Pharmaceutical Quality Management System

PREPARED BY- DHAWAL RAJDEV
M.PHARM (QA)
RK University
1

Basics of quality
management system
2

Basics of quality management
system
 Quality word oriented from Latin word
‘Qualitus’ it means General excellence OR
distinctive feature.
 Quality- a standard of how good something
is as measured against other similar
things.( by OXFORD dictionary)
 If we try to analyse definition some
common words like...
3

1. standard
2. Measurement
3. Goodness
4. comparison
 Most simple definition of quality is
‘fitness for use’
 The customer or user is at focous. if
customer or user is happy and satisfied
with our product or service than product
or service is called good quality.
4

 It must be remember that the quality is not
the job of only a single person or single
department but, it is responsibility of whole
organization.
 Quality of Product and service is
measurable, managerial, technological and
stastical feature of organization.
 There are so many quality gurus who are
first get aware about need if quality and
started the evaluation of quality
management at industrial level. some of
them are as follows....
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1.Dr. Joseph Juran
 He belives that quality there are no
shortcut of quality, it is neither an
accidental not it happens overnight.
Quality must be planned.
 Aspects of Dr. Joseph Juran:
1. Quality planning
2. Quality control
3. Quality improvement
6

2.Dr. W. Edward Deming
 He is well known for the work that he
carried out in Japan in the field of quality.
1. Adopt anew policy a transformation of the
style of management
2. Create purpose of continuous improvement in
product and services
3. Morden methods for training the employs
4. Breakdown barriers between department
5. Create a structure of organization which
allows every one to work towards
transformation
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3.Philip B. Crosby
1. The definition of quality is to
conformation requirements.
2. The system to be used is preventive of
errors
3. The performance standard is zero
defect
4. Measurement is based on cost of
quality.
8

 Dimensions of Quality
 Performance
 Feature
 Reliability
 Perceived quality
 Aesthetics
 Durability
 Conformance
 serviceability
9

Total Quality
Management (TQM)
10

Introduction
 „Total –Made up of the whole(or)
Complete.
 „Quality –Degree of Excellence a product
or service provides to the customer in
present and future.
 „Management –Act , art, or manner of
handling , controlling, directing, etc.
 TQM is the art of managing the whole to
achieve excellence
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 "TQM is a management approach for an
organization, centered on quality, based
on the participation of all its members
and aiming at long-term success
through customer satisfaction, and
benefits to all members of the
organization and to society."
 Definition:
Total Quality Management(TQM) is a
management strategy aimed at
embedding awareness of quality in all
organizational processes.
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 TQM requires that the company maintain
this quality standard in all aspects of its
business. This requires ensuring that
things are done right the first time and that
defects and waste are eliminated from
operations.
 Characteristics :
• Technological
Strength, hardness, surface finish
• Time – oriented
Reliability, maintainability - availability
• Contractual
Guarantee. Provision
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Goal of TQM
Define
measure
analyseimprove
control
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Six basic concepts of TQM
1. A committed and involved management
to provide long term top – to – bottom
organization support.
2. An unwavering focus on the customer,
both internally and externally.
3. Effective involvement and utilization of
the entire work force.
4. Continuous improvement of the
business and production
16

5. Treating suppliers of the business and
production process.
6. Establishing the performance measures
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Control
Culture
Customer focus
Co-operation
Continuous
improvement
Commitment
18

 Total Quality Management and
Continuous Improvement
 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.
19

Continuous Improvement
versus Traditional Approach
 Traditional Approach
1. Market share focus
2. Individuals
3. Focus on who and
why
4. Short term focus
5. Product focus
6. Innovation
7. fire fighting
 Continuous Improvement
1. Customer focus
2. Cross functional terms
3. Focus on what and how
4. Long term focus
5. Process improvement
6. Incremental
improvement
7. Problem solving
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 Quality Cost
 Prevention Cost –Planning, Document, Control, Training
 Appraisal cost- inspection test installation Calibration, M/c
Depreciation, Reports & Rejects.
 Internal Failure Cost – Scraps, Repair Rework, Design Changes,
Defect Failure Analysis, Retests &
Re-Inspection, Downgrading, Down Time.
 External Failure Cost – Complaints, Goodwill, Failures,
Services & Replacement, Guarantee
& Warranty, Compensation, Recall,
Loss of Sales, Seconds Sales.
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Benefits of quality
 Improved quality
 Employee participation
 Less migration of employee
 Team work
 Internal external customer satisfaction
 Productivity with connectivity
 Profibility & increase market share
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 Six sigma is a business statistical Strategy.
 Is to identifying defects and removing them from
the process of products to improve quality.
 A defect is defined as any process output that
does not meet customer specifications.
 Statistical measure to objectively evaluate
processes.
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 The Six sigma was founded by Motorola in the
1970s.
 Out of senior executive Art Sundry's criticism of
Motorola’s bad quality.
 They founded a connection between increases
in quality and decreases in costs of production.
 Bill Smith, “Father of six sigma” introduce this
quality improvement Methodology to Motorola.
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• Quality management program developed by
Motorola in the 1980s.
• Management philosophy focused on
business process improvements to:
Eliminate waste, rework, and mistakes
Increase customer satisfaction
Increase profitability and
competitiveness
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DMAIC DMADV
• Define
• Measure
• Analyze
• Improve
• Control
• Define
• Measure
• Analyze
• Design
• Verify
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Define : company must identify the customer and which
type of a product and hope from it. These are analyze by
using flow cause/effect diagrams, check sheets, pareto
analysis.
Measure : company will collect the baseline data to
determine where the process stands as compare to
where it needs to be. And also see the critical to quality
characteristics an estimate current process capability.
Then find out the current sigma level according to those
identified characteristic that are mostly important to the
customer
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DMAIV cont….
Analyze : this shows the amount of improvement
necessary to make the Critical to quality
characteristics the best in the industry. For this
phase company use some descriptive statistical
methods like mean, mode, median…etc.
Improve : Implement the suggested improvements
in this phase And also test possible solutions to
the process problem. Collect data from the all
possible solutions and test them on a small scale
and run a cost/benefit analysis of implementing
the solution. Then choose the best solution and
create a plan for implement the solution.
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30
Improvement cycle
• PDCA cycle
Plan
Do
Chec
k
Act

