QUALITY MANAGEMENT SYSTEM

CONTENTS:
 OBJECTIVE OF QMS:
 Quality Management System & Certifications:
 Concept of Quality
 Total Quality Management
 Quality by Design (QBD)
 Six Sigma Concepts
 Out of Specifications (OOS)
 Change Control
 Introduction to ISO 9000 series of quality systems
standards
 ISO 14000
 NABL
 GLP Fig.2 Objective of QMS

 QUALITY MANAGEMENT SYSTEMS : CONCEPT OF QUALITY:

 Totality of the features & characteristics of product or service.
Quality
Control  Ability to satisfy stated or implied need.

Quality Quality
Planning QMS Assurance

Quality
Improvement

Fig.1 (Quality Management System)

 Quality Control: maintain standard

 Quality Assurance: Maintain desired level of quality
 Quality Planning: To determine the important factors for project
& figuring out cost
 Quality Improvement: Documenting their contribution Fig.3 (Concept of Quality)
 TOTAL QUALITY MANAGEMENT:
 Customer – Oriented Process  BENEFITS OF TOTAL QUALITY MANAGEMENT:
 Continuous improvement of business operation  Strengthened competitive position
Principle of total quality management:  Higher productivity
 Produce quality work  Enhance market image
 Focus on customer  Elimination of defect & waste
 Employee involvement  Higher profitability
 Continuous improvement  Reduced cost & better cost management
 Time required to develop new innovation, and a reputation as a quality
 MODEL OF TOTAL QUALITY  Makes the company adopt more readily to changes
MANAGEMENT:  Makes the company more sensitive to customer needs
 Improve access to global markets, higher customer retention level
 Performance which will meet or exceed customer expectation
Customer
Focus
 Element of Total Quality Management:

Total TQM Planning

Participatation Process
Model

Process
Management

Fig.4 TQM Model

Fig.5 Element of TQM
 QUALITY BY DESIGN:  PROCESS OF QUALITY BY DESIGN :
Systematic approach to development- Labeled use, safety Knowledge space
& efficacy
 Begins with predefine objective
 Emphasizes products
Design formulation Established
 Process understanding Define quality target control
 Process control product
 Based on sound sciences &quality risk management
Identify critical Monitor &
 KEY ASPECTS OF QUALITY BY DESIGN: material attributes & update
critical process
Target Product Profile
 ADVANTAGES:
Identification of quality attributes  Benefits to industry
 Better understanding of the process
 Less batch failure
 Better development decision
Risk assessment to identify process/product  Less intense regulatory over sight & less post approval submission
risk  More efficient technology transfer to manufacturing
 Build scientific knowledge base for all products
 Empowerment of technical staff
Design Space Development  Risk based approach & identification
 Avoid regulatory compliance problem
 Greater regulatoryconfidence of robust products
Control Strategy  Efficient,agile , flexible system
 Better innovation due to the ability to improve processes without
resubmission to the FDA when remaining in the design space

Life Cycle Management

 SIX SIGMA CONCEPT :  FOCUS OF SIX SIGMA:
 Business statistical strategy
 Identifying defect &removing manufacturing defects
 Improve quality

 SIX SIGMA OBJECTIVES:

 Overall business improvement: Fig.6 Aim of Six Sigma
Six sigma methodology focuses on business improvement.
Beyond reducing the number of defect present in any given  ELEMENTS OF SIX SIGMA:
numberof products.
 Remedy defect /variability:
Any business seeking improved number must reduced the
number of defective product or services products.
 Reduced costs:
Reduced cost equal increase profits.
 Improve cycle time:
Any reduction in the amount of time it takes to produce a
product or perform a service means money saved, both in
maintenance costs& personnel wages.
Fig.7 Element of Six Sigma
 OUT OF SPECIFICATION :  CHANGE CONTROL:
 The result obtained out of define test limit is called Change control is a quality tool & management to maintain
Out Of Specification.(OOS) & keep the record of all changes as a history, changes can be
 Drug is not meeting documented standard. related facility, documentation, system, equipment,
instrument, procedure, layouts & products etc.
 CHANGE MANAGEMENT PROCESS:

