Pharmaceutical quality management

1. PREPARED BY : BHA
VIK PATEL
GUIDED BY : MR. SHANTILAL
PADHIYAR
[ASSISTANT PROFESSOR ]
DEPARTMENT OF CHEMISTRY
FACULTY OF PHARMACY,
DHARMSINH DESAI UNIVERSITY

2. TABLE OF CONTENTS
 Introduction
• Historical Background
• Benefits Of QMS
 ELEMENTSAND REQUIREMENTS OF QMS
 ISO 9001:2015 AND OTHER QMS STANDARDS
⚫ Documentation : Principles of the ISO 9000 Standard
⚫ Documentation - Principles of the ISO 9000 Standard – Cont
⚫ ISO and Total Quality Management Working Together
 Total Quality Management [ TQM ]
⚫ Concept of TQM
⚫ Characteristics of TQM
⚫ Principles of TQM
⚫ The key elements of theTQM
⚫ Advantages of TQM
⚫ Disadvantages of TQM
 SIX SIGMA CONCEPT
⚫ PHARMACEUTICALQUALITY SYSTEM [Management Responsibilities ]

3. INTRODUCTION
⚫ What is QMS?
⚫ QMS is a structured collection of policies, processes,
documented procedures and records and their associated
responsibilities .
Policies
Processes
Procedures

4. Historical Background:
1920s to
1960s
1970s
1990s
2008
2017
EXCELLENT
QUALITY
PRODUCT OR
SERVICE

5.  What are the benefits of QMS?
Simplify
Clarify
Control
 Better quality of products and services.
 Lesser waste of resources (time and materials).
 Improved customer satisfaction.
 Improved profitability and improved bottom line.

6.  Defining, improving, and controlling processes.
 Reducing waste
 Preventing mistakes
 Lowering costs
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction
 Communicating a readiness to produce consistent results

7. ELEMENTS AND REQUIREMENTS
OF A QMS :
⚫ Each element of a quality management system helps achieve
the overall goals of meeting the customers’ and organization’s
requirements. Quality management systems should address an
organization’s unique needs; however, the elements all
systems have in common include:
⚫ The organization’s quality policy and quality objectives
⚫ Quality manual
⚫ Procedures, instructions, and records
⚫ Data management
⚫ Internal processes
⚫ Customer satisfaction from product quality
⚫ Improvement opportunities
⚫ Quality analysis

8. ISO 9001:2015 AND OTHER QMS
STANDARDS
 ISO 9001:2015 is the most recognized and implemented
quality management system standard in the world. ISO
9001:2015 specifies the requirements for a QMS that
organizations can use to develop their own programs.
 Other standards related to quality management systems
include the rest of the ISO 9000 series (including ISO 9000
and ISO 9004), the ISO 14000 series (environmental
management systems), ISO 13485 (quality management
systems for medical devices), ISO 19011 (auditing
management systems), and IATF 16949 (quality management
systems for automotive-related products).

9. Documentation :
Principles of the ISO 9000 Standard:
• Customer Focus – understand needs, meet
requirements, exceed expectations
• Leadership – unity of purpose, organizational direction,
empowerment, achieve objectives
• Involvement of People – fully involved employees, to
benefit the organization
• ProcessApproach – accomplishments by processes,
resources must be managed

10. Documentation - Principles of the ISO 9000
Standard – Cont :
🞄 SystemApproach to Management- processes are
managed as a system.
🞄Continual Improvement – permanently applied to the
organization, its people, their processes, their systems
and their products.
🞄 FactualApproach to Decision Making – decisions based
on analysis of accurate, relevant and reliable data.
🞄 Mutually Beneficial Supplier relationships –
organization and suppliers benefit from each other’s
resources and knowledge .

11. Documentation – Cont. :
operating the
 Organizational Chart :
• Illustrates managements responsibility for
quality system.
 Quality Procedures : may be referenced in this manual.
 Quality Objectives:
• Goals related to quality – must be in sync with the Quality
Policy.
• Assigned to organizational functions.
• Tracked by Top Management.

