El 12 de mayo de 2017 celebramos en la Fundación Ramó Areces una jornada con IS Global y Unitaid sobre enfermedades transmitidas por vectores, como la malaria, entre otras.
The document defines a Pharmaceutical Quality System (PQS) and describes the PQS implemented at the Ninewells Aseptic Dispensing Unit. A PQS is the organized system that ensures medicinal products are of the required quality. The Ninewells unit prepares 38,000 items annually using isolators and laminar flow cabinets in grade B and C rooms. Key elements of its PQS include documentation control, standard operating procedures, change control, deviation management, personnel training, internal auditing, complaints handling, and quality reviews. However, a formal validation master plan is not currently in place.
Food Safety and Quality systems have a major impact on your business including regulatory compliance, risk mitigation and operational performance. For most food companies, the expectations are high, the risk is great, but it’s not getting any easier to balance these critical areas.
In this session of our Beyond Compliance webinar and podcast series, Jeff Chilton (Vice President of Professional Services, Alchemy Systems) discusses smart, simple and realistic strategies that companies of any size can use to optimize their food safety and quality systems. Jeff provides insight from over 30 years of experience in the food industry specializing in food safety, quality assurance, and plant management.
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...TGA Australia
An overview of regulatory requirements introduced as part of the new PIC/s PE009-13 Guide to Good Manufacturing Practice, specifically outlining impact on micro laboratories. Also, a summary of the new PI041-1 Data Integrity Guidance will be provided with a particular focus of Data Integrity in the laboratory
The document discusses the International Conference on Harmonization (ICH). ICH was established in 1990 to harmonize technical requirements for pharmaceutical registration among countries in Europe, Japan and the United States. It aims to ensure safety, quality and efficacy of drugs while avoiding duplication of testing. Key ICH guidelines cover quality, safety, efficacy and multidisciplinary topics. Stability testing guidelines require evaluating drug products under different storage conditions and timepoints to determine shelf life. The harmonization process has led to over 50 guidelines streamlining pharmaceutical research and development globally.
This document provides an overview of quality assurance and related concepts in the food industry. It defines quality assurance and discusses its relationship to total quality management. Key aspects covered include good manufacturing practices (GMP), good laboratory practices (GLP), good agricultural practices (GAP), and sanitary and hygienic practices. GMP, GLP, GAP and hygienic practices all establish guidelines and procedures to ensure food safety and quality throughout the production and processing chain. Total quality management (TQM) is also discussed as a philosophy aimed at continuous improvement of quality to meet customer expectations.
The document discusses quality metrics that are used in the pharmaceutical industry to monitor quality control systems and processes. It defines three key quality metrics that the FDA intends to calculate: (1) Lot Acceptance Rate (LAR), which measures the number of accepted lots versus total lots started; (2) Invalidated Out-of-Specification Rate (IOOSR), which measures invalidated out-of-specification test results versus total out-of-specification results; and (3) Product Quality Complaint Rate (PQCR), which measures the number of quality complaints received versus total units distributed. Quality metrics are important to ensure acceptable product quality and assess performance and improvements.
The document defines a Pharmaceutical Quality System (PQS) and describes the PQS implemented at the Ninewells Aseptic Dispensing Unit. A PQS is the organized system that ensures medicinal products are of the required quality. The Ninewells unit prepares 38,000 items annually using isolators and laminar flow cabinets in grade B and C rooms. Key elements of its PQS include documentation control, standard operating procedures, change control, deviation management, personnel training, internal auditing, complaints handling, and quality reviews. However, a formal validation master plan is not currently in place.
Food Safety and Quality systems have a major impact on your business including regulatory compliance, risk mitigation and operational performance. For most food companies, the expectations are high, the risk is great, but it’s not getting any easier to balance these critical areas.
In this session of our Beyond Compliance webinar and podcast series, Jeff Chilton (Vice President of Professional Services, Alchemy Systems) discusses smart, simple and realistic strategies that companies of any size can use to optimize their food safety and quality systems. Jeff provides insight from over 30 years of experience in the food industry specializing in food safety, quality assurance, and plant management.
TGA presentation: PICS Guide for GMP and Data Integrity relating to microbiol...TGA Australia
An overview of regulatory requirements introduced as part of the new PIC/s PE009-13 Guide to Good Manufacturing Practice, specifically outlining impact on micro laboratories. Also, a summary of the new PI041-1 Data Integrity Guidance will be provided with a particular focus of Data Integrity in the laboratory
The document discusses the International Conference on Harmonization (ICH). ICH was established in 1990 to harmonize technical requirements for pharmaceutical registration among countries in Europe, Japan and the United States. It aims to ensure safety, quality and efficacy of drugs while avoiding duplication of testing. Key ICH guidelines cover quality, safety, efficacy and multidisciplinary topics. Stability testing guidelines require evaluating drug products under different storage conditions and timepoints to determine shelf life. The harmonization process has led to over 50 guidelines streamlining pharmaceutical research and development globally.