DMAIV cont….
Control : measures are implemented to ensure
improvements are maintained. To monitor the process
improvements, basically use tools like statistically
process control charts. These charts have three limits,
the center line for the average. Monitor the process to
ensure that the process is in the control limits.
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This method is also called DFSS (Design For
Six Sigma)
And have five phases,
Define design goals that are consistent with
customer demands and the enterprise strategy.
Measure and identify CTQs (characteristics that
are Critical To Quality), product capabilities,
production process capability, and risks.
Analyze to develop and design alternatives, create
a high-level design and evaluate design capability
to select the best design.
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 Design details, optimize the design, and plan for design
verification. This phase may require simulations.
 Verify the design, set up pilot runs, implement the
production process and hand it over to the process
owner(s).
DMADV cont….
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Between -1 to 1 standard deviation = 68.3%
(2/3)
Between -2 to 2 standard deviation = 95.5%
Between -3 to3 standard deviation = 99.7%
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•Executive Leadership (CEO and other top
level managers)
•Champions (act as the leaders of black belts.
And also )
•Master Black Belts (chosen by champions,
give their full effort to six sigma. Help to
champions and guide the Black belts and
green belts).
•Black belts (working under Master Black
Belts, they are applying six sigma to specific
projects).
•Green Belts (Working under the black belts).
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Implemented Methodologies
Total Quality
Management
Zero
defects
Quality
Control
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Focus of Six Sigma
• Accelerating fast breakthrough
performance
• Significant financial results in 4-8
months
• Ensuring Six Sigma is an extension of
the Corporate culture, not the program
of the month
• Results first, then culture change!
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• There is nothing new. It only proves defects and defectives
counts offer tangible, measurable results.
•It is corrective action system rather than taking a
preventive and proactive approach to problems.
•It is merely about appraisal system and that appraisal
programs aren’t useful. In realty, appraisals are great tools
for identifying and tracking improvements, which is critical to
any project.
•Critics have suggested that Six Sigma did not bring quality
improvement in all the organizations where it was
implemented.
It depends on the tools and authorizations.
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Management philosophy of quality
Components of Six Sigma are
people power and process power
Define, Measure, Analyze,
Improve, Control
Criticisms
Executive Leader, Champion,
Master Black Belt, Black Belt, and
Green Belt
Statistical target of six sigma or 3.4
defects in one million opportunities
Summary
40

International Organisation for
standardization (ISO)
 A network of national standardization
bodies from over 160 countries with
Nigeria inclusive.
 Based in Geneva Switzerland.
 Standard Organisation of Nigeria (SON)
is a Technical Committee (TC) in ISO,
meaning participates fully in developing
ISO standards.
42

ISO management
standards
Selected standards that companies can be
certified for.
ISO 9001
Quality
ISO 22000
Food safety ISO 22301
Business
continuity
ISO 20000
IT services
ISO 14001
Environment
OHSAS 18001
Health and
Safety
ISO 28000
Supply chain
Security
ISO 27001
Information
security
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ISO 9001:2008 (QMS)basic
principles
 Principle 1 – Customer focus
 Principle 2 – Leadership
 Principle 3 – Involvement of people
 Principle 4 – Process approach
 Principle 5 – System approach to management
 Principle 6 – Continual improvement
 Principle 7 – Factual approach to decision making
 Principle 8 – Mutually beneficial supplier
relationships
It is upon these principles that an organization can imbibe a
sound quality system.
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Principle 1 - Customer focus
Pragmatically, a quality product centers on meeting
customers current and future requirements in
the needed form, time and place in synchrony with
the company’s policies and objectives.
Customer satisfaction
Employee’s Management
responsibility responsibility
Customer requirements
QMS
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 Application and Benefits
of Principle 1
what needs to be done
 Management must be committed.
 Consistent research into
customers needs and
expectations.
 Measuring customers satisfaction
with prompt action taken.
 Company’s objectives and
policies must be linked with
customers requirements and
interest of other parties(financers,
local communities).
 All employees must be aware of
customers needs and
expectations.
 Strategically managing customers
relationship.
what will happen?
 Increased market share.
 Efficient and effective use of
company’s recourses geared
towards customers satisfaction.
 Increased customer trust and
loyalty
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 Principle 2 - Leadership
Application
 Perfect understanding of
the organization short
and long term goals and
objectives.
 Setting realistic and
practicable targets.
 Make the needs of all
stakeholders a focal
point.
 Maintain a trustful work
ambience and not a
fearful environment.
 Positive contributions
must be encouraged.
Benefits
 More enthusiastic
workers.
 Increased employee
loyalty
 Effective communication
system is enabled.
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Principle 3 - Involvement of
the peopleApplications
 A sense of belonging
should be created in
people that has direct
and indirect link with the
company.
 People should be made
to understand that their
opinion counts.
 People openly
discussing problems
and issues.
 People identifying
constraints to their
performance.
Benefits
 Employees shows more
commitment towards
achieving organization
goals and objectives.
 Innovation and creativity
within the organization.
 People show more
interest in continuous
improvement.
48