 OOS FOUND DUE TO :

OOS

Fig.8 Change Management Process

 IMPORTANCE OF CHANGE CONTROL:

Fig.9 Importance of change control

 INTRODUCTION TO ISO 9000 SERIES OF

QUALITY SYSTEM STANDARD:
Fig.10 QMS Principle
ISO 9000 is series of standard development and published by the ISO
that defines establish and maintain an effective quality assurance  ADVANTAGES OF ISO 9000:
system for manufacturing and service industries.  Increase marketability.
 Reduced operational expenses.
 International organization for standardization.
 Better management control.
 Series of quality management system standard.
 Increase customer satisfaction.
 Provide guidance & tools for companies & organisation.
 Improve internal communication.
 To ensure that their product & services consistently meet
 Improve customer service.
costomer’s requirement.
 Attractiveness to investor.
 For consistant improvement in quality.
 ISO 14000:  ISO 14000 POLICY:
 Provides practical tools to manage the environmental  Prevention of pollution.
responsibilities of companies & organisation.  Continual environmental improvement.
 Standard is related to Envirnmental Management System.(EMS)  Applicable in size & scope.
 Available to the public.
 FEATURES:  Commitment to comply with environmental laws & regulation.
1. Minimum harmful effect on environment.
2. Continuous improvement to achieve the desired performance.

ISO 14000 is divided in two parts:  PRINCIPLE OF ISO-14000 PDCA MODEL:

1. Organizational evaluation standards.
2. Product evaluation standards

Fig. 12 Principle of ISO 14000 PDCA Model

 ISO 14000 CERTIFICATION PROCESS:

 Preliminary assessment.
 Document review.
 Initial assessment.
 Main assessment.
 Certification/registration.
Fig.11 Environmental management ISO 14000  Surveillance.
 BENEFITS OF ISO 14000:  NABL & ISO PRINCIPLE:
 Better conformance to environmental regulations  Accreditation Systems: ISO/IEC 17011 (2017) (Conformity
 Greater marketability assessment-requirements for accreditation bodies accrediting
 Better use of resources conformity assessment bodies).
 Higher quality goods and services  Testing and Calibration Laboratories: ISO/IEC 17025 (2005)
 Increased levels of safety and ISO/IEC 17025 (2017) (General requirements for the
 Improved image and increased profits competence of testing and calibration laboratories).
 Medical Laboratories: ISO 15189 (2012) (Medical laboratories-
requirements for quality and competence).
 National Accreditation Board for Testing and
 RMP (Reference Material Producers): ISO 17034 (2016)
Calibration Laboratories (NABL): (General requirements for the competence of reference
 NABL is autonomous constitute. material producers.
 It is providing accreditation to the government, industry etc.

SCOPE OF NABL ACCREDITATION

 NABL VISION: BENIFITS OF ACCREDITATION:
To be the world leading accreditation body and to enhance
 Increased confidence in testing /calibration reports issue by.
stakeholders confidence in its services
.laboratory
 NABL MISSION:  Better control of laboratory operation
 Saving in terms of time and money due to reduction of elimination
To strengthen the accreditation system accepted across the globe .of the need for retesting of product
by providing high quality, value driven service, fostering
 Customers can search and identify the laboratories accredited by .
APLAC/ILAC MRA, empanelling competent assessors, creating
NABL for their specific requirement
awareness among the stake holders, initiating new programs
 Potential increase in business due to enhance customer confidence
supporting accreditation activities and pursuing organizational
excellence.