12.  Quality Procedures:
⚫Step by step what the company does to meet policy
⚫Aprocedure for each ISO principle
⚫Processes for procedures that affect quality
 Forms. Records etc:
• Proof of activities
• Documentation for auditors
• Ensure consistency of the firms operations
• Verify conformance to standards

13. ISO and Total Quality Management
Working Together :
⚫TQM requires everything required by ISO 9000
registration.
⚫No international certification for TQM but may seek ISO
9000 certification to meet customer demands.
⚫ISO 9001 registration can be a good first step to TQM.
⚫A organization that has documented processes and is
involved in total quality management should find it easy to
prepare for ISO 9000 certification.
⚫Likewise an organization registered under ISO 9001 will
have a head start in implementing total quality.

14. Total Quality Management [ TQM ]
⚫ Total - made up of the whole
⚫ Quality - degree of excellence a product or service provides
⚫ Management - act, art or manner of planning,
controlling, directing,….
Therefore, TQM is the art of managing the whole to achieve
excellence.

15. Concept of TQM
• Produce quality work the first time.
• Focus on the customer.
• Have a strategic approach to improvement.
• Improve continuously.
• Encourage mutual respect and teamwork.

16. Characteristics of TQM :
⚫ Committed management
⚫ Closer customer relations.
⚫ Closer provider relations.
⚫ Benchmarking.
⚫ Increased training.
⚫ Open organization
⚫ Employee empowerment.
⚫ Flexible production.
⚫ Process improvements.
⚫ Process measuring

17. Principles of TQM :
1. Produce quality work the first time and every time.
2. Focus on the customer.
3. Have a strategic approach to improvement.
4. Improve continuously.
5. Encourage mutual respect and teamwork

18. The key elements of the TQM :
 Focus on the customer.
 Employee involvement
 Continuous improvement

19. Focus on the customer :
• It is important to identify the organization’s
customers.
• External customers consume the
organization’s product or service.
• Internal customers are employees who receive
the output of other employees.

20. • Since the quality is considered job of
all employees, employees should be
involved in quality initiatives.
• Front line employees are likely to
have the closest contact with
external customers and thus can make
the most valuable contribution to
quality.
• Therefore, employees must have the
authority to innovate and improve
quality.
Employee Involvement:

21. Continuous improvement:

22. Continuous improvement:
• Continuous improvement means that small, incremental
improvement that occurs on a regular basis will eventually
add up to vast improvement in quality.
• TQM is the management process used to make continuous
improvements to all functions.
• TQM represents an ongoing, continuous commitment to
improvement.
• The foundation of total quality is a management philosophy
that supports meeting customer requirements through
continuous improvement.

23. Advantages of TQM
• Improves reputation- faults and problems are spotted and
sorted quicker.
• Higher employee morale- workers motivated by extra
responsibility ,team work and involvement indecisions of
TQM.
• Lower cost.
• Decrease waste as fewer defective products and no need for
separate.

24. Disadvantages of TQM
• Initial introduction cost.
• Benefits may not be seen for several years.
• Workers may be resistant to change.

25. SIX SIGMA CONCEPT
• Six Sigma is a set of techniques and tools for process improvement.
It was introduced by engineer Bill Smith while working at Motorola
in 1986.
• Jack Welch made it central to his business strategy at General
Electric in 1995.
• Six Sigma seeks to improve the quality of the output of a process by
identifying and removing the causes of defects and minimizing
variability in manufacturing and business processes.
• It uses a set of quality management methods, mainly empirical,
statistical methods, and creates a special infrastructure of people
within the organization, who are experts in these methods.

26. • This increase in performance and decrease in process variation.
• It leads to defect reduction and improvement in profits, employee
morale and quality of product.
• Sigma(σ) is a Symbol of Standard Deviation Standard Deviation(σ):
A dispersion of average variance from the required value in a set of
data.

27.  Improve customer satisfaction (Internal and External)
 Improve the quality of product and service
 Reduce the process cycle time
 Overall cost saving up to 30%
 Development of staff skill
 Where it is used:
 Manufacturing and service industries
 Sales and Marketing
 Accounting and Financing
OBJECTIVES OF 6σ

28.  Six Sigma projects follow two project methodologies inspired by
Deming's Plan-Do-Check-Act Cycle.
 These methodologies, composed of five phases each, bear the
acronyms DMAIC and DMADV.
 DMAIC is used for projects aimed at improving an existing
business process.
 DMADV is used for projects aimed at creating new product or
process designs.
METHODOLOGIES

29. PHARMACEUTICAL QUALITY SYSTEM :
⚫ Management Responsibilities:
Management Commitment
Quality Policy
Q uality Planning
Resource Management
Internal Communication
Management Review