This document provides an overview of quality assurance and related concepts in the food industry. It defines quality assurance and discusses its relationship to total quality management. Key aspects covered include good manufacturing practices (GMP), good laboratory practices (GLP), good agricultural practices (GAP), and sanitary and hygienic practices. GMP, GLP, GAP and hygienic practices all establish guidelines and procedures to ensure food safety and quality throughout the production and processing chain. Total quality management (TQM) is also discussed as a philosophy aimed at continuous improvement of quality to meet customer expectations.
The document discusses quality metrics that are used in the pharmaceutical industry to monitor quality control systems and processes. It defines three key quality metrics that the FDA intends to calculate: (1) Lot Acceptance Rate (LAR), which measures the number of accepted lots versus total lots started; (2) Invalidated Out-of-Specification Rate (IOOSR), which measures invalidated out-of-specification test results versus total out-of-specification results; and (3) Product Quality Complaint Rate (PQCR), which measures the number of quality complaints received versus total units distributed. Quality metrics are important to ensure acceptable product quality and assess performance and improvements.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. It covers 7 modules and career prospects in quality assurance, control, auditing, and management are discussed. The program awards a certificate upon completion.
FDA hosted three webinars after the release of the Food Safety Modernization Act (FSMA) Final Rules on Preventive Controls. These rules will set new safety requirements for facilities that manufacture, process, pack or hold human food and animal food.
Presentation: TGA manufacturing principles update - Adoption of PIC/S Guide t...TGA Australia
TGA is adopting updates to the PIC/S Guide to GMP including PE009-13 and future revisions such as PE009-14. Key points include:
- PE009-13 was adopted on January 1, 2018 with a 12 month transition period for industry to comply.
- Future revisions will address additional chapters and annexes to further clarify requirements.
- TGA plays an active role in updating PIC/S GMP guidance to ensure risks are addressed and GMP keeps pace with innovation.
- Adopting international standards supports TGA's mutual recognition agreements and provides assurance in international markets.
This is a presentation based on ICH Q10, Pharmaceutical Quality System, It was shared recently with participants of a training session arranged by Ingrope Information Services karachi at marriot Hotel. I am uploading for the benefits of all pharma colleagues, specially the junior ones.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
The ACSS Consortium And The Generic Medicines Work-Sharing TrialTGA Australia
The document discusses the ACSS Consortium's Generic Medicines Work-Sharing Trial (GMWST). It summarizes that the ACSS Consortium allows four regulatory authorities to collaborate on reviews of generic medicines applications. The GMWST aims to complete reviews in 5 months by having one agency lead and others participate. The document describes the first application submitted under the GMWST, noting it took longer than expected but was still faster than individual reviews. It concludes the trial was successful overall and recommends expanding the program to more applications and agencies going forward.
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
The document summarizes the ICH Q10 guideline, which provides a framework for pharmaceutical quality systems throughout the lifecycle of pharmaceutical products. The guideline aims to facilitate continual improvement and quality risk management. It augments good manufacturing practices and covers topics like management responsibility, process performance monitoring, change management, and knowledge management. When combined with ICH Q8 on pharmaceutical development and ICH Q9 on quality risk management, ICH Q10 provides a harmonized approach to ensuring product quality.
Online Clinical Trial Notification (CTN)TGA Australia
A brief overview of the clinical trials environment including the role of the Clinical Trial Jurisdictional Working Group and the Framework for Action (2) Provide an update on progress over the last year on key projects (3) Outline the importance of leadership and collaboration to maintain the momentum of improvements.
Introduction of training on pharmaceutical quality system Dr.Milind Pathak
The document provides information about a training on pharmaceutical quality systems organized by Quality Circle Forum of India (QCFI). QCFI is a non-profit organization that provides training to professionals at different levels in industries. The Ankleshwar chapter of QCFI has launched activities like 6-month evening coaching and campus training programs on pharmaceutical quality systems and regulatory guidelines for pharmaceutical industries. The training modules will cover topics like cGMP, documentation, sanitation, validations, quality risk management and ICH guidelines. The training will be participatory in nature followed by an evaluation test, and certificates will be distributed. It will be conducted by Dr. Milind Pathak, who has 29 years of experience in quality assurance, quality systems and
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
Consultation on “Guidance on variations to biologicals included in the Register”TGA Australia
An overview of the open consultation on “Guidance on variations to biologicals included in the Register” including a summary of major changes from the previous version of the guidance.
