Quality of Pharmaceutical Products
Part 1: QA vs QA
 Quality is an important factor
 All manufacturers constantly look for enhancing their product
quality
 In order to maintain or enhance the quality of the products,
manufacturers use two techniques, Quality Control and Quality
Assurance
 These two practices make sure that the end product meets the
quality requirements and standards defined for the product
Quality of Pharmaceutical Products
Are QA and QC same terms?
Quality Control vs Quality Assurance
Definition
Focus on
Goal
How to Achieve
Example
Responsibility
Quality Control vs Quality Assurance
QA is a set of activities for ensuring
quality in the processes by which
products are developed
QC is a set of activities for ensuring
quality in products. The activities
focus on identifying defects in the
actual products produced
Definition for QA
Quality Control vs Quality Assurance
Definition for QC
Quality Control vs Quality Assurance
QA is process oriented and
focuses on defect prevention
QC is product oriented and focuses
on defect identification
QA Focus QC Focus
QA aims to prevent defects with a
focus on the process used to make the
product. It is a proactive process
It identifies weakness in processes to
improve them
QC aims to identify (and correct)
defects in the finished product.
It is a reactive process
Quality Control vs Quality Assurance
The goal of QA is to improve
development and test processes
so that defects do not occur when
the product is being developed
The goal of QC is to identify
defects after a product is
developed and before it's released
Goal
Quality Control vs Quality Assurance
Statistical Tools & Techniques can be
applied in both QA & QC. When they
are applied to processes (process
inputs & operational parameters),
they are called Statistical Process
Control (SPC); & it becomes the
part of QA
When statistical tools & techniques
are applied to finished products
(process outputs), they are called
as Statistical Quality Control
(SQC) & comes under QC
Statistical Techniques:
Quality Control vs Quality Assurance
Prevention of quality problems through
planned and systematic activities
including documentation
The activities or techniques used to
achieve and maintain the product
quality, process and service
How to achieve Quality
Quality Control vs Quality Assurance
Establish a good quality
management system and the
assessment of its adequacy &
conformance audit of the operation
system & the review of the system
itself
Finding & eliminating sources
of quality problems through
tools & equipment so that
customer's requirements are
continually met
How to achieve Quality
Quality Control vs Quality Assurance
QA
 Investigating out of specification
(OOS) test results
 Quality Assessment
 Quality Improvement
 Customer Complaint Investigation
 Audits & document review
QC
 Sampling of raw materials
 In-process testing
 Quality testing of finished
products
 Preparation/set-up of testing
equipment
 Equipment calibration
Examples
Everyone on the team involved
in developing the product is
responsible for quality
assurance
Quality control is usually the
responsibility of a specific
team that tests the product
for defects
Responsibility
Quality Control vs Quality Assurance
In Summary…..
 Quality control is about adherence to specific requirements
of the product being developed
 Quality assurance is about quality in the processes by which
products are developed
 Quality assurance activities are determined before production
work begins and these activities are performed while the
product is being developed
 Quality control activities are performed after the product is
developed
How Do We Achieve Quality ?
 QA and QC are working together
QA QC

QA vs QC

  • 1.
    Quality of PharmaceuticalProducts Part 1: QA vs QA
  • 2.
     Quality isan important factor  All manufacturers constantly look for enhancing their product quality  In order to maintain or enhance the quality of the products, manufacturers use two techniques, Quality Control and Quality Assurance  These two practices make sure that the end product meets the quality requirements and standards defined for the product Quality of Pharmaceutical Products
  • 3.
    Are QA andQC same terms? Quality Control vs Quality Assurance
  • 4.
    Definition Focus on Goal How toAchieve Example Responsibility Quality Control vs Quality Assurance
  • 5.
    QA is aset of activities for ensuring quality in the processes by which products are developed QC is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced Definition for QA Quality Control vs Quality Assurance Definition for QC
  • 6.
    Quality Control vsQuality Assurance QA is process oriented and focuses on defect prevention QC is product oriented and focuses on defect identification QA Focus QC Focus
  • 7.
    QA aims toprevent defects with a focus on the process used to make the product. It is a proactive process It identifies weakness in processes to improve them QC aims to identify (and correct) defects in the finished product. It is a reactive process Quality Control vs Quality Assurance
  • 8.
    The goal ofQA is to improve development and test processes so that defects do not occur when the product is being developed The goal of QC is to identify defects after a product is developed and before it's released Goal Quality Control vs Quality Assurance
  • 9.
    Statistical Tools &Techniques can be applied in both QA & QC. When they are applied to processes (process inputs & operational parameters), they are called Statistical Process Control (SPC); & it becomes the part of QA When statistical tools & techniques are applied to finished products (process outputs), they are called as Statistical Quality Control (SQC) & comes under QC Statistical Techniques: Quality Control vs Quality Assurance
  • 10.
    Prevention of qualityproblems through planned and systematic activities including documentation The activities or techniques used to achieve and maintain the product quality, process and service How to achieve Quality Quality Control vs Quality Assurance
  • 11.
    Establish a goodquality management system and the assessment of its adequacy & conformance audit of the operation system & the review of the system itself Finding & eliminating sources of quality problems through tools & equipment so that customer's requirements are continually met How to achieve Quality Quality Control vs Quality Assurance
  • 12.
    QA  Investigating outof specification (OOS) test results  Quality Assessment  Quality Improvement  Customer Complaint Investigation  Audits & document review QC  Sampling of raw materials  In-process testing  Quality testing of finished products  Preparation/set-up of testing equipment  Equipment calibration Examples
  • 13.
    Everyone on theteam involved in developing the product is responsible for quality assurance Quality control is usually the responsibility of a specific team that tests the product for defects Responsibility Quality Control vs Quality Assurance
  • 14.
    In Summary…..  Qualitycontrol is about adherence to specific requirements of the product being developed  Quality assurance is about quality in the processes by which products are developed  Quality assurance activities are determined before production work begins and these activities are performed while the product is being developed  Quality control activities are performed after the product is developed
  • 15.
    How Do WeAchieve Quality ?  QA and QC are working together QA QC

Editor's Notes

  • #5 Let's differentiate according to below points:  Definition  Focus on  Goal  How to Achieve  Example  Responsibility