Lecture

Quality Assurance in Drug Development

Graph Chat

Chat with Graph Search

Ask any question about EPFL courses, lectures, exercises, research, news, etc. or try the example questions below.

DISCLAIMER: The Graph Chatbot is not programmed to provide explicit or categorical answers to your questions. Rather, it transforms your questions into API requests that are distributed across the various IT services officially administered by EPFL. Its purpose is solely to collect and recommend relevant references to content that you can explore to help you answer your questions.

Description

This lecture covers the regulatory environment for quality compliance in drug development, focusing on the role of quality and compliance in ensuring the safety, efficacy, and quality of pharmaceutical products. It discusses the main features of the European Quality Management System, including quality assurance, quality control, and good practices. The lecture also addresses the importance of documentation, the impact of health authorities inspections, and the elements of a pharmaceutical quality system. Emphasis is placed on the need for preventative measures, systematic activities, and the balance between efforts and costs in maintaining quality standards.

Official source

Related concepts (16)

Quality management

Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management.

Quality assurance

Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design.

Drug development

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.

Pharmaceutical industry

The pharmaceutical industry discovers, develops, produces, and markets pharmaceutical drugs for the use as medications to be administered to patients (or self-administered), with the aim to cure and prevent diseases, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.

Quality (business)

In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something (goods or services); it is also defined as being suitable for the intended purpose (fitness for purpose) while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace.

Related lectures (63)

Visual quality assessment

Covers the measurement and trends in assessing the quality of multimedia content, including subjective evaluation methodologies and objective quality metrics.

Quality in Healthcare

Explores the concept of quality in healthcare, emphasizing the importance of quality assurance and the challenges in implementing quality management.

Quality Management: Control and Tools

Explores quality management, costs, tools, and control processes with a focus on customer expectations and statistical tools.

Tarification of Mobility: Planning and Impacts MOOC: Mobility planning

Examines the role of tarification in mobility planning and its impact on infrastructure usage and service quality.

Process Capability: Quality Improvement