Quality management and GLP
STRUCTURE OF THE COURSE
LEARNING OUTCOMES
1. The student has gained insight in the different parts of the quality management systems and understands the link
between each of these.
2. The student knows the basic principles of good manufacturing practices & can apply these on practical cases
3. Understand & explain different requirements for a quality management system specific for production sites of
medical devices and suppliers and is able to create a pathway for a medical device to enter the commercial market.
4. The student understands the different aspects, rules, responsibilities, and interactions which exist in the clinical
research field and is able to apply these aspects on different practical cases.
5. The student is able to explain the need of good laboratory practices (GLP) and how they are implemented in non-
clinical research laboratories.
6. The student is able to explain the organization and follow-up of GLP at national and international level.
7. The student is able to explain what GLP compliance is and how this is evaluated.
PLANNING
EXAMINATION
- Practical assignments 25% final mark 10/20 required
o The students show that they can analyse a clinical study protocol, can report discovered issues and can
suggest potential action plans
o The students show that they can classify medical devices and can draw up a plan to take a medical
device to the market.
- Written exam 75% final mark
o The students show they understand the different parts of the quality management systems and
understand the link between each of these.
o The student show they know the different requirements for a quality management system specific for
production sites of medical devices and supplier.
o The student show they understands the different aspects, rules, responsibilities, and interactions which
exist in the clinical research field.
o The student show they know the need of good laboratory practices (GLP) and how they are implemented
in non-clinical research laboratories.
o The student show they understand organization & follow-up of GLP at national and international level.
o The student show they know what GLP compliance is and how this is evaluated.
,INTRO TO QUALITY MANAGEMENT SYSTEM (QMS) 27/09
- Pharma products: can change the physiology in your body & treat, prevent.. disease
- Medical device: these have mechanical functions
1. THE CONCEPTS OF QUALITY, QUALITY MAANGEMENT AND QMS
WHAT IS QUALITY?
The term “Quality” in industry?
- “Fitness for purpose” - “Meeting specifications”
- “Conformity to requirements” - “The right product at the right time at the right price”
- “Making goods which do not come back for customers who do”
Quality of what? Product, service, business performance, environmental impact…
THE COST OF (BAD) QUALITY
- Monetary costs: replacements, compensation, repairs, destruction/loss
- Process costs: investigating, retesting, remaking
- Loss of time: down time, disagreements with (internal/external) customers
- Image: complaints, recall, claims, law suits, bad media coverage
- And of course you might lose unhappy customers to competitors
o but satisfy an unhappy customer by helping them appropriately
o and they are more likely to return! (= service recovery paradox)
1. Quality applies to both products and services
2. Quality should be measurable
3. Quality has to be tailored to the customer’s needs
QUALITY MANAGEMENT EVOLUTION
Before industrial revolution: let’s say there is a shoe maker. He is doing this from start to end by
himself, manually. The products were made and adapted until they satisfied certain criteria of the
customers.
After the industrial revolution there was a rise of mass production. The shoe maker hires multiple
employees who create the shoes by mass. Each employee contributes only to a small part of the end
product, and it is no longer one person responsible (for quality) from start to end. The shoe maker
now cannot wait on orders of customers to make the shoes. He needs to think of it beforehand.
Now the shoe maker needs to develop quality management activities to check the quality of his
products. How do you provide confidence that quality requirements will be fulfilled?
,QUALITY MANAGEMENT SYSTEM (QMS)
A system gives rules, regulation and consistency to what we do to create order in chaos. A
management system is “A system to establish policy and objectives and to achieve those objectives”.
A QMS is “A management system to direct and control an organisation with regard to quality”. A
management system tries to establish quality policy -> it will think about the quality standard we
want to have in the company and of the product.
QUALITY MANAGEMENT ACTIVITIES:
- Product testing Activities needed for:
- Training of personnel - Quality Control
- Procedures and documentation - Quality Assurance
- Investigation of defects - Quality Improvement
- Preventive maintenance of equipment - Quality Planning
- …
QUALITY MANAGEMENT PRINCIPLES:
- Customer focus: internal customers & external customers
o “External customers are those who see your company mainly as a provider of something they buy.
Internal customers participate in your business by actually being a part of it”
- Leadership - People - Suppliers
- Process approach - Factual approach - Systematic approach
- Continual improvement: no differences between departments/people
WHAT IS THE POINT OF USING A QMS?
“The point of using a Quality Management System (QMS) is to clearly understand customer
requirements, then manage internal processes (leadership, design, production, …) so that they fulfil
these requirements in an effective and efficient way. A QMS also charges organizations with continual
improvement of these processes.”
**Effective vs. efficient: Efficiency = ability to accomplish something with the least wasted time, money, effort or competency
in performance. Effectiveness is defined as the degree to which something is successful in producing a desired result; success
QMS GONE WRONG: EXAMPLE OF THE HUBBLE TELESCOPE
No better quality pictures: the lens was not cut to the requirements of NASA. Several things went
wrong: the supplier cut it wrong but nobody tested it,… took a lot of money and time.