Principle 4 - Process
Approach
Input Output
Customers
(and other
interested
parties)
Customers
(and other
interested
parties)
Management
responsibility
Resource
management
Product
realization
Measurement,
analysis and
improvement
Requirement
s Satisfaction
Continual improvement of the quality
management system.
49

What do we need to do?
 Highlighting the activities
necessary to obtain a desired
output
 Establishing clear responsibility
and accountability for managing
key activities
 Analyzing and measuring of the
capability of key activities
 Identifying the interfaces of key
activities within and between the
functions of the organization
 Focusing on the factors such as
resources, methods, and
materials that will improve key
activities of the organization
 Evaluating risks, consequences
and impacts of activities on
customers, suppliers and other
interested parties.
Consequences
 Effective usage of available
recourses
 Cost of production is reduced due
to clear definition of activities
 Focus is given to opportunities
that will cause continuous
improvement in the system.
50

Principle 5 - System Approach to
Management
System = combinations of entities
(processes)that works dependently and
interrelated with each other and becomes a
culture over a period of time.
Management
responsibility
Measurement,
analysis and
improvement
Product
realization
Resource
management System
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Requirements
 Conceiving a structured system that
meets organization objectives
efficiently and effectively.
 Understanding and defining the
interrelationships and
interdependencies between each
processes within the system.
 Devising ways to harmonise and
integrating the related processes.
 Providing clear definitions of
individual roles and responsibilities
towards achieving a common
objectives to prevent cross-
functional barriers.
 Reconciling the organization targets
with the resources available to
know possible limits so as to
fashion a way out.
 Targeting and defining how specific
activities within a system should
operate.
 Continually improving the system
through measurement and
evaluation.
What will happen?
 Integration and alignment of
the processes that will best
achieve the desired results
 Ability to focus effort on the
key processes
 Providing confidence to
interested parties as to the
consistency, effectiveness
and efficiency of the
organization.
52

 Principle 6 - Continual
ImprovementHow do we achieve this?
 Frequent internal audit of the quality system
identifying weak spots and areas that needs
improvement.
 Employing a consistent organization-wide
approach to continual improvement of the
organization’s performance
 Providing people with training in the
methods and tools of continual
improvement
 Making continual improvement of products,
processes and systems an objective for
every individual in the organization
 Establishing goals to guide, and measures
to track, continual improvement
 Recognizing and acknowledge and
improvements.
Benefits
 Performance advantage
through improved
organizational capabilities
 Alignment of improvement
activities at all levels to an
organization’s strategic
intent
 Flexibility to react quickly to
opportunities.
53

 Principle 7- Factual approach
to decision
making
How?
 Conducting frequent market
survey and market intelligence.
 Customer dissatisfactions be
treated generically, sequel to
extensive market survey to
generate valid information.
 Ensuring that data and
information are sufficiently
accurate and reliable
 Making data accessible to those
who need it
 Analyzing data and information
using valid methods
 Making decisions and taking
action based on factual analysis,
balanced with experience and
intuition.
Benefits
 Prevents impulsive decision
making that could dissatisfy
majority of the customers.
 Only informed decisions will be
made generically.
 An increased ability to
demonstrate the effectiveness of
past decisions through reference
to factual records
 Increased ability to review,
challenge and change opinions
and decisions.
54

 Principle 8 - Mutually
Beneficial Supplier
RelationshipsHow ?
 Establishing relationships that
balance short-term gains with
long-term considerations.
 Pooling of expertise and
resources with partners.
 Identifying and selecting key
suppliers.
 Clear and open communication
 Sharing information and future
plans
 Establishing joint development
and improvement activities
 Inspiring, encouraging and
recognizing improvements and
achievements by suppliers.
Benefits
 Increased ability to create value
for both parties
 Flexibility and speed of joint
responses to changing market or
customer needs and expectations
 Optimization of costs and
resources.
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Conclusion
All discussed principles are the core
attributes on which ISO 9001:2008 are
based upon, and it is therefore
imperative that to meet up with
International standards, we at ACSK
should strive to align our operations with
these principles to foster a better
competitive advantage both on local and
international front.
56

Recommendations
1. GAP analysis of the status quo.
Current state Desired / future state
of the company
2. Assembling a Quality Management Team (QMT)with
following responsibilities:
 Performing timely frequent internal audit of the quality
management status of the company.
 Establishing a corrective and preventive action plan for the
diagnosed nonconformities with ISO 9001.
 Piloting and Charting the course and directions towards the
company certification for ISO 9001.
3. Research and Development (R&D)department be
considered as a long-term competitive strategy.
GAP
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Are you ready for changes?
Prepared by: Reza Seifollahy
Background
 First published in 1987, ISO 9000 has
consistently been ISO’s most popular
series of standards.
 building on 25 years of success, ISO
technical committee ISO/TC 176,Quality
management and quality assurance,
subcommittee SC 2, Quality systems,
is busy laying the groundwork for the
next generation of quality management
standards.
59

Are you ready for Changes?
Prepared By: Reza Seifollahy
ISO 9001 revisions since beginning
1987
1994
2000
2008
2015
Revisions
60

ISO 9000 Series
 They have:
 Consistently been ISO’s best-selling
standards;
 Firmly established a common platform and
language for organizations to discuss quality;
 By defining requirements in ISO
9001, Quality management systems, that
give a base-level confidence in an
organization’s ability to provide conforming
products, they have facilitated world trade.
61

Are you ready for changes?Latest ISO 9000 series
ISO9001:2008 is
Quality management
systems –
Requirements
Previous
Add latest Versions
ISO9004:2009 is
Managing for the
sustained successof
an organization – A
quality management
approach
62

Looking to the Future
s
Are you ready for the Changes?
The vision of standard preparation
committee is looking a head to the
needs of future.
63

Basic Principles are revisited from eight to seven
REVISION OF QUALITY
PRINCIPLES
Prepared by: Reza Seifollahy 64

4. Process
Approach
Quality Principles
The Revised Quality
Principles
Are you ready for the changes?
65

ISO 9001:2015 Time lineAre you ready for changes?