Presentation: Prescription medicine registration process performanceTGA Australia
The presentation provides an update on the streamlined submission process, five years on, including the evolution of the milestone-based process from inception to the present day, and opportunities for future improvements.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. It covers 7 modules and career prospects in quality assurance, control, auditing, and management are discussed. The program awards a certificate upon completion.
FDA hosted three webinars after the release of the Food Safety Modernization Act (FSMA) Final Rules on Preventive Controls. These rules will set new safety requirements for facilities that manufacture, process, pack or hold human food and animal food.
Presentation: TGA manufacturing principles update - Adoption of PIC/S Guide t...TGA Australia
TGA is adopting updates to the PIC/S Guide to GMP including PE009-13 and future revisions such as PE009-14. Key points include:
- PE009-13 was adopted on January 1, 2018 with a 12 month transition period for industry to comply.
- Future revisions will address additional chapters and annexes to further clarify requirements.
- TGA plays an active role in updating PIC/S GMP guidance to ensure risks are addressed and GMP keeps pace with innovation.
- Adopting international standards supports TGA's mutual recognition agreements and provides assurance in international markets.
This is a presentation based on ICH Q10, Pharmaceutical Quality System, It was shared recently with participants of a training session arranged by Ingrope Information Services karachi at marriot Hotel. I am uploading for the benefits of all pharma colleagues, specially the junior ones.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
The ACSS Consortium And The Generic Medicines Work-Sharing TrialTGA Australia
The document discusses the ACSS Consortium's Generic Medicines Work-Sharing Trial (GMWST). It summarizes that the ACSS Consortium allows four regulatory authorities to collaborate on reviews of generic medicines applications. The GMWST aims to complete reviews in 5 months by having one agency lead and others participate. The document describes the first application submitted under the GMWST, noting it took longer than expected but was still faster than individual reviews. It concludes the trial was successful overall and recommends expanding the program to more applications and agencies going forward.
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
The document summarizes the ICH Q10 guideline, which provides a framework for pharmaceutical quality systems throughout the lifecycle of pharmaceutical products. The guideline aims to facilitate continual improvement and quality risk management. It augments good manufacturing practices and covers topics like management responsibility, process performance monitoring, change management, and knowledge management. When combined with ICH Q8 on pharmaceutical development and ICH Q9 on quality risk management, ICH Q10 provides a harmonized approach to ensuring product quality.
Online Clinical Trial Notification (CTN)TGA Australia
A brief overview of the clinical trials environment including the role of the Clinical Trial Jurisdictional Working Group and the Framework for Action (2) Provide an update on progress over the last year on key projects (3) Outline the importance of leadership and collaboration to maintain the momentum of improvements.
Introduction of training on pharmaceutical quality system Dr.Milind Pathak
The document provides information about a training on pharmaceutical quality systems organized by Quality Circle Forum of India (QCFI). QCFI is a non-profit organization that provides training to professionals at different levels in industries. The Ankleshwar chapter of QCFI has launched activities like 6-month evening coaching and campus training programs on pharmaceutical quality systems and regulatory guidelines for pharmaceutical industries. The training modules will cover topics like cGMP, documentation, sanitation, validations, quality risk management and ICH guidelines. The training will be participatory in nature followed by an evaluation test, and certificates will be distributed. It will be conducted by Dr. Milind Pathak, who has 29 years of experience in quality assurance, quality systems and
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
Consultation on “Guidance on variations to biologicals included in the Register”TGA Australia
An overview of the open consultation on “Guidance on variations to biologicals included in the Register” including a summary of major changes from the previous version of the guidance.
