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BNN40703Quality Assurance and Quality Control in Biotechnology
By: Dr. Nadirul Hasraf Mat Nayan
CHAPTER 2QUALITY MANAGEMENT,
CONTROL AND ASSURANCE
Chapter OverviewCHAPTER 2: QUALITY MANAGEMENT,
CONTROL AND ASSURANCECHAPTER 2.1: Introduction to Quality Management,
Control and Assurance
CHAPTER 2.2: The Differences Between Quality Control and Quality Assurance
CHAPTER 2.3: Quality Control and Quality Assurance in Biotechnology
CHAPTER 2.4: Current Good Manufacturing Practice (cGMP)
Chapter 2.2
The Differences Between Quality Control and Quality Assurance
Chapter OverviewCHAPTER 2.2: THE DIFFERENCES BETWEEN QUALITY CONTROL AND QUALITY ASSURANCE
CHAPTER 2.2.1: The Difference Between Quality Control and Quality Assurance: Definition
CHAPTER 2.2.2: The Difference Between Quality Control and Quality Assurance: Focus
CHAPTER 2.2.3: The Difference Between Quality Control and Quality Assurance: Goal
Chapter OverviewCHAPTER 2.2: THE DIFFERENCES BETWEEN QUALITY CONTROL AND QUALITY ASSURANCE
CHAPTER 2.2.4: The Difference Between Quality Control and Quality Assurance: How
CHAPTER 2.2.5: The Difference Between Quality Control and Quality Assurance: What
CHAPTER 2.2.6: The Difference Between Quality Control and Quality Assurance: Responsibility
Chapter OverviewCHAPTER 2.2: THE DIFFERENCES BETWEEN QUALITY CONTROL AND QUALITY ASSURANCE
CHAPTER 2.2.7: The Difference Between Quality Control and Quality Assurance: Statistical Technique
CHAPTER 2.2.8: The Difference Between Quality Control and Quality Assurance: Tool
CHAPTER 2.2.9: The Difference Between Quality Control and Quality Assurance: Example
2.2.1: The Difference Between Quality Control and Quality Assurance: Definition
DEFINITION
QUALITY CONTROL QUALITY ASSURANCEQuality control is a set of activities for ensuring quality in products.
The activities focus on identifying defects in the actual products produced.
Quality assurance is a set of activities for ensuring quality in the processes by which products are developed.
2.2.2: The Difference Between Quality Control and Quality Assurance: Focus
FOCUS ON
QUALITY CONTROL QUALITY ASSURANCEQuality control aims to identify and correct defects in the finished product.
Quality control, therefore, is a reactive process.
Quality assurance aims to prevent defects with a focus on the process used to make the product.
It is a proactive quality process.
2.2.3: The Difference Between Quality Control and Quality Assurance: Goal
GOAL
QUALITY CONTROL QUALITY ASSURANCEThe goal of quality control is to identify defects after a product is developed and before it is released.
The goal of quality assurance is to improve development and test processes, so that defects do not arise when the product is being developed.
2.2.4: The Difference Between Quality Control and Quality Assurance: How
HOW
QUALITY CONTROL QUALITY ASSURANCEFinding and eliminating sources of quality problems through tools and equipment so that customer’s requirements are continually met.
Establish a good quality management system and the assessment of its adequacy.
Periodic conformance audits of the operations of the system.
2.2.5: The Difference Between Quality Control and Quality Assurance: What
WHAT
QUALITY CONTROL QUALITY ASSURANCEThe activities or techniques used to achieve and maintain the product quality, process, and service.
Prevention of quality problems through planned and systematic activities including documentation.
2.2.6: The Difference Between Quality Control and Quality Assurance: Responsibility
RESPONSIBILITY
QUALITY CONTROL QUALITY ASSURANCE
Quality control is usually the responsibility of a specific team that tests the products for defects.
Everyone on the team involved in developing the products is responsible for quality assurance
2.2.7: The Difference Between Quality Control and Quality Assurance: Statistical Technique
STATISTICALTECHNIQUE
QUALITY CONTROL QUALITY ASSURANCEWhen statistical tools and techniques are applied to finished products (process outputs), they are called as Statistical Quality Control (SQC) and comes under quality control.
When statistical tools and techniques are applied to processes (process inputs and operational parameters), they are called Statistical Process Control (SPC) and it becomes the part of quality assurance.
2.2.8: The Difference Between Quality Control and Quality Assurance: Tool
AS A TOOL
QUALITY CONTROL QUALITY ASSURANCE
Quality control is a corrective tool.
Quality assurance is a managerial tool.
2.2.9: The Difference Between Quality Control and Quality Assurance: Example
EXAMPLE
QUALITY CONTROL QUALITY ASSURANCE
Validation and new drug substance testing is an
example of quality control.
Verification is an example of quality
assurance.