10 Clues
1. Scope
2. Normative references
3. Terms and definition
4. Context of organization
5. Leadership
6. Planning
7. Support
8. Operations
9. Performance Evaluation
10. Improvement
67

Proposed Clauses:
1. Scope
2. Normative references
3. Terms and Definitions
1. Organization
2. Interested Party (preferred term)
3. Requirement
4. Management System
5. Top management
6. Effectiveness
7. Policy
68

Proposed Clauses:
8. Objective
9. Risk
10. Competence
11. Documented information
12. Process
13. Performance
14. Outsource (verb)
15. Monitoring
16. Measurement process
17. Audit
69

Proposed Clauses:
18. Conformity
19. Non-conformity
20. Correction
21. Corrective Action
22. Continual improvement
70

4. Context of The Organization
1. Understanding the Organization and its context
2. Understanding the needs and expectations of
interested parties
3. Determining the scope of the quality management
system
4. Quality Management System
1. General
2. Process Approach
71

Are you Ready for the changes?
5. Leadership
5.1 Leadership & Commitment
5.2 Quality Policy
5.3 Organizational Roles,
Responsibilities & Authorities

Are you Ready for the changes?
6. Planning
6.1 Actions to address risks &
opportunities
6.2 Quality objectives & planning
To achieve them
6.3 Planning of changes

7. Support
7.5
7.3
7.4
7.1Resources
Competence
7.2
Awareness
Documented
Information
Communication
74

7.5 Documented Information
7.5
General
Creating &
Updating
Control of
Documented
Information
75

8. Operation
1.Operational Planning & Control
2.Determination of Market needs & interactions
with customers
3.Operational Planning process
4.Control of external Provision of Goods &
Services
5.Development of Goods & Services
6.Production of goods and provision of services
7.Release of goods and services
8.Nonconforming goods & services
Are you ready for the changes
76

The new clause 8 is covered the
requirements of clause 7 in last
version.
Clause 7.3 design & development in
previous versions is simplified to
clause 8.5 development of goods and
services. The new standard resolved
many problems related to design and
development.
77

9. Performance evaluation
9.1.
9.2.
9.3.
Monitoring, measurement , analysis and
evaluation
9.1.1.General, 9.1.2.customer satisfaction, 9.1.3.
Analysis & evaluation of data
Internal Audit
Management Review
78

10.1 Nonconformity and
Corrective Action
10.2 Improvement
10. Continual Improvement
79

Management Service Division
ISO 14001:2004 Overview
80

 It was due for revision, ISO requires that all
management system standards undergo
periodic revision
 To enhance compatibility with ISO
9001:2000
 Revision allows opportunity to clarify
requirements in the 1996 version and
incorporate needed changes
Why was ISO 14001
revised?
81

4.1 General Requirements
The organization shall establish, document,
implement, maintain and continually improve an
environmental management system in accordance
with the requirements of this International Standard
and determine how it will fulfill these
requirements.
The organization shall define and
document the scope of its
environmental management system.
ISO 14001:2004
82

Environmental Policy
ISO 14001: 2004
Top management shall define the organization's
environmental policy and ensure that, within the
defined scope of its environmental
management system, it:
a) is appropriate to the nature, scale and
environmental impacts of its activities, products
and services,
b) includes a commitment to continual improvement
and prevention of pollution,
83

ISO 14001: 2004
c) includes a commitment to comply with
applicable legal requirements and with
other requirements to which the
organization subscribes which relate to
its environmental aspects,
d)provides the framework for setting and
reviewing environmental objectives and
targets,
84

ISO 14001: 2004
e)is documented, implemented and
maintained
f) is communicated to all persons
working for or on behalf of the
organization, and
g)is available to the public.
85

ISO 14001: 2004
The organization shall establish,
implement and maintain a procedure(s)
a)to identify the environmental aspects of
its activities, products and services within
the defined scope of the
environmental management system
that it can control and those that it can
influence taking into account planned or
new developments, or new or
modified activities, products and
services, and
86

ISO 14001: 2004
b)to determine those aspects that have or
can have significant impact(s) on the
environment (i.e. significant
environmental aspects).
The organization shall document this
information and keep it up to date.
The organization shall ensure that the
significant environmental aspects are
taken into account in establishing,
implementing and maintaining its
87

Objectives, targets and
programme(s)
The organization shall establish, implement and
maintain documented environmental
objectives and targets, at relevant functions
and levels within the organization.
The objectives and targets shall be
measurable, where practicable, and
consistent with the environmental policy,
including the commitments to prevention of
pollution, to compliance with applicable
legal requirements and with other
requirements to which the organization
subscribes, and to continual
improvement.
88

ISO 14001: 2004
89

When establishing and reviewing its objectives
and targets,
an organization shall take into account the legal
requirements and other requirements to
which the organization subscribes, and
its significant environmental aspects. It shall
also consider its technological options, its
financial, operational and business
requirements, and the views of interested
parties.
90

ISO 14001: 2004
91

ISO 14001: 2004
92

ISO 14001: 2004
93

ISO 14001: 2004
94

Resources, roles,
responsibility and authority
Management shall ensure the availability of
resources essential to establish, implement,
maintain and improve the environmental
management system. Resources include
human resources and specialized skills,
organizational infrastructure, technology
and financial resources.
Roles, responsibilities and authorities shall be
defined, documented and communicated in
order to facilitate effective environmental
management.
95

