The document discusses International Organization for Standardization (ISO) and ISO quality standards. It provides background on ISO, describing it as being located in Switzerland and established in 1947 to develop common international standards. It then summarizes key points about ISO 9001 and ISO 14001, which help organizations implement quality and environmental management, respectively. The document outlines objectives and benefits of ISO 9000 standards, such as achieving quality improvement and providing management confidence. It also lists 10 steps for ISO registration and some potential problems with certification.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Total Quality Management in Pharma IndustryInthiyazBegum
INTRODUCTION:
Total quality management increases the customer satisfaction by boosting the quality.
In an increasing competitive market firms with a continuous improvement culture and external focus are more likely to survive and prosper.
What is TQM?
TQM is an approach to improving the effectiveness and flexibilities of business as a whole.
It is essentially a way of organizing and involving the whole organization every department, every activity and every single person at every level.
SIGNIFICANCE OF TQM:
The importance of TQM lies in the fact that in encourages innovation, make the organization adaptable to change , motivate people for better quality ,and integrates the business arising out of the common purpose and all those provide the organization with a valuable and distinctive competitive edge.
Elements of TQM :
Be customer focused
Do it right the first time
Constantly improve
Quality is an attitude
Reasons for TQM failure
TQM fails because :
Top management sees no reasons for change
Top management is not concerned for its staff
Top management is not committed to the TQM programmer
The company loses interest in the programmer after six months
The work force and the management do not agree on what needs to happen.
Benefits of TQM:
Improvement of quality
Employee participation
Team work
Working relationship
Customer satisfaction
Employee satisfaction
IMPORTANCE OF TQM IN PHARMA INDUSTRY :
Handling:
Containers should be opened carefully and subsequently resealed in an approved manner.
Highly sensitive materials such as penicillin's and cephalosporin's should be handle in separate production area.
Highly active should be manufacture in a dedicate area and using delectated reagent.
Storage:
Secure storage facilities should be designated for use to prevent damage of materials.
Should be kept clean and tidy and subject to the appropriate pest control measurement.
Environmental conditions should be recorded.
Storage conditions for API should be based upon stability studies taking into account time.
Packaging:
Labelling and packaging processes should be defined and controlled to ensure that correct packaging materials are used correctly and other specified requirements are met.
Printed labels should be securely to avoid mix ups arising store.
Facilities and equipment :
The location ,design, and construction of buildings should be suitable for the type and stage of manufacture involved protecting the product from contamination and protecting operators and the environment from the product.
Equipment surfaces in contact with materials used in API manufacturing should be non reactive.
Conclusion :
Total quality management encourages participation amongst ,employees ,managers ,and organizations whole.
The responsibilities either its professional, social , legal, one that the rest with the pharmaceutical manufacturing for the assurance of quality.
Control should be practiced rigorously.
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Total Quality Management in Pharma IndustryInthiyazBegum
INTRODUCTION:
Total quality management increases the customer satisfaction by boosting the quality.
In an increasing competitive market firms with a continuous improvement culture and external focus are more likely to survive and prosper.
What is TQM?
TQM is an approach to improving the effectiveness and flexibilities of business as a whole.
It is essentially a way of organizing and involving the whole organization every department, every activity and every single person at every level.
SIGNIFICANCE OF TQM:
The importance of TQM lies in the fact that in encourages innovation, make the organization adaptable to change , motivate people for better quality ,and integrates the business arising out of the common purpose and all those provide the organization with a valuable and distinctive competitive edge.
Elements of TQM :
Be customer focused
Do it right the first time
Constantly improve
Quality is an attitude
Reasons for TQM failure
TQM fails because :
Top management sees no reasons for change
Top management is not concerned for its staff
Top management is not committed to the TQM programmer
The company loses interest in the programmer after six months
The work force and the management do not agree on what needs to happen.
Benefits of TQM:
Improvement of quality
Employee participation
Team work
Working relationship
Customer satisfaction
Employee satisfaction
IMPORTANCE OF TQM IN PHARMA INDUSTRY :
Handling:
Containers should be opened carefully and subsequently resealed in an approved manner.