2. QMS STANDARDS
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
ISO = an international organization that determines standards. It is a collaboration between 163
countries and was established in 1926 as ‘International Federation of the National Standardizing
Associations (ISA)’. They develop standards for several industries. Some are QMS but also food
safety, environmental management systems…
, - ISO 9001:2015
o International standard for quality management systems (QMS)
o Can be applied to any organisation, regardless of industry/sector
o Using ISO9001, an assessment can be made whether an organisation is able to satisfy
demanded (customer) requirements.
- ISO 13485:2016
o Requirements for QMS for design and production of medical devices
o Harmonised with ISO 9001
GMP – EU AND FDA
This is based on regulations applied to manufacturers of pharma products. They have to follow the
GMP. There are differences between EU and America (FDA). Both have developed a GMP guidance.
Both have regulations with QMS requirements included regarding to GMP of pharma products.
However, some things are missing. Quality control (QC) is testing, whereas Quality
assurance (QA) is more high-level on the production level. Quality management is
then more on an organization level. GMP is between QC and QA as it talks about
quality control testing and production, but the part between GMP and QMS misses
from those GMP guidances:
- Other departments (only production and QC is included)
- Internal communication - Customer satisfaction
- Efficiency - Role of leadership, policy and objectives
- Business performance monitoring - Continual improvement
The GMP therefore are not sufficient to achieve a QMS. You need additionally some other standards
to implement: both the EU and FDA refer to ICH Q10 for those aspects of the QMS.
ICH: INTERNATIONAL CONFERENCE ON HARMONISATION
= Former ‘International Conference on Harmonisation’. It is focused on delivery of harmonised
guidelines for global pharmaceutical development.
- In 1960, 1970: large increase in laws and regulations about reporting and evaluating data on
quality, safety and efficacy of new pharmaceuticals
- Large variation in requirements between countries
➔ Urgency for rationalisation & harmonisation increased
- The European Commission pioneered (EU, Japan & US)
- 1990: government and industry representatives from EU, Japan and US established ICH
- Safety, Quality & Efficacy
o Quality guidelines: how you manufacture products
o Safety guidelines: preclinical aspects, GLP
o Efficacy guidelines: focused on clinical aspects, GCP
o Multidisciplinary guidelines: between Q, S and E
- ICH Q10: pharmaceutical quality system
STRUCTURE OF THE COURSE
LEARNING OUTCOMES
1. The student has gained insight in the different parts of the quality management systems and understands the link
between each of these.
2. The student knows the basic principles of good manufacturing practices & can apply these on practical cases
3. Understand & explain different requirements for a quality management system specific for production sites of
medical devices and suppliers and is able to create a pathway for a medical device to enter the commercial market.
4. The student understands the different aspects, rules, responsibilities, and interactions which exist in the clinical
research field and is able to apply these aspects on different practical cases.
5. The student is able to explain the need of good laboratory practices (GLP) and how they are implemented in non-
clinical research laboratories.
6. The student is able to explain the organization and follow-up of GLP at national and international level.
7. The student is able to explain what GLP compliance is and how this is evaluated.
PLANNING
EXAMINATION
- Practical assignments 25% final mark 10/20 required
o The students show that they can analyse a clinical study protocol, can report discovered issues and can
suggest potential action plans
o The students show that they can classify medical devices and can draw up a plan to take a medical
device to the market.
- Written exam 75% final mark
o The students show they understand the different parts of the quality management systems and
understand the link between each of these.
o The student show they know the different requirements for a quality management system specific for
production sites of medical devices and supplier.
o The student show they understands the different aspects, rules, responsibilities, and interactions which
exist in the clinical research field.
o The student show they know the need of good laboratory practices (GLP) and how they are implemented
in non-clinical research laboratories.
o The student show they understand organization & follow-up of GLP at national and international level.
o The student show they know what GLP compliance is and how this is evaluated.
,INTRO TO QUALITY MANAGEMENT SYSTEM (QMS) 27/09
- Pharma products: can change the physiology in your body & treat, prevent.. disease
- Medical device: these have mechanical functions
1. THE CONCEPTS OF QUALITY, QUALITY MAANGEMENT AND QMS
WHAT IS QUALITY?
The term “Quality” in industry?
- “Fitness for purpose” - “Meeting specifications”
- “Conformity to requirements” - “The right product at the right time at the right price”
- “Making goods which do not come back for customers who do”
Quality of what? Product, service, business performance, environmental impact…
THE COST OF (BAD) QUALITY
- Monetary costs: replacements, compensation, repairs, destruction/loss
- Process costs: investigating, retesting, remaking
- Loss of time: down time, disagreements with (internal/external) customers
- Image: complaints, recall, claims, law suits, bad media coverage
- And of course you might lose unhappy customers to competitors
o but satisfy an unhappy customer by helping them appropriately
o and they are more likely to return! (= service recovery paradox)
1. Quality applies to both products and services
2. Quality should be measurable
3. Quality has to be tailored to the customer’s needs
QUALITY MANAGEMENT EVOLUTION
Before industrial revolution: let’s say there is a shoe maker. He is doing this from start to end by
himself, manually. The products were made and adapted until they satisfied certain criteria of the
customers.