ISO 14001: 2004
96

The organization's top management shall
appoint a specific management
representative(s) who, irrespective of
other responsibilities, shall have defined
roles, responsibilities and authority for
a)ensuring that an environmental
management system is established,
implemented and maintained in
accordance with the requirements of this
International Standard,
97

 reporting to top management on the
performance of the environmental
management system for review,
including recommendations for
improvement.
98

Communication
With regard to its environmental aspects and
environmental management system, the
organization shall establish, implement
and maintain a procedure(s) for
a) internal communication among the various
levels and functions of the organization,
b) receiving, documenting and responding to
relevant communication from external
interested parties.
99

 The organization shall decide whether to
communicate externally about its
significant environmental aspects, and
shall document its decision.
 If the decision is to communicate,
the organization shall establish and
implement a method(s) for this
external communication
100

Documentation
The environmental management system documentation shall
include
a) the environmental policy, objectives and targets,
b) description of the scope of the environmental
management system,
c) description of the main elements of the environmental
management system and their interaction, and reference to
related documents,
d) documents, including records, required by this
International Standard, and
e) documents, including records, determined by the
organization to be necessary to ensure the effective
planning, operation and control of processes that relate
to its significant environmental aspects.
101

Internal audit
Audit programme(s) shall be planned, established,
implemented and maintained by the organization,
taking into consideration the environmental importance
of the operation(s) concerned and the results of
previous audits.
Audit procedure(s) shall be established, implemented and
maintained that address the responsibilities and
requirements for planning and conducting audits,
reporting results and retaining associated records,
— the determination of audit criteria, scope, frequency and
methods.
Selection of auditors and conduct of audits shall
ensure objectivity and the impartiality of the audit
process.
102

Pharmaceutical Quality Management
ICH Q-10 103

 ICH Q-10
 ICH Q10 demonstrates industry and regulatory
authorities’ support of an effective
pharmaceutical quality system to enhance the
quality and availability of medicines around the
world in the interest of public health.
 For the purposes of this guidance, the product
lifecycle includes the following technical
activities for new and existing products:
104

 ICH Q10 provides a harmonized model for a
pharmaceutical quality system throughout the
lifecycle of a product and is intended to be used
together with regional GMP requirements
105

Pharmaceutical Development
 Drug substance development
 Formulation development (including container/closure system)
 Manufacture of investigational products
 Delivery system development (where relevant)
 Manufacturing process development and scale-up
 Analytical method development
• Technology Transfer
 New product transfers during development through manufacturing
 Transfers within or between manufacturing and testing sites for
marketed products
• Commercial Manufacturing
 Acquisition and control of materials
 Provision of facilities, utilities, and equipment
 Production (including packaging and labeling)
 Quality control and assurance
 Release
 Storage
106

 ICH Objectives
 Implementation of the Q10 model should result in
achievement of three main objectives that
complement or enhance regional GMP requirements.
 Achieve Product Realization
To establish, implement, and maintain a system that
allows the delivery of products with the quality
attributes appropriate to meet the needs of patients,
health care professionals, regulatory authorities
(including compliance with approved regulatory
filings) and other internal and external customers
107

 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
 Facilitate Continual Improvement
To identify and implement appropriate product
quality improvements, process improvements,
variability reduction, innovations, and pharmaceutical
quality system enhancements, thereby increasing the
ability to fulfill a pharmaceutical manufacturer’s own
quality needs consistently. Quality risk management
can be useful for identifying and prioritizing areas for
continual improvement
108

 Quality Risk
Management Quality risk management is integral to an effective
pharmaceutical quality system. It can provide a
proactive approach to identifying, scientifically
evaluating, and controlling potential risks to
quality.
 It facilitates continual improvement of process
performance and product quality throughout the
product lifecycle. ICH Q9 provides principles and
examples of tools for quality risk management that
can be applied to different aspects of
pharmaceutical quality.
109

 Design and Content
Considerations
 The design, organization, and documentation of
the pharmaceutical quality system should be well
structured and clear to facilitate common
understanding and consistent application
 The pharmaceutical quality system should include
appropriate processes, resources, and
responsibilities to provide assurance of the quality
of outsourced activities and purchased materials,
etc.
110

 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.
 The design of the pharmaceutical quality system
should incorporate appropriate risk management
principles.
 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.
111

 Quality Manual
 A Quality Manual or equivalent documentation
approach should be established and should contain
the description of the pharmaceutical quality system.
The description should include:
(a) The quality policy
(b) The scope of the pharmaceutical quality system.
(c) Identification of the pharmaceutical quality system
processes, as well as their sequences, linkages, and
interdependencies. Process maps and flow charts can
be useful tools to facilitate depicting pharmaceutical
quality system processes in a visual manner.
(d) Management responsibilities within the
pharmaceutical quality system
112

contents
 Data, Information & Knowledge
 Knowledge Hierarchy
 Types of Knowledge
 What Is Knowledge Management
 Why KM
 History of KM
 KM Models
 KM life cycle
114

Continue…
 Characteristics of KM in Libraries
 Terms Used in KM
115

Data, Information &
Knowledge
116

Explicit/ Tacit Knowledge-
Types
 Tacit knowledge: That type of
knowledge which people carry in their
mind, and is, therefore, difficult to
access.
 Explicit knowledge: That type of
knowledge which has been or can be
articulated, codified, and stored in
certain media.
118

Features
Explicit Knowledge Tacit Knowledge
Tangible Intangible
Physical objects, e.g. in documents or
databases
Mental objects, i.e. it's in people's
head's
Context independent Context affects meaning
Easily shared Sharing involves learning
Reproducible Not identically replicated
119

What Is Knowledge
Management
 Knowledge Management is the collection
of processes that govern the creation,
dissemination, and utilization of knowledge.
120

