Quality Assurance

1. Sukria Hossain (2016063672)
Presentation on-
Quality Assurance

2. Contents
 Definition of Quality Assurance
 QA vs. QC
 Development of The Concept of
Quality Assurance
 Factors Affecting Product Quality
 Components of Quality Assurance
 QA Framework
 Setting up QA System
 Features of QA System
 The Quality Manual
 Training
 SOP
 Quality Assurance Cycle
 Quality by Design (QbD)
 Quality Risk Management (QRM)
 Functions of QA
 Observation & Findings
 Conclusion
 Reference
Quality Assurance

3. Methods of Data Collection
Quality Assurance
 Online searching
 Reference books
 Published Journal
 Regulatory guideline

4. What is Quality Assurance (QA) ?
Quality
Assurance
• The process of checking
to see whether a product
or service is satisfying
customer requirements
• Quality
• GMP
• Quality Control (QC)
Quality Assurance

5. Quality Assurance vs. Quality Control
Quality Assurance

6. Development of The Concept of
Quality Assurance
 Tylenol Incident:
 A total of seven people died in the original
poisonings in 1982. All the victims had taken
Tylenol-branded acetaminophen capsules that had
been laced with potassium cyanide. And several
more deaths in subsequent copycat crimes.
Quality Assurance

7. Factors Affecting Product Quality
Use of production technology
Skill set, tools, and experience of
labor
Availability of needed raw
materials
Storage facilities
Carriage or transport facility
Quality Assurance

8. Components of Quality Assurance
 The components of a QA are often grouped into three levels,
variously labeled :
Quality Assurance

9. Continued…
Document Review
Inspection of
local/imported,
manufacturing site,
market place
Product Testing
Reporting
Data
Analysis
And
Evaluation
Decision
making
Figure: QA Framework
Quality Assurance

10. Continued…
Setting up The System:
 Firstly making a quality plan after taking decision of
implementation of quality system
 Collection of sufficient funds
 Regularly update and change the system based on the
need of the organization
NB: For new plan, quality system is planned before the
startup of the plant and for existing plant, quality system is
developed based on the existing practice.
Quality Assurance

11. Continued…
Features of QA System
Practical and Realistic
Not impose extra workload to the worker
Avoid unnecessary time-consuming
tasks
Quality Assurance

12. Continued…
Quality Manual:
The Quality Manual is composed of the management documents
needed to implement the QA program. It should contain the
description of the pharmaceutical quality system. The description
should include:
 The quality policy
 The scope of the pharmaceutical quality system
 Identification of the pharmaceutical quality system processes, as
well as their sequences, linkages and interdependencies. Process
maps and flow charts can be useful tools to facilitate depicting
pharmaceutical quality system processes in a visual manner
 Management responsibilities within the pharmaceutical quality
system
Quality Assurance

13. Continued…
Training:
 Every staffs are trained for the enhancement of skill and
expertise.
 The upper management develop policy and stands,
assign responsibility and maintain accountability.
 The supervisor takes the responsibility of developing
training manual and conducting those training.
 The responsibility of the operating personnel is to take
part in those training and become expert.
Quality Assurance

14. Continued…
 Types of Training:
Training
Scheduled
Training
Non-Scheduled
Training
• Planned and scheduled
at specific time
• Conducted in case of
any anomalies,
deviation of critical
quality criteria or
quality failure
Quality Assurance

15. Continued…
Standard Operating Procedures:
 Documents detailing all specific operations and methods,
including sampling, transportation, analysis, use of and calibration
of equipment, production of reports and interpretation of data.
They are the internal reference manual for the particular procedure
and should detail every relevant step. Anybody of the appropriate
training level should be able to follow the SOP.
 An SOP should have a descriptive title and also have a unique
reference and version number.
 The purpose of the SOP should be stated alongside the variables
measured, the expected range of values, the limitations of the
method and the expected precision and accuracy.
Quality Assurance

16. Continued…
The Quality Assurance Manager :
For larger projects, proper management of QA will require the
appointment of a QA manager to-
 Liaise with staff
 Manage data archives
 Conduct regular audits and reviews
 Report on any QA issues
 Inspect facilities and procedures regularly
 Trace samples and documents back through the system
 Ensure that all appropriate records have been kept.
Quality Assurance

17. Quality Control Cycle:
Quality Assurance

18. Quality by Design (QbD):
The FDA publication defined Quality by Design as:
 Developing a product to meet predefined product quality, safety and
efficacy
 Designing a manufacturing process to meet predefined product quality,
safety and efficacy
Figure: Quality by Design
Process design and
Process development
Continued Process
verification
Process control
strategy definition
Process validation
Quality Assurance

19. Continued...
The main objectives of Quality by Design:
 To facilitate innovation and continuous improvement
throughout the product lifecycle
 To provide regulatory flexibility for specification
setting and post-approval changes
 To streamline the submission and review processes
Quality Assurance

20. Continued…
 Elements of QbD:
1
• Define Target Product Quality Profile
2
• Identify Critical Quality Attributes, Process
Parameters, and Sources of Variability
3
• Design Product and Manufacturing Processes
4
• Control Manufacturing Processes to Produce
Consistent Quality over Time
5
• Risk assessment & risk control
6
• Process Design and Development
Quality Assurance

21. Continued…
Figure: QbD Development Process
Quality Assurance

22. Continued…
 Traditional vs. QbD:
Aspects Traditional (Quality by
Testing)
QbD
Pharmaceutical
Development
Empirical, Random, Focus on
optimization
Systematic, Multivariate experiments,
Focus on control strategy and
robustness
Manufacturing
Process
Fixed Adjustable within design space,
managed by company’s quality
systems
Process Control Some in-process testing PAT utilized, Process operations
tracked and trended
Product Specification Primary means of quality
control, based on batch data
Part of the overall quality control
strategy, based on desired product
performance
Control Strategy By testing and inspection Risk-based control strategy, real-time
release possible
Quality Assurance

23. Quality Risk Management
Figure: Quality Risk management
Quality Assurance

24. Functions of QA
Quality Assurance
Quality
Assurance
Issue of
batch
production
records
Review of
batch
production
records
Preparation
and review
of SOPs
Review of
quality control
reports
Issue of
product
release
certificates
Upkeep of
reference
samples
Complaint
handling and
investigations
Validations

25. Observations & Findings
Reduces the chance of batch
failure
Only department that closely
related to every other department
Works help in hand with other
department to ensure quality
product and providing safety to
public health.
Quality Assurance

26. 


Recommendation
Quality Assurance
• Motivate the
workforce
• SOPs should be
overhauled regularly
and updated if
necessary
• Arrange rewards for
obeying rule properly
• Make penalty for
disobeying any
rules
• The system should
be made automated
and online software
based

27. Conclusion
“Quality is never an accident; it is always the result
of high intention, sincere effort, intelligent
direction and skillful execution; it represents the
wise choice of many alternatives.”
-William A. Fostar
Quality Assurance

28. Reference
 Lawrence, X. Y. Pharmaceutical quality by design: product
and process development, understanding, and control.
Pharmaceutical research, 2008; 25(4): 781-791.
 Banker, G. S., Siepmann, J., & Rhodes, C. (Eds.). Modern
pharmaceutics. 2002; CRC Press.
 Elassy, N. (2015). The concepts of quality, quality assurance
and quality enhancement. Quality assurance in education.
 https://fdocuments.net/document/chapter-19-quality-
assurance-for-pharmaceuticals-19-quality-assurance-for-
pharmaceuticals.html, 15/09/2020, 8.30pm.
Quality Assurance

29. Quality Assurance