This topic is included in M.pharm (Pharmaceutical quality assurance) Sub name: quality management system Semester: 1st Unit: 2

1. QUALITY MANAGEMENT SYSTEM
ICH Q 10 GUIDELINE
(pharmaceutical quality system)
Presented by:
V. Aishwarya
M pharm 1st year
( pharmaceutical Quality
Assurance)
Annamalai university
submitted to:
Dr . K Devi ,M .pharm.., ph. D
Assistant professor,
Annamalai university
1

2. ICH Q10 GUIDELINE OUTLINE:
1) INTRODUCTION
2) PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM
 SCOPE
 RELATIONSHIP OF ICH Q10 TO REGIONAL GMP REQUIREMENT
 RELATIONSHIP OF ICH Q10 TO REGULATORY APPROACHES
 OBJECTIVES OF ICH Q10
 ENABLERS
 DESIGN AND CONTENT CONSIDERATION
 QUALITY MANUAL
3) MANAGEMENT RESPONSIBILITIES
4) CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY
 LIFE CYCLE STAGE GOALS
 ELEMENTS OF PHARMACEUTICAL QUALITY SYSTEM
5) CONTINUAL IMPROVEMENT OF PHARMACEUTICAL QUALITY SYSTEM 2

3. 1) INTRODUCTION:
 ICH is the short form of “International council
for harmonization” of technical requirements for
registration of pharmaceuticals for human use.
 ICH Q10 ( pharmaceutical quality system) focus
to encourage a paradigm shift from discrete GMP
compliance procedures at every stage of the
product lifecycle to a extensive quality systems
approach over the lifecycle of the product.
3

4.  ICH Q10 describing a model for an effective
pharmaceutical quality management system
for the pharmaceutical industry.
 ICH Q10 demonstrates industry and regulatory
authorities support of an effective
pharmaceutical quality system to enhance
quality and availability of medicines around
the world in the interest of public health.
4

5.  The ICH is to measure international harmonization
of technical requirements to ensure that safety,
efficacy, high quality medicines are developed and
registered in the most efficient and cost effective
manner without breakage.
5

6.  It is a management system to direct and control a
pharmaceutical company with regard to quality
 ICH is a joint initiative involving both
regulators and research based industry
representative of the EU, Japan and the US in
scientific and technical discussions of the
testing procedures required to assess and ensure
the safety, quality, efficacy of the medicines.
6

7.  It is based on three important aspects:
ICH Q7 (GMP) ICH Q8(PHARMACEUTICAL
DEVELOPMENTS)
ICH Q9(QUALITY RISK
MANAGEMENT)
7

8. ICH Q10 PHARMACEUTICAL QUALITY SYSTEM MODEL
8

9. 2) SCOPE:
 Applicable to systems for development and
manufacturing of APIs
 drug products
 biotechnology products.
 biological products throughout product lifecycle.
 There are 4 stages of guidelines.
9

10. scope
Pharmaceutical
development
Technology
transfer
Commercial
manufacturing
Product
discontinuation
10

11. Pharmaceutical development:
 In the pharmaceutical development phase, the
goal is to design products and plan the steps in
manufacturing.
 Your organization will focus on meeting the
needs of patients, caretakers, and healthcare
professionals
11

12.  The planning activities conducting phases are:
•Developing drug substances
•Developing formulations, that include both
container and closure systems
•Developing analytic methods
•Developing manufacturing processes and plans
for the scale-up
12

13. Technology transfer:
 In the technology transfer phase, the goal is to transfer
knowledge about both processes and products from the
development phase to the manufacturing phase.
 The technical activities associated with this phase are:
• Transfer of products from development to manufacturing
• For marketed products, transfer between manufacturing
and testing sites
13

14.  With the help of Simpler QMS, you will
avoid all paper trails and access unmatched quality
process coverage.
 You will be able to easily track your documents
between departments and facilities.
14

15. Commercial manufacturing:
 The goal of the commercial manufacturing phase of the
ICH Q10 pharmaceutical quality system is to help your
organization manufacture products through a process of
continuous improvement .
 In this phase, the technical activities that your organization
will perform are:
• Provide for facilities, equipment, and utilities
• packaging materials and labels
• Store, release, or distribute the manufactured products
15

16. The enhanced features of Simpler QMS will
help you such as :
1. Distribution of work instructions
2. Report generation
3. Escalation of overdue activities
16

17. Product discontinuation:
 In this phase, your organization will supervise the end of a
product’s lifecycle.
 The technical activities associated with this phase are:
• Management of document retention and sample retention
• Performing continuous product evaluation and reporting
 The Simpler QMS software helps your organization to track
all your QMS documentation, processes, protocols, and
products. 17