Why KM
 To share the knowledge, a company
creates exponential benefits from the
knowledge as people learn from it.
 To build better sensitivity to “brain drain”
 To reacting to new business
opportunities
121

 History
In 70’S
A number of management theorists
have contributed to the evaluation of
KM.
 Peter Drucker: Information and
knowledge as organizational resources
 Peter Senge: "learning organization"
 Chaparral Steel: A company having
knowledge management strategy
122

In 80’s
 Knowledge as a competitive asset was
apparent.
 Managing knowledge that relied on work
done in artificial intelligence and expert
systems.
 Knowledge management-related articles
began appearing in journals and books .
123

In 90’s Until Now
 A number of management consulting
firms had begun in-house knowledge
management programs. E.g. ADAM’s
Model
 Knowledge management was
introduced in the popular press.
 The International Knowledge
Management Network(IKMN) went
online in 1994.
124

KM Models
There are some KM Models:
 Nonaka/Takeuchi Knowledge Spiral
(1995)
 ADAM’s Model (2000-01)
 The Choo Sense-making KM Model
(1998)
 WIIG KM Model
125

Nonaka/Takeuchi knowledge
spiral (1995)
126

The Choo Sense-making KM
Model (1998)
128

Knowledge Form by WIIG
Model
130
 Public Knowledge
 Sharing Knowledge
 Personal Knowledge

CONTINUE…
 The knowledge which is explicit and can be
learned and shared, called Public
Knowledge.
 The knowledge which is an intellectual
assets and held exclusively by employees
and shared during work or embedded in
technologies, called Sharing Knowledge.
 The knowledge which is the least
accessible, but the most complete form of
knowledge. It’s usually tacit and used
without knowing, called Personal
Knowledge.
131

Knowledge Types by WIIG
Model
 Factual Knowledge
 Conceptual Knowledge
 Expectational Knowledge
 Methodological Knowledge
132

Continue…
 That type of knowledge which deals with
data and measurements, and directly
observable and verifiable, called Factual
Knowledge.
systems, concepts and perspectives, called
Conceptual Knowledge.
hypothesis, judgments and expectations
held by knowers, called Expectational
Knowledge.
133

Continue…
reasoning, strategies and decision
making methods, called
Methodological Knowledge.
134

o Knowledge management life cycle
135

Continue…
 Information Mapping: ( To categorize
the knowledge assest) Information
mapping is a process by which organizations
can identify and categories knowledge assets
within their organization.
 Information Storaging: Information
storing that contains knowledge repositories
such as databases, data warehouses, and
information centers and indicates electronic
environment of organizational memory.
136

continues…
 Information Retrieving: In this stage,
knowledge is stored and retrieved via
information retrieval systems.
137

Knowledge Using
Organizations use knowledge for three
reasons:
 Knowledge can be used for determining
organization’s work processes and
making strategies for sustainable
competitive advantage.
 Knowledge can be used for designing
and marketing product.
 Knowledge plays a critical role of
organization’s services quality
138

Knowledge Auditing
 Knowledge auditing means what amount
of knowledge can be used in
organization’s products, services and
processes.
139

Characteristics of KM in
Libraries
The characteristics of KM in libraries are:
 Human Resource Management Is the Core
of Knowledge Management in Libraries.
 The Objective of Knowledge Management
in Libraries is to Promote Knowledge
Innovation.
 Information Technology Is a Tool for
Knowledge Management in Libraries.
 The knowledge acquired must be
accumulated and converged into
knowledge warehouses of libraries.
140

Terms Used in KM
There are some terms used in KM:
 Knowledge architect
 Knowledge assets
 Knowledge bridge
 Knowledge Workers
 Knowledge Economy
141

Knowledge architect
 Knowledge architect is the staff
member who oversees the definitions of
knowledge and intellectual processes
and then identifies the technological and
human resources required to create,
capture, organize, access and use
knowledge assets.
142

Knowledge assets
 Knowledge assets, also called
intellectual capital, are the human,
structural and recorded resources
available to the organization. Assets
reside within the minds of members,
customers, and colleagues and also
include physical structures and recorded
media.
143

Knowledge bridge
 Knowledge bridge is the connection
that a KM expert builds between the
business processes and the
technological, sociological, personal,
financial, sales, creative, and customer
oriented functions of the organization.
144

Knowledge Workers
 Employees and managers who
contribute significantly to the intellectual
capital of the company are called
knowledge workers.
145

Knowledge Economy
 The knowledge economy is a term that
refers either to an economy of
knowledge focused on the production
and management of knowledge in the
frame of economic constraints, or to a
knowledge-based economy.
146

Introduction
 Quality metrics are used throughout the drugs and
biologics industry to monitor quality control systems
and processes and drive continuous improvement
efforts in drug manufacturing
 This is an explanation of how the Center for Drug
Evaluation and Research (CDER) and the Center
for Biologics Evaluation and Research (CBER)
intend to utilize submitted data and quality metrics
to help ensure that their policies and practices
continue to support continuous improvement and
innovation in the pharmaceutical manufacturing
industry. 148

 In order to achieve these goals, FDA is initiating
a quality metrics reporting program. As
described in this guidance.
 In the voluntary reporting phase of the program,
FDA expects to learn more about a limited set of
quality metrics, associated analytics, and
improve the FDA quality metrics reporting
program
 In general, FDA’s guidance documents do not
establish legally enforceable responsibilities.
The use of the word should is used to indicate
an FDA preference to promote consistent
reporting and counting of quality metrics data
149

 Quality matrix that FDA
intended to calculate
 The following set of quality metrics that FDA
intends to calculate based on industry reporting
was developed with stakeholder input. FDA used
the following selection criteria in developing the set
of data that it is inviting covered establishments to
submit
(1) Objective data to provide consistency in reporting,
(2) of the type contained in records subject to
inspection under section of the FD&C Act, and
(3) a valuable component in assessing the overall
effectiveness of a PQS, within reasonable limits,
and in a reasonable manner, while avoiding an
undue reporting burden 150