Highly sensitive materials such as penicillin's and cephalosporin's should be handle in separate production area.
Highly active should be manufacture in a dedicate area and using delectated reagent.
Storage:
Secure storage facilities should be designated for use to prevent damage of materials.
Should be kept clean and tidy and subject to the appropriate pest control measurement.
Environmental conditions should be recorded.
Storage conditions for API should be based upon stability studies taking into account time.
Packaging:
Labelling and packaging processes should be defined and controlled to ensure that correct packaging materials are used correctly and other specified requirements are met.
Printed labels should be securely to avoid mix ups arising store.
Facilities and equipment :
The location ,design, and construction of buildings should be suitable for the type and stage of manufacture involved protecting the product from contamination and protecting operators and the environment from the product.
Equipment surfaces in contact with materials used in API manufacturing should be non reactive.
Conclusion :
Total quality management encourages participation amongst ,employees ,managers ,and organizations whole.
The responsibilities either its professional, social , legal, one that the rest with the pharmaceutical manufacturing for the assurance of quality.
Control should be practiced rigorously.
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
ISO 9001: 2008 Quality Management System (QMS) is a Process Standard & not Product Standard
ISO QMS International Standard ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade
This PPT is for creating basic awareness on Standard for Implementation, understanding the importance & Benefits of Standard to improve Business & journey towards Excellence
The detailed synopsis of QMS. It will definitely surpass, your desire to streamline, implement and brainstorm Quality Management in your organization. Perhaps, the 8 core principles of QMS is applicable for everyone and everywhere .
6. ISO stands for
I nternational
O rganization for
S tandardization
6
7. It is located in Switzerland and established in
1947 to develop common international
standards.
ISO derived from Greek word ISOS means
equal , homogeneous or uniform.
Main idea behind the development of ISO –
9000 is to maintain uniformity in the existing
quality standards
8. ISO 9001 and ISO 14001 in
brief
ISO 9001 and ISO 14001 are among ISO's most well
known standards ever.
They are implemented by more than a million
organizations in some 175 countries.
ISO 9001 helps organizations to implement quality
management.
ISO 14001 helps organizations to implement
environmental management.
9. Quality management
ISO 9001 is for quality management.
Quality refers to all those features of a product (or
service) which are required by the customer.
Quality management means what the organization does
to
ensure that its products or services satisfy the customer's
quality requirements and
comply with any regulations applicable to those products
or services.
achieve continual improvement of its performance
10. Environmental management
ISO 14001 is for environmental
management. This means what the
organization does to:
minimize harmful effects on the
environment caused by its activities,
to conform to applicable regulatory
requirements, and to
achieve continual improvement of its
environmental performance.
11. Objectives of ISO 9000 Standards
Achieve, maintain, and improve product
quality
Improve quality of operations to
continually meet customers’ and
stakeholders’ needs
Provide confidence to management,
employees, customers, and stakeholders
that quality requirements are fulfilled
11
12. Why adopt ISO 9000?
To comply with customers who require
ISO 9000
To sell in the European Union market
To compete in domestic markets
To improve the quality system
To minimize repetitive auditing by similar
and different customers
IS 9000
13. Benefits of ISO 9001
Enable to foreign exchange
It enable the company to build customer confidence
Concession for import
To enhance quality image of the company & gives a
competitive edge over other company.
Helps in minimising the total cost of an organisation.
Helps in motivating an organisation.
Increase efficiency and effectiveness.
14. Ten Steps to ISO Registration
ISO 9000
2. Select the appropriate standard
1. Set the registration objective
3. Develop and implement the quality system
4. Select a third-party registrar and apply
5. Perform self-analysis audit
6. Submit quality manual for approval
7. Pre-assessment by registrar
8. Take corrective actions
9. Final assessment by registrar
10. Registration!
15. Problems with Certification
Costs - application & maintenance
Time - application & maintenance
Level of internal expertise
Executive commitment
Selection of registration
15
