do we need to do it? What are the basic tools?
VALIDATIONS: TOWARDS RELAIBLE QUALITY OUTCOMES DR. SHIVPRAKASH MANAGING DIRECTOR SYNCHRON RESEARCH SERVICES PVT. LTD., INDIA.
MPA requirements on validation of bioanalytical methods The analytical method should be validated before analysing of specimens from GLP and GCP studies.
Validation Validation: A systematic study which ensures that systems, facilities and processes are working adequetly and precisely. Validation is an integral.
EQUIPMENT VALIDATION User Requirement Specification Functional Specification Design Qualification Performance Qualification Operational Qualification.
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5. Quality Assurance and Calibration Quality assurance is We do to get the right answer for our purpose. Have Sufficient accuracy and precision to support.
Routine viral diagnostics: indirect and direct detection of viruses. ◦ Indirect detection: serological tests; ◦ Direct detection: Viral antigens;
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© WHO – PSM Validations –part 5 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm.
Method Comparison A method comparison is done when: A lab is considering performing an assay they have not performed previously or Performing an assay.
1 Importance of Instrument Validation for Accredited Food Export Testing Labs.
LECTURE 13 QUALITY ASSURANCE METHOD VALIDATION. QUALITY ASSURANCE A system of activities whose purpose is to provide to the producer or the user of a.
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W W W. Q I A G E N. C O M Dirk Heckel, PhD Diagnostic Sample Preparation and Stabilization QIAGEN GmbH.
1 Dec. 8, 1997 LEADS Quality Assurance Summary Robert Brewer (512) Monitoring Operations Division Network QA Manager.
A Seminar on 1. Validation vs Qualification Why to validate? Who should do Equipment Validation? Parts of Equipment Validation Validation of.
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© SSER Ltd. How Science Works Selecting & Using Apparatus.
Remember Chemistry panel Quality Control:- In a medical laboratory, it is a statistical process used to monitor and evaluate the analytical process.
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Validation | Slide 1 of 27 August 2006 Validation Supplementary Training Modules on Good Manufacturing Practice WHO Technical Report Series, No. 937, 2006.
TO ERR IS HUMAN ……. We detest it. We avoid even talking about it. ERRORS.
Technical requirements Sampling Analysis Reporting of the results.
Module 1,, Part 4: QC-related validation Slide 1 of 28 © WHO – EDM – 1/2002 Validation Part 4: QC-related validation Supplementary Training Modules on.
LECTURER PROF.Dr. DEMIR BAYKA AUTOMOTIVE ENGINEERING LABORATORY I.
What is Instrumentation? Seth Price Department of Chemical Engineering New Mexico Tech Rev. 1/6/16.
Module 4, Inspecting the QC Laboratory Slide 1 of 15 © WHO – EDM Inspecting the QC Laboratory Supplementary Training Modules on Good Manufacturing Practice.
ANALYSI Web: ANALYSIS LTD Gandijeva 76A Novi Beograd tel/fax:
Interplay: Science - Society Fitch, Alanah, Yunlong Wang, Sean Mellican, and Susan Macha: Lead Lab Teaching Instrumentation with One Analyte. Analytical.
1 The world leader in serving science Proprietary & Confidential Sparking Performance in Metals Analysis ARL iSpark TM Series OES Metals Analyzers Innovative.
Qualification and Validation Basic Principles of GMP.
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Automated CBC Parameters and Quality Control. The Automated Complete Blood Count Most common test in the Hematology lab. Main Components of the CBC: –
An Overview. Quality Assurance: QA is defined as the overall program that ensures the final results reported by the laboratory are correct. QA is.
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A seminar On Validation Of Ampoule Filling & Sealing Machine Department Of Quality Assurance Maliba Pharmacy College 7 August
Electronic Measure and Test Unit 53 Task 4 (P4). A plan that clearly details the tests that will be performed What to test How to test (step by.
PRODUCT OVERVIEW PORTABLE INSTRUMENTS.
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Water | Slide 1 of Water for Pharmaceutical Use Part 3: Operational considerations Supplementary Training Modules on Good Manufacturing Practice.
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© WHO – PSM Quality Control Laboratory Pharmaceutical Quality, Good manufacturing Practice & Bioequivalence Kiev, Ukraine October 2005 Maija Hietava.
Improve Accuracy with Software: S 0 Calibration. Calibrating the System Plot Draw the best straight line fit for the above function –You can find the.
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