 Using reported data described in the following
section, FDA intends to calculate quality metrics for
each product and covered establishment, where
applicable:
 Lot Acceptance Rate (LAR) as an indicator of
manufacturing process performance. LAR = the
number of accepted lots in a timeframe divided
by the number of lots started by the same
covered establishment in the current reporting
timeframe.
 Product Quality Complaint Rate (PQCR) as an
indicator of patient or customer feedback. PQCR
= the number of product quality complaints
received for the product divided by the total
number of dosage units distributed in the
current reporting timeframe.
151

 Invalidated Out-of-Specification (OOS) Rate
(IOOSR) as an indicator of the operation of
a laboratory. IOOSR = the number of OOS
test results for lot release and long-term
stability testing invalidated by the covered
establishment due to an aberration of the
measurement process divided by the total
number of lot release and long-term
stability OOS test results in the current
reporting timeframe.
152

 How to Report Quality
matrix data in FDA
 Product Reporting Establishments
 Product Reporter Top Tier: If complete data supporting all
metrics were included for each covered establishment in
the manufacturing supply chain for all covered drug
products (or APIs used in the manufacture of a covered
drug product) for the full year reporting period
 Product Reporter Mid Tier: If all covered establishments in
the manufacturing supply chain for all covered products
were identified in the report, and complete quality metric
data was provided from at least one of the establishments
for each covered drug products (or APIs used in the
manufacture of a covered drug product) for the full year
reporting period
153

 Product Supply Chain Reporter: If all
covered establishments in the
manufacturing supply chain for all
covered drug products (or APIs used in
the 504 manufacture of a covered drug
product) were identified in the report
154

Site Reporting Establishments
 Site Reporter Top Tier: If complete data supporting
all metrics were included for all covered drug
products (or APIs used in the manufacture of a
covered drug product) for the full year reporting
period
 Site Reporter Mid Tier: If complete data supporting
all metrics were included for at least one covered
drug product (or API used in the manufacture of a
covered drug product) manufactured at an
establishment for the full year reporting period
155

OSHAS
 OHSAS 18000 is an international occupational
health and safety advisory service specification.
 Originally developed in early 1990’s as BS8800.
 Revised in 1999 by BSI to be more compatible
with ISO 14001.
 It comprises two parts, 18001 and 18002 and
embraces BS8800 and a number of other
publications.
 17 elements designed in parallel to ISO 14001 and
allows third-party certification/registration. 157

 An international standard like ISO 9001or ISO
14001.
 An international guideline as ICH.
 Not prescriptive –no absolute requirements;
very similar to ISO 14001.
 OHSAS 18001 was created via a concerted
effort from a number of the worlds leading
national standards bodies, certification bodies, and
specialist consultancies.
158

Documents used in creation of
OSHAS
 BS8800:1996 Guide to
occupational health and safety
management systems DNV
Standard for Certification of
Occupational Health and Safety
Management
Systems(OHSMS):1997
 Technical Report NPR 5001: 1997 Guide to an
occupational health and safety management
system. Draft LRQA SMS 8800 Health & safety
management systems assessment criteria
159

 SGS & ISMOL ISA 2000:1997 Requirements for
Safety and Health Management Systems BVQI
Safety Cert: Occupational Safety and Health
Management Standard
 Draft AS/NZ 4801 Occupational health and safety
management systems Specification with guidance for use
Draft BSI PAS 088 Occupational health
and safety management systems UNE
81900 series of pre-standards on the
Prevention of occupational risks
 Draft NSAI SR 320 Recommendation for an
Occupational Health and Safety (OH and S)
Management System
160

Participants in creation of
OSHASNational Standards Authority of Ireland. Standards Australia.
 South African Bureau of Standards. British Standards
Institution.
 Bureau Veritas Quality International.
 Lloyds Register Quality Assurance. National
Quality Assurance.
 SFS Certification.
 SGS Yarsley International Certification Services.
Asociaci?spa? de Normalizaci? Certificaci?r .
 International Safety Management Organisation Ltd.
Standards and Industry Research Institute of Malaysia.
International Certification Services .
161

OSHAS Basic
 OH & S policy Planning.
 Implementation and operation.
 Checking and corrective
action.
 Management review.
 Continual improvement.
162

OH & S Policy
 Clearly states overall OH&S objectives.
 Authorized by top management.
 Appropriate to nature & scale of OH&S risks.
 Documented, implemented, and maintained.
 Communicated to all employees. Available to
interested parties.
 Reviewed periodically.
163

OH&S Policy Commitments
•Improve health & safety performance*
Continual improvement.
“at least” comply with current applicable .
OH&S legislation and other requirements.
* Performance: measurable results of the OH&S management system,
related to the organization’s control of health and safety risks, based on
its OH&S policy and objectives. 164

OH&S Planning
Hazard identification, risk assessment, and risk
control.
•
Legal and other requirements.
Objectives
OH&S management program(s)
165

Hazard Identification, Risk Assessment &
Risk Control
Conceptually similar to environmental aspects and
impacts –target of management program(s)•
Much more detailed than 14001 approach
Assessment must address:
– routine and non-routine activities
– all personnel, including contractors and visitors
– facilities at the workplace, whether provided by the
organization or by others 166

Hazard Identification, Risk
Assessment & Risk Control
•
•
Methodology must be proactive
– in advance of process/equipment changes
– allow engineering of hazard controls during design
– implementation of controls as change occurs
Success requires strong Management of Change (MOC)
procedure
167

