Quality management systems are important for companies to meet customer needs and expectations. Key aspects of quality management include quality assurance to ensure products meet performance and reliability standards, and quality control which implements quality policies and procedures. Major international quality standards include ISO 9001, while FDA regulations like 21 CFR parts 210, 211, and 212 provide guidelines for pharmaceutical Good Manufacturing Practices. An effective quality management system focuses on parameters like performance, efficiency, effectiveness and user satisfaction to deliver high quality products.

1. Quality
Management
Systems
Presented by: Tejas Dhanuka
Guide:Dr. Sudir Pandya.
Dr. D.Y. Patil College
of Pharmacy, Akurdi.

2. Topic
Define quality and enumerate the points which
you think are more important for quality
parameters.

3. Quality parameters
Performance, efficiency,
effectiveness and user
satisfaction.
Definitions
Maintainability
expectations of that
customer
Evolution of Quality
A key element for
success in the present
competitive market
Dimensions of Quality
Performance, features,
reliability, conformance,
Points
Back to Agenda

4. Introduction
It is widely identified that
customer only buys the products
with good quality, desired
functions, and affordable price.
So that manufacturers construct
some management systems to
design and produce the products to
get customer needs and
expectations showcasing good
quality and lower costs

5. Quality assurance
The systematic efforts taken to
ensure 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.
A quality assurance strategy
referred to as the DMAIC model
(define, measure, analyze, improve,
control).

6. The aspect of management that
determines and implements the
“quality policy”
Quality
Management
System
Source: shorturl.at/gCJM6

7. Quality parameters
ISO pharmaceutical industry
certifications include: ISO 9001
ISO 9001 is the most widely used
quality management standard
internationally
It provides a framework and set of
principles for organizational
management
Certification to this standard helps
your business achieve customer and
stakeholder satisfaction

8. Competitive Analysis
Determine who your
competitors are.
Determine what products your
competitors offer.
Perform a SWOT Analysis to
learn their strengths,
weaknesses, opportunities, and
threats.

9. Competitive Analysis
Develop new products and
services
Uncover market trends
Market and sell more
effectively
Identify gaps in the market

10. Code of Federal Regulations
The codification of the general
and permanent rules and
regulations
The Office of the Federal
Register, also known as the
agency of the National Archives
and Records Administration
(NARA) publishes the CFR.

11. CFR Importance
Get updates on literally every
subject that the federal
government has jurisdiction to
manage.
CFRs are updated on a routine
basis based upon new federal
legislation, changes in
economic or social objectives.

12. 4 Major Quality
Requirements
21 CFR Part 314
regulation
01
21 CFR Part 210
regulation
02
21 CFR Part 211
regulation
03
Back to Agenda
21 CFR Part 212
regulation
04

13. 21 CFR Part 314
regulation
Outlines the procedures and
requirements for submitting an FDA
application for a new product
The exact process by which the FDA
appropriately reviews and approves
new applications.

14. 21 CFR Part 210
regulation
cGMP methods, facilities, and
controls for the manufacture,
processing, packing, and holding of
a pharmaceutical product.
Ensures that the product meets
major safety and manufacturing
requirements enforced by the FDA
and other regulatory bodies.

15. 21 CFR Part 212
regulation
Personnel and resources
Quality assurance
Facilities and equipment
Control of components, containers
Production and process controls
Laboratory controls
Finished drug product controls
Packaging and labeling
Distribution, Records
Complaint handling

16. Good manufacturing
practice (GMP)
A system for ensuring that products are
consistently produced and controlled
according to quality standards.
It is designed to minimize the risks
involved in any pharmaceutical
production that cannot be eliminated
through testing the final product.

17. QMS tools
Process performance and product
quality monitoring system.
Corrective action and preventive
action (CAPA) system.
Change management system.
Management review of process
performance and product quality.

18. ASTM
American Society for Testing and
Materials
The first Bioprocessing Equipment
(BPE) Standard.
Standard has brought together,
scrutinized, and refined industry
accepted methodologies
A comprehensive set of standards
that are integral to the
pharmaceutical industry

19. Good practices
Drug discovery: Good Laboratory
Practice
Drug trials: Good Clinical Practice;
Manufacturer: Good Manufacturing
Practice
Distribution: Good Distribution
Practice
Storage: Good Storage Practice.

20. Regulatory
requirements
EU regulations require all
pharmaceutical manufacturers to
comply with EU Good Manufacturing
Practices (GMPs) if they want to supply
products to the EU.
In the US, the regulatory standard for
human pharmaceutical products is the
Current Good Manufacturing Practice
regulations, which are enforced by the
FDA.

21. Sanitation and
hygiene
The process, covering personnel,
premises, equipment, materials,
containers, and cleaning and
disinfection products.
A manufacturer has responsibility
to ensure the pharmaceutical
products are fit for use, and have
adequate safety, quality and
efficacy.

22. Dimensions of
Quality
In 1987, David A. Garvin explained 8
critical dimensions of quality that can
work as a framework for strategic
analysis are Performance, features,
reliability, conformance, durability,
serviceability, aesthetics, and
perceived quality as follows.

23. Features:
ISO
pharmaceutical
industry
certifications
include: ISO 9001
01
Will they be they
tangible or non-
tangible benefits?
02
Write a specific
company problem
here
03

24. Evolution of Quality
The important issues that business has
focused on in the last two decades is
quality.
The other issues are cost and delivery.
Quality is a key element for success in
business in the present competitive
market.

25. History of Quality
QUALITY
01
FOUNDATIONS
02
CONCLUSION
03

26. QUALITY
Provides better design predictions
Recognition that industrial scale-
up and commercial manufacturing
experience provides knowledge
about the process and the raw
materials used.
Distribution: Good Distribution
Practice
Understand the work that he and his
people are responsible for

27. FOUNDATIONS
Provides better design predictions
Know your employees.
Be trustworthy.
Create a culture that fosters
individual growth.
Allow employees to rise to
challenges without fear and
competition.

28. CONCLUSION
Today’s leader can create an
organization that is more capable
and driven than any seen before.
Production capabilities and quality
improvements will be the
inevitable side effects

29. References
PV A Textbook Of Pharmaceutical
Quality Assurance By Sanjay and
Mayur and Rageeb and Krishna
Pharmaceutical Quality Assurance
Paperback – 1 January 2007
by Manohar . A. Potdar