18. Relationship of ICH Q10 to regional GMP
requirement:
 ICH Q7 and ISO are the foundation of ICHQ 10
 ICH Q10 is intended to be used together with GMP
requirements.
 GMPs do not cover all stages of product.
 This guidance is aimed to promote continual
improvement across the entire product lifecycle..
18

19. Relationship of ICH Q10 to regulatory approaches:
 Regulatory approaches for a specific product or
manufacturing facility should be commensurate with the
level of product, process understanding ,results of quality
risk management , effectiveness of pharmaceutical quality
system.
 When implemented the effectiveness of the
pharmaceutical quality system can be normally evaluated
during regulatory inspection at manufacturing site
19

20. OBJECTIVES OF ICH Q10:
 Implementation of the Q10 model in three main
objectives :
1) Achieve
product
realization
2) Establish
and maintain
a state of
control
3) Facilitate
continual
improvement
20

21. 1) Achieve product realization:
To establish ,implement ,and maintain a system that
allows the delivery of products with the quality
attributes to meet the :
 needs of patients
 health care professionals
 regulatory authorities (including the compliance with
approved regulatory filings)
 Other internal and external customers. 21

22. 2) Establish and maintain a state of control:
 To develop and use effective monitoring and control
systems for process performance and product quality
thereby providing assurance of continued suitability and
capability of processes.
 Quality risk management can be useful in identifying the
monitoring and control systems.
22

23. 3)Facilitate continual improvement:
To identify and implement appropriate :
product quality improvements
 process improvements
 variability reduction
 innovations
pharmaceutical quality system enhancements.
 Thereby increasing the ability to fulfil a pharmaceutical
manufacturer own quality needs consistently.
23

24. Enablers :
knowledge management and quality risk
management will enable a company to
implement ICH Q10 effectively and
successfully.
Knowledge management
Quality risk management
24

25. 1)knowledge management:
Product and process knowledge should be
managed from development through the commercial
life of the product up and including product
discontinuation.
Knowledge management is a systematic approach
to acquiring, analyzing, storing, disseminating
information related to products, manufacturing
processes and components. 25

26. 26

27. 2) Quality risk management(Q9);
 Quality risk management is integral to an effective
pharmaceutical quality system
 It can provide a proactive approach to identifying,
scientifically evaluating, controlling potential risk to
quality.
27

28. Design and content consideration:
 The design, organization and documentation of
the pharmaceutical quality system should be well
structured and clear to facilitate common
understanding.
 The elements of ICH Q10 should be applied in a
manner that is appropriate and proportionate to
each of the product lifecycle stages, recognizing
the different goals and knowledge available for
each stage. 28

29.  The size and complexity of the company’s
activities should be taken into consideration
when developing a new pharmaceutical quality
system or modifying an existing one.
 While some aspects of the pharmaceutical
quality system can be company wide and others
site specific, effectiveness of the pharmaceutical
quality system is normally demonstrated at the
site level. 29

30.  Management responsibilities described in section 3
should be identified within the pharmaceutical quality
system.
 The pharmaceutical quality system should include the
following elements as described in section 4
 Process performance and product quality
monitoring
 Corrective and preventive action
 Change management
 Management review
30

31. QUALITY MANUAL:
 Quality manual or equivalent documentation approach
should be established and should contain the description of
the pharmaceutical quality system
 The description should include:
 The quality policy
 The scope of the pharmaceutical quality system
 Identification of the pharmaceutical quality
system processes as well as their sequences
,linkage and interdependencies.
 Process maps and flow charts can be useful tools31

32. What will a quality manual provide to a company?
 overall it provides evidence of what specific controls are implemented to
ensure product /service quality.
Who will benefit?
 Customers
 Suppliers
 Employees
 The company
A quality manual should be:
 Address all quality system elements
 Contain or refer to quality procedures “documentation”
Benefits of documentation quality manual:
The key is to move towards:
1) consistently repeating the best practices
32

33. Basic quality manual outline :
 Introduction
 policy and objectives
 Definitions
 Quality system
 Organization
 Authority and responsibilities
 Compliance
 Internal review and audit
 Documentation and change
 Purchasing
 Inspection and testing
 training
33

34. 3) MANAGEMENT RESPONSIBILITY:
Leadership is essential to establish and maintain a company wide
commitment to quality and for the performance of the pharmaceutical
quality system.
 Management commitment
 Quality policy
 Quality planning
 Resource management
 Internal communication
 Management review
 Outsourced activities
 Change to product ownership
34

35. Management commitment:
senior management has the ultimate responsibility to ensure an
effective pharmaceutical quality system is in place to achieve the
quality objectives
 Roles
 responsibilities
 authorities are defined, communicated and implemented
throughout the company
Management should :
 Demonstrate strong and visible support.
 Ensure availability of timely and effective communication
and escalation process.
35

