Cm2 principles of qa
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1. The document discusses principles of quality assurance in laboratory testing. It defines quality assurance as the overall program that ensures correct test results are delivered to the right person on time. 2. Quality control refers to measures taken during each test to ensure results are accurate and precise. This includes analyzing controls to verify the test is working properly. 3. Quality assessment involves external evaluation of a laboratory's performance through proficiency testing, allowing assessment of the effectiveness of the quality assurance and quality control programs.
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The document discusses three key principles of clinical laboratory quality: quality, quality control, and total quality management. It describes the importance of quality control procedures to monitor performance across the total testing process, including pre-analytical and post-analytical phases. The document also outlines the different steps in laboratory testing and potential sources of errors at each step, from test ordering to specimen acquisition to analytical measurement to reporting and interpretation. It emphasizes the role of quality assurance programs in ensuring technical competence and controlling variables.
Qualitycontrolinclinicallaboratory
The issue of laboratory quality has evolved over more than 4 decades since the 1st recommendation for quality control were published in 1965
Now, quality control is seen as only one part of a total laboratory control program
Quality also includes:
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Quality control, or QC for short, is a process by which entities review the quality of all factors involved in the production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements"
This presentation gives a brief idea of Quality control and how to execute it.
Good Laboratory Practice ppt
Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment. GLP is also required for registration purpose and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products.
Pankaj resume 16-12-14
Pankaj Kumar Singh is seeking a senior role in quality assurance and regulatory compliance in the pharmaceutical industry, with over 10 years of experience in quality control operations. He currently works as an Assistant Manager of Quality Control at Macleods Pharmaceuticals, where he handles cGMP audits, incident investigations, and ensuring regulatory compliance. He has a M.Sc. in Chemistry and is proficient in quality control testing, documentation, auditing processes, and maintaining compliance with various regulatory bodies.
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In manufacturing operations, production management includes responsibility for product and process design, planning and control issues involving capacity and ...
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QC_CV
- Venketesh is seeking a leadership role in quality control and has over 13 years of experience in quality control, analytical research, regulatory audits, and ensuring compliance for APIs and finished drug products.
- He currently works as the Quality Control and R&D Manager for SM Pharmaceuticals in Malaysia, where he manages a staff of 35 people and is responsible for various quality control and analytical functions.
- Venketesh has strong skills in analytical method validations and transfers, instrument qualifications, regulatory compliance, and managing quality control laboratories and teams.
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Quality Control and Quality Assurance to check the quality and efficacy of different products like pharmaceutical or any other product
Qc and qa
Quality control and quality assurance are important for ensuring accurate lab results. Quality control involves regularly testing controls of known values to monitor a test's performance. Key quality control statistics include the mean and standard deviation, which are used to calculate control limits on a Levey-Jennings chart. Westgard rules provide standards for determining when a test is out of control based on control values. Quality assurance encompasses the overall programs and procedures that a lab follows to ensure accurate and reliable results. It has strategic, tactical, and operational levels.
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Quality.pptx
Quality refers to doing things right the first time according to established requirements and standards. It involves accuracy, reliability, and timeliness of laboratory test results. Quality control monitors performance against standards, quality assurance refers to all operational aspects, and quality management involves determining policy objectives and implementing quality planning, control, and improvement. Laboratory accreditation in India is administered by the National Accreditation Board for Testing and Calibration Laboratories (NABL) based on the ISO 15189 standard, which specifies requirements for quality and competence in medical laboratories. The quality management system involves establishing essential elements like organization, customer focus, facilities management, and processes to assure quality.
The ISO 17025 standard: principles and management requirements
The ISO 17025 standard: principles and management requirementsEU Water Initiative plus for Eastern Partnership
The ISO 17025 standard: principles and management requirements
Workshop on laboratory basics and fundamentals of ISO Quality Management Standards
March 21-22, 2018, Kyiv, UkraineConcept of glp
The document defines Good Laboratory Practice (GLP) and describes its key principles and objectives. GLP provides a framework for conducting non-clinical health and environmental safety studies to ensure reliability and reproducibility. The main elements of GLP include qualified personnel, adequate facilities and equipment, standard operating procedures, test and control article handling, and documentation and record keeping. GLP aims to assure accurate study results and promote international acceptance of safety tests.
ISO 17025 – technical requirements
ISO 17025 – technical requirements
Workshop on laboratory basics and fundamentals of ISO Quality Management Standards
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daada Quality control
this lecturer prepared by your dear brother Abdulkadir Ahmed Mo'alin known as daada please read carefully
A Step-by-Step Guide for Method Validation
What is Validation?
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry
Validation is a process-risk will determine the effort
High Risk:Total validation
Moderate Risk:Testing,Documentation
Low Risk:Testing the change
Validation of Analytical Methods-Key Steps
Preparation
Experimentation
Transfering Method
Documentation
Step 1- Preparation
Develop validation project plan
Define purpose/scope of method (performance criteria)
Define and verify performance of equipment
Qualify/validate materials
Qualify/train operator
Step 2- Experimentation
Perform validation experiments- may have to change either equipment or limits
Develop SOPs for executing the method in routine
Define type and frequency of system suitability tests and/or analytical quality control (AQC) checks
Define change control procedure
Document validation experiments and results
Step 3- Transferring Methods to Routine Laboratories
Designate project owner
Develop procedure on how to use method
Develop system suitability tests (test procedure, frequency, acceptance criteria)
Define transfer tests and acceptance criteria in the routine
Train routine lab analyst in development lab
Repeat 2 critical method validation tests in routine lab
Analyze at least three samples in development and routine lab
Analyst in routine lab should give frequent feedback
Step 4- Documentation for the FDA
Validation report and supporting documentation:
Objective, scope
Methodology
Materials
Equipment
Validation data
Supporting documentation (chromatograms, spectra)
Transfer to routine protocol
Reference to SOP
Want to learn more about analytical method validation, FDA and ICH requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:
ICH, FDA and USP Requirements for Method Validation
How to Validate Analytical Methods and Procedures
Validation of Analytical Methods and Procedures
Eliminate the Confusion - Analytical Method Qualification and Validation
Lifecycle Approach to Analytical Methods with QbD Elements
Analytical Instrument Qualification and System Validation
Lifecycle Approach to Analytical Methods for Drug Products
For more details:http://www.complianceonline.com/validation-of-analytical-methods-and-procedures-webinar-training-701615-prdw?channel=valppt
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- 2. Outline 1. Variables that affect quality of result 2. Quality assurance 1. Quality control 3. Quality assessment
- 3. Variables that affect the quality of results • The educational background and training of the laboratory personnel • The condition of the specimens (from collection/receiving – processing – assaying) • The controls used in the test runs • The interpretation of the results • The transcription of results • The reporting of results
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