Presentation: Prescription medicine registration process performanceTGA Australia
The presentation provides an update on the streamlined submission process, five years on, including the evolution of the milestone-based process from inception to the present day, and opportunities for future improvements.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
Process validation.pptx_Process validation and inspection method with Exampl...ZerlealemTsegaye2
Process validation, definition and purpose
General principle
Traditional vs new paradigm
Risk assessment as part of process validation
Validation scheme: Monitoring and Sampling
Specific topics: Blend uniformity and validation of compression step
Process validation: other dosage forms
Process validation: sterile products
Process validation : Biological products
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List of References used
ICH Q10 GUIDELINES (PHARMACEUTICAL QUALITY SYSTEM)
- Contents
- ICH
- ICH GUIDELINES
- Objective
Q10 GUIDELINE
- Introduction
- Scope
- Objective of Q10 Guideline
- Elements
- CAPA System
- Change Management System
- Continual improvement of pharmaceutical quality system
- References
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Food safety management system Fast food restaurentkrunal solanki
The document provides details on planning, designing, and implementing a food safety management system for a concept fast food restaurant located in Lucerne, Switzerland. It outlines 7 key steps: 1) Establishing global food safety standards, 2) Assessing prerequisites, 3) Senior management implementation, 4) Implementing food safety and HACCP plans, 5) Establishing a food safety quality management system, 6) Providing training and implementation, and 7) Conducting internal auditing. The document also covers food handler training procedures, facility design including layouts for the restaurant and kitchen, guidelines for food flow, and checklists for risk factors, supplier selection, and pest control among other food safety topics.
201 regulatory aspects of drug and cosmetics .pdfBhavikaAPatel
regulatory aspects of drug and cosmetics
1. Regulatory Requirements for Registration of Drugs & Post Approval Requirements in WHO through Prequalification Program
2. FDA ORGANIZATION CHART
3. Marketing Authorization of EU for APPLICATION PROCEDURES
4. Global Countries Classification
5. Organization and structure of EMA&EDQMActive substance Master files IMPD
6. DRUG MASTER FILE in USA
Quality assurance and quality control are important functions in the pharmaceutical industry to ensure product safety, efficacy and consistency. Quality assurance aims to prevent defects through establishing quality management systems, while quality control identifies defects through analytical testing of products. Both functions work together to build quality into products and maintain compliance with Good Manufacturing Practices, which regulate manufacturing processes to minimize risks like contamination and improper dosing. Adhering to quality standards is essential for patient health and safety, as well as maintaining credibility and profitability in the pharmaceutical industry.
This document discusses Total Quality Management (TQM) in the pharmaceutical industry. TQM is a multifaceted approach that involves building quality into every step of the pharmaceutical process from research and development to manufacturing to marketing. It utilizes various quality management techniques like quality risk management, quality by design, good manufacturing practices, and ISO standards. TQM ensures quality is maintained through all stages of production from raw materials to finished drugs. It is important for the pharmaceutical industry given many drugs are life saving and quality defects could pose health hazards.
This training course provides an understanding of process validation requirements for pharmaceutical and biologic products. Participants will learn how to establish effective process validation systems and integrate them with other quality systems. They will also learn how to develop validation protocols and reports, as well as monitoring programs, to ensure critical process parameters remain in control. The course reviews validation needs for electronic systems and covers the FDA's process validation lifecycle approach.
ISO 22000 provides a standardized framework for implementing HACCP in a harmonized way across countries and food products. Implementing HACCP is a fundamental requirement of ISO 22000. There are 8 steps to implementing ISO 22000 which include nominating a food safety team, setting prerequisite programs, developing a HACCP plan, documenting procedures, training and implementation, internal auditing, management review, and optional certification.
This full day presentation gives an overview of the process validation lifecycle approach, the FDA PV Guidance, the lifecycle approach to cleaning validation, equipment qualification, and validation quality systems.
The document outlines an agenda for a validation boot camp covering the lifecycle approach to pharmaceutical validation, including an introduction to the process validation lifecycle, applications of the approach to cleaning processes and equipment qualification, implementation strategies, and opportunities for interactive discussion.
This document provides an overview of validation in the pharmaceutical industry. It defines validation as a documented program that ensures a process will consistently produce a product meeting predetermined specifications. The document discusses the importance of validation in assuring quality and reducing costs. It outlines the scope of validation, which covers all aspects influencing quality from product design to storage. Prospective, concurrent and retrospective validation approaches are described. The organization of a validation group with representatives from relevant departments is also presented.
Go deeper with athenahealth specialists to discover all that you need to know and some things you may not know about Meaningful Use Stage 2 and the newest government updates.
Contamination Control Cleaning Validation.pdfHassanHani5
This presentation discusses cleaning validation, including potential contaminants, regulatory requirements, challenges, and continuous process verification programs. It outlines the scope of a cleaning validation program, including validation plans, sampling strategies, and continued process verification. An example continuous process verification program from CSL Behring is presented, showing trend data from recent cleaning validations. The conclusion emphasizes that cleaning validation presents challenges, but robust processes supported by scientific rationale are expected by regulators to control contamination.