 ADVANTAGES OF NABL: COMPLAINTS:

 NABL is open to receiving complaints for any of the activity ...
performed by its official assessors, accreditation committee.member and
the accredited CABs.
 The details provided in NABL 132 “procedure for dealing with
..complaints”
 NABL is open to appeals from the CABs against its decision
 The details are provided in NABL 134 “procedure for dealing with
.appeals against adverse decision taken by NABL”

NABL CAN PROVIDE ACCRIDITATION:

 Private or government laboratory
 Small operation to large multi filed laboratory
 Site facility, temporary filed and mobile laboratory
Fig. 13 Advantages of NABL
GLP- GOOD LABORATORY PRACTICE:
WHY WAS GLP CREATED?
Good laboratory practice is the FDA regulation
 In the early 70sFDA became aware of cases o poor
OBJECTIVE: laboratory practice all over the united state
 Data generation without conduct of study
 Make sure data is traceable  Falsification of the laboratory work
 Promote international acceptance of test  Replacement of dead animal and the fabrication of the test
 Adopt good and safe operating procedure and recording result
system  They discovered a lot of fraudulent activities and a lot of
 Prevent the human error in the performance of the job poor lab practice
 Prevent equipment error in the measurement  Example of some of these poor lab practices found where
 Improve efficient performance of the job  Equipment not been calibrated to the standard form,
 Prevent unsafe and hazardous acts which could affects therefore giving wrong measurement
individual and /or properly  Inadequate test system
 Incorrect or in accurate account of actual lab study
PURPOSE OF GLP:

 GLP is to certify that every step of the analysis is STANDARD OPERATING PROCEDURE:
valid or not  Routine inspection, cleaning, maintenance, testing and
 To promote the development of quality test data
calibration
 Avoid repetition of study  Action to be taken in response to equipments failure
 Obtained reliable and reproducible data  Keeping record, reporting, storage, mixing and retrieval of
 Shorten the registration time of the drug data
 Obtained comparable data between countries  Definition of raw data
 GLPs have heavy emphasis on data recording,  Analytical method
Record and specimen retention
 Assure the quality and integrity of data submitted
to FDA in support of the safety of regulatory product
HOW TO PRACTICE THE GLP? BASIC ELEMENTS IN GLP:

 General provision facilities

 equipment
 Testing facilities operation
 Test and control articles
 Record and reports
 Protocol for and conduct of study
 Organization and personnel

SOP
Storage &
Reporting of retension of
study record &
Material

Performance of GLP Test Facility

the study Organisation &
Principle personnel

Quality
Test System assurance
programme
Facilities

Fig.14 GLP principle

Fig. 15 Basic elements in GLP
GOALS OF GLP: REFERENCES:
 To make life difficult for study personnel 1. B.P Mahesh, Dr M.S Prabhuswami Six Sigma Concept,
 To ensure accountability International Journal& Advance Research Management
 To ensure ability to reconstruct the study Volume-1, Issues- 2010 page no : 20-22.
2. Dr.K.P Sampat Kumar Dr. Debjit Bhowmik Shambaditya
ADVANTAGES OF GLP: Goswami Industrial Pharmacy 2, First Edition 2020 Nirali
Prakashan Page no 4.8-4.28.
Priclinical safety & residue
Increse the public confidence
safety 3. Dr.Swarnali Das Poul, Mrs Gunjan Jeswani Quality by
Design, Pharmaceutical Quality Assurance PV
Advantages of Publication, Page no 60-63.
GLP
4. https://www.economicsdiscussion.net/quality-
Shortens the time-to-market management/total-quality-management-principles/31865.
Mutual acceptance of data
for new product
5. https://www.pmeasuring.com/blog/advisory-services-
quality-by-design/
Fig.16 Advantages of GLP

DISADVANTAGES OF GLP: Department: PHARMACEUTICS

More man Subject: INDUSTRIAL PHARMACY - II

power is
required
Time Expensive Guide By: Ms. ADSARE VAISHALI
consuming process
process
Prepared By: Mr. GUNJAL GANESH

Disadvantages Ms. JADHAV ASHWINI

of GLP
Ms. JADHAV SHWETA

Class: FINAL YEAR B.PHARMACY

Fig.17 Disadvantages of GLP
Academic Year: 2021-2022