After the industrial revolution there was a rise of mass production. The shoe maker hires multiple
employees who create the shoes by mass. Each employee contributes only to a small part of the end
product, and it is no longer one person responsible (for quality) from start to end. The shoe maker
now cannot wait on orders of customers to make the shoes. He needs to think of it beforehand.
Now the shoe maker needs to develop quality management activities to check the quality of his
products. How do you provide confidence that quality requirements will be fulfilled?
,QUALITY MANAGEMENT SYSTEM (QMS)
A system gives rules, regulation and consistency to what we do to create order in chaos. A
management system is “A system to establish policy and objectives and to achieve those objectives”.
A QMS is “A management system to direct and control an organisation with regard to quality”. A
management system tries to establish quality policy -> it will think about the quality standard we
want to have in the company and of the product.
QUALITY MANAGEMENT ACTIVITIES:
- Product testing Activities needed for:
- Training of personnel - Quality Control
- Procedures and documentation - Quality Assurance
- Investigation of defects - Quality Improvement
- Preventive maintenance of equipment - Quality Planning
- …
QUALITY MANAGEMENT PRINCIPLES:
- Customer focus: internal customers & external customers
o “External customers are those who see your company mainly as a provider of something they buy.
Internal customers participate in your business by actually being a part of it”
- Leadership - People - Suppliers
- Process approach - Factual approach - Systematic approach
- Continual improvement: no differences between departments/people
WHAT IS THE POINT OF USING A QMS?
“The point of using a Quality Management System (QMS) is to clearly understand customer
requirements, then manage internal processes (leadership, design, production, …) so that they fulfil
these requirements in an effective and efficient way. A QMS also charges organizations with continual
improvement of these processes.”
**Effective vs. efficient: Efficiency = ability to accomplish something with the least wasted time, money, effort or competency
in performance. Effectiveness is defined as the degree to which something is successful in producing a desired result; success
QMS GONE WRONG: EXAMPLE OF THE HUBBLE TELESCOPE
No better quality pictures: the lens was not cut to the requirements of NASA. Several things went
wrong: the supplier cut it wrong but nobody tested it,… took a lot of money and time.
2. QMS STANDARDS
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
ISO = an international organization that determines standards. It is a collaboration between 163
countries and was established in 1926 as ‘International Federation of the National Standardizing
Associations (ISA)’. They develop standards for several industries. Some are QMS but also food
safety, environmental management systems…
, - ISO 9001:2015
o International standard for quality management systems (QMS)
o Can be applied to any organisation, regardless of industry/sector
o Using ISO9001, an assessment can be made whether an organisation is able to satisfy
demanded (customer) requirements.
- ISO 13485:2016
o Requirements for QMS for design and production of medical devices
o Harmonised with ISO 9001
GMP – EU AND FDA
This is based on regulations applied to manufacturers of pharma products. They have to follow the
GMP. There are differences between EU and America (FDA). Both have developed a GMP guidance.
Both have regulations with QMS requirements included regarding to GMP of pharma products.
However, some things are missing. Quality control (QC) is testing, whereas Quality
assurance (QA) is more high-level on the production level. Quality management is
then more on an organization level. GMP is between QC and QA as it talks about
quality control testing and production, but the part between GMP and QMS misses
from those GMP guidances:
- Other departments (only production and QC is included)
- Internal communication - Customer satisfaction
- Efficiency - Role of leadership, policy and objectives
- Business performance monitoring - Continual improvement
The GMP therefore are not sufficient to achieve a QMS. You need additionally some other standards
to implement: both the EU and FDA refer to ICH Q10 for those aspects of the QMS.
ICH: INTERNATIONAL CONFERENCE ON HARMONISATION
= Former ‘International Conference on Harmonisation’. It is focused on delivery of harmonised
guidelines for global pharmaceutical development.
- In 1960, 1970: large increase in laws and regulations about reporting and evaluating data on
quality, safety and efficacy of new pharmaceuticals
- Large variation in requirements between countries
➔ Urgency for rationalisation & harmonisation increased
- The European Commission pioneered (EU, Japan & US)
- 1990: government and industry representatives from EU, Japan and US established ICH
- Safety, Quality & Efficacy
o Quality guidelines: how you manufacture products
o Safety guidelines: preclinical aspects, GLP
o Efficacy guidelines: focused on clinical aspects, GCP
o Multidisciplinary guidelines: between Q, S and E
- ICH Q10: pharmaceutical quality system