This document discusses pharmaceutical validation, including definitions, guidelines, and types of validation. It defines validation as providing documented evidence that a process will consistently produce a product meeting predetermined specifications. The major types of validation discussed are process validation, cleaning validation, equipment validation, and validation of analytical methods. Process validation ensures manufacturing processes can repeatedly produce quality products. It also outlines the key steps to validating specific dosage forms, including formulation development, analytical method development, process validation, stability studies, quality control testing, and documentation.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
This document discusses quality control and quality assurance in microbiological laboratory investigations. It emphasizes the importance of standard operating procedures, internal quality assessment, and external quality assessment. Quality control occurs at multiple stages of analysis, including pre-analytical (specimen collection and transport), analytical (reagents, equipment, procedures), and post-analytical (reporting and interpretation of results). A quality control officer oversees quality control in the department through regular monitoring, assessment, communication, and analysis of quality control data.
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In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Jan Kolaczinski-Enfermedades transmitidas por vectores
1. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Global Malaria Programme
Prequalification Team
Department of Control of Neglected Tropical Diseases
Overview of revised WHO evaluation
process to support introduction of
new vector control products
Bringing innovation to the front-line:
New tools to advance the global response to vector-borne diseases
11-12 May 2017, Fundación Ramón Areces, Madrid, Spain
2. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Background
• WHO process for evaluation of vector control
products has been revised: WHO Pesticide Evaluation
Scheme (WHOPES) → Prequalifications Team (PQT)
• Revised process came into effect on 1 January 2017
• Objectives are to:
1. Enable access to safe, effective and high-quality vector
control products;
2. Enhance evidence-based guidance to promote best
use and management of vector control tools,
technologies and approaches;
3. Promote product quality throughout the product’s life
cycle.
3. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Key Features
• The revised process consists of two pathways:
• Prequalification Pathway
• New Interventions Verification Pathway
• Evaluation pathway is determined by whether or not a
product is part of a product class with an existing
WHO policy recommendation
• Requirement for policy recommendation prior to
prequalification aligns process for vector control
products with that for medicines, vaccines,
diagnostics, and other medical equipment and devices
4. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Revised Evaluation Process – Pathway Determination
• Process starts when a product developer/manufacturer submits a pre-
submission package for a vector control product via single entry portal managed
by PQT
• Pre-submission Coordination Committee [PQT, GMP and NTD] reviews
application and determines pathway
• PCC provides feedback to the product developer/manufacturer on process and
requirements for WHO evaluation
• Applicant should then submit a full application as directed
5. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Revised Evaluation Process – PQT Pathway
• Applicant needs to develop full product dossier
based on the safety, efficacy, and quality
requirements as outlined in PQT-VC procedure
• Application will be screened for completeness
• Once application is complete, two parallel
activities commence:
1. Assessment of the application by experts at
the Assessment Session for Vector Control
Products (ASVCP);
2. Inspection of the manufacturing facilities to
ensure compliance with WHO-
recommended quality standards
• Decision on prequalification will be made based
on review of the submitted application and the
outcome of inspections
• Post-prequalification activities: product change
management (formulation and labelling), post
marketing surveillance, product testing, and
periodic monitoring of manufacturing sites
6. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
• Draws on Vector Control Advisory Group (VCAG)
• Product concept reviewed to determine data
required to:
a) assess new product class or claim
b) assess public health value
Public health value = proven protective efficacy to
reduce or prevent infection and/or disease in humans
• Applicant advised on data required and appropriate
trial designs
• VCAG supports development of risk assessment
framework & product specifications
• Applicant then needs to develop study protocol,
identify testing sites and generate data
• Data will be assess by VCAG & recommendation on
public health value made to WHO
• Policy recommendation & operational guidance
• PQT inspection process conducted in parallel with
data assessment, to ensure completion coincides
with publication of policy recommendation
• Product becomes eligible for prequalification
Public health value = proven protective efficacy to
reduce or prevent infection and/or disease in humans
Revised Evaluation Process – New Interventions
7. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Revised Evaluation Process
8. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Transition from WHOPES to PQT
• During transition all products with a WHOPES recommendation
(interim or full) will be given time-limited WHO prequalification
and be listed accordingly
• To ensure clarity the time-limited listing will:
specify the product’s suitability with respect to the eligibility
criteria
the claims for which it has been assessed
whether additional data are required for further product
evaluation
timeframe for the product developer to provide these data
• If data requirements are not met within the specified
timeframe, the product will be delisted.
9. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
WHO Policy Recommendation
10. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
http://www.who.int/malaria/publications/atoz/vector-control-recommendations/en/
11. Global Malaria Programme | Department of Control of Neglected Tropical Diseases | Prequalification Team
Global Malaria Programme
Prequalification Team
Department of Control of Neglected Tropical Diseases
Thank you