36.  Define role, responsibilities and authorities.
 Should participate in design, implementation, monitoring and
maintenance.
 Ensure independent quality unit
 Conduct management reviews
 Advocate continual improvement
 Appropriate resources
QUALITY POLICY:
 Senior management should establish a quality policy that describes
the overall intentions and direction of the company related to quality.
 continual improvement.
36

37.  Communicate at all levels
 Review is periodically for continuing effectiveness
Quality planning:
 Defining and communicating quality objectives
 Quality objectives should align with strategies
 Should provide resource and training to achieve objectives
Resource management:
 Determine and provide adequate and appropriate
resources(human, financial, materials, facilities, equipment)
 Ensuring appropriate application of these resources
37

38. Internal communication:
 Management should ensure appropriate communication processes
are established and implemented within the organisation.
 The process should ensure flow of correct information between the
levels.
 Ensure appropriate and timely escalation of certain quality issues
Management review:
 Conduct review to ensure suitability and effectiveness of PQS
 Asses the conclusion of process performance and product quality.
38

39. Control and outsourced activities and materials:
 Assess suitability of the materials.
 Establishing written agreements
 Monitoring and reviewing their performance
 Monitoring the incoming materials
Change in product ownership:
 Transfer of essential information 39

40. 4) CONTINUAL IMPROVEMENT OF PROCESS
PERFORMANCE AND PRODUCT QUALITY
(life cycle stage goals)
This section describes the lifecycle stage goals and the
four specific pharmaceutical quality system elements .
1) Pharmaceutical development
2) Technology transfer
3) Commercial manufacturing
4) Product discontinuation.
40

41.  Pharmaceutical quality system elements:
PQS
ELEMENTS
PROCESS
PERFORMANCE
AND PRODUCT
QUALITY
MONITORING
CORRECTIVE
ACTION AND
PREVENTIVE
ACTION
MANAGEMENT
REVIEW
PROCESS
CHANGE
MANAGEMENT
SYSTEM
41

42. Process performance and product quality
monitoring system:
 Should use quality risk management approach for
establishing control strategy.
 Includes parameters and attributes related to drug
substance, input materials, facility and equipment
operating conditions, in process control, finished
product specification, methods and frequency of
monitoring
 Provide tools for measurement of parameters
42

43. Analyses the parameters and attributes
Identify source of variation
Include feedback on product quality ( both internal
and external)
Provide knowledge to enhance process
understanding design space and approach to process
validation.
43

44. Corrective action and preventive action(CAPA)
system:
 Should have system for implementing CAPA
resulting from investigations of complaints ,
deviations , recalls, audits.
 Emphasis on root cause determination with structed
approach
 Level of effort and formality be commensurate
with level of the risk. 44

45. Change management system:
 Quality should be utilized to evaluate the change
with efforts.
 Evaluate the change to regulatory filling.
If working in design space it does not require
regulatory filling update:
 Should be evaluated by expert teams( regulatory
affairs)
45

46. Management review process:
 Follow up actions from previous review
 Should include results of regulatory inspection ,
audit finding commitment to authorities
 Review of complaint and recalls
 Conclusion of process performance and product
quality
 Identify the improvements
46

47. 5) Continual improvement of pharmaceutical
quality system:
47

48. Management review:
Measure achievement of PQS objectives
Assessment of performance indicators for
effectiveness like:
• Complaint
• recall
• changes
• self assessment
• inspections.
48

49. Monitoring of internal and external factors:
 Quality issues that can impact the PQS
 Innovations that might enhance the PQS
 Change in product ownership
Outcome of management review:
 Improvement to PQS and related processes
 Allocation and reallocation of resources
 Revision of quality policies and objectives
 Escalation of quality issues. 49

50. Reference:
 Text book of quality management system peeve(peevee book)
 ICH harmonised tripartite guideline.
 https://www.simplerqms.com/ich-q10-pharmaceutical-
quality-system/
 International conference on harmonization ICH Q10:
pharmaceutical quality system ay 2007 / June 2008
 Guidance for industry : quality system approach to
pharmaceutical GMP regulations, September 2006
 https://www.slideshare.net/mb3594/ich-q10-142747701
50

51.  https://www.slideshare.net/ramu9682/ich-q10-
pharmaceutical -quality-system-52729506
 https://www.ema.Europa.eu/en/documents/scientific-
guideline/international-conference-harmonisation-technical-
requirements-registeration-pharmaceuticals-human_en.pdf
 https://en.m.Wikipedia.org/wiki/international_council_for_h
armonisation_of -technical-requirements-for-
pharmaceuticals-for-human-use.
 https://database.ich.org/sites/default/files/Q10_presentatio
n.pdf
 https://pubmed.ncbinim.nih.gov/34773177/ 51

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