Hazard Identification, Risk
Assessment & Risk Control
•
•
Process overview
–identification of hazards
–evaluation of risks under current controls
–evaluation of the tolerability of residual risk
–identification of needed additional controls People are
involved
–significant risks must be controlled
–individual behaviour is a significant factor 168

Implementation &
Operation
Structure and responsibilities
Training awareness and competence
Consultation and communication
Documentation
Document and data control
Operational control
•
•
•
•
•
•
•
Emergency preparedness and response
170

Structure & Responsibilities
Documented roles, responsibilities, authorities,
and accountability
Management appointee responsible for
implementation
Resources
Managers must demonstrate commitment to
continual improvement
171

Training, Awareness &
Competence
Ensure employee awareness aAnd competence
•
Take into account differing levels of:
– Responsibility
– Ability
– Literacy
– Risk
Much of required training driven by regulation
172

Consultation & Communication
More internally focused than ISO 14001
Employee involvement and consultation
–in development/review of policies and procedures
–about changes that affect workplace safety or health
–ensuring representation in OH&S matters Buy-in,
ownership, motivation
173

Documentation & Data
•
•
Documentation of core elements
–aids employee awareness.
–shows how the various system relate.
–extremely valuable during certification process. Document
and data control procedures
–critical documents are available
–obsolete documents and data are removed
174

Operational Control
•
•
Identify operations and activities where risk requires further
control
Plan these to ensure that
– documented procedures are developed
– operating criteria specify key steps and requirements
– procedures addressing risks related to contractor goods and
services
– establish design procedures to reduce/eliminate source of
risks
175

Emergency Preparedness &
Response
Emergency response procedures to address
– identifying potential for incidents and emergencies.
– preventing and mitigating resultant illnesses and
injuries.
– responding to incidents and emergencies when they
occur.
177

Emergency Preparedness &
Response
178

Checking & Corrective Action
Performance measurement and monitoring.
Accidents, incidents, non-conformances and
corrective and preventive action.
Records and records management.
OH&S management system audit.
179

Performance Measurement &
Monitoring
•
•
•
•
•
Monitoring the achievement of objectives.
Quantitative and qualitative measures.
Proactive and reactive methods.
Records to facilitate corrective and preventive actions.
Calibration of monitoring equipment.
180

Quantitative & Qualitative
•
•
Direct Quantitative Measures
–number of lost work days following an injury.
–decibel levels of noise in a work area. Indirect
Qualitative Measures
–review of inspection logs.
–observation of a task.
–Interviews.
181

Proactive & Reactive Measures
•
•
Proactive monitoring of compliance
– routine basis, independent of any event.
– monitoring may be required by regulations
• daily equipment checks.
• periodic review of hot-work permits. Reactive monitoring
of accidents or incidents
– in response to an event or trigger
•accident investigation.
•monitoring in response to a complaint.
182

Accident, Incidents, Non-
conformances & Corrective and
Preventive Action
•
•
•
Handle, investigate, mitigate
–Accidents.
–Incidents.
–non-conformances. Corrective and
preventive actions.
Review action plans through risk assessment process.
183

Accident, Incidents &
Non-conformances
•
•
•
Handle = immediate action
–Notification.
–emergency response.
–recordkeeping to facilitate investigation. Investigation process.
–team and procedures.
–root cause analysis. People are involved
–human elements.
184

Corrective and Preventive
Action
Correct immediate problem.
•Mitigate consequences.
Eliminate or control root cause.
Prevent recurrence.
Review action plans through risk assessment process.
Communicate results and monitor.
185

Records & Record Management
•
•
Identification, maintenance, and disposition
Records must be:
– Legible.
– Identifiable.
– traceable to the activities involved.
– easily retrievable.
– protected from damage, deterioration, or loss.
– held for specified and documented retention times.
186

OH&S Management System
Audit
•
•
Determine if OH&S-MS:
–conforms with planned arrangements.
–is properly implemented and maintained.
–is effective in meeting policy and
objectives. Results provided to top
management.
•
Audit program and schedule reflect risks and previous audit results.
187

CONCLUSION
Essentially, OHSAS helps in a variety of respects... it
helps: minimize risk to employees/etc; improve an
existing OH&S management system; demonstrate
diligence; gain assurance; etc. The benefits can be
substantial.
189

What is NABL ?
 NABL specifies the general requirements
for the competence to carry out tests and
calibrations, including sampling. It covers
testing and calibration performed using
standard methods, non-standard methods,
and laboratory-developed methods.
191

 National Accreditation Board for Testing and Calibration Laboratories
(NABL) is an autonomous body under the aegis of Department of Science &
Technology, Government of India, and is registered under the Societies Act.
 NABL has been established with the objective to provide Government,
Industry and Society in general with a scheme for third- party assessment of
the quality and technical competence of testing and calibration laboratories.
 Government of India has authorized NABL as the sole accreditation body
for Testing and Calibration laboratories.
 In order to achieve this objective, NABL provides laboratory accreditation
services to laboratories that are performing tests / calibrations in accordance
with NABL criteria based on internationally accepted standard for laboratory
accreditation ISO/IEC 17025.
 These services are offered in a non-discriminatory manner and are
accessible to all testing and calibration laboratories in India and abroad,
regardless of their ownership, legal status, size and degree of independence.
 NABL has established its Accreditation System in accordance with
ISO/IEC 17011:2004, which is followed internationally. NABL also compiles to
the requirement of APLAC MR001 for the fulfillment of APLAC MRA and ILAC
Arrangements. 192

 Location of NABL Office:
NABL Secretariat is functioning from its office situated at 3rd
Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road – New
Delhi 110067.
 NABL Secretariat administers and co-ordinates all activities of
NABL including accreditation related activities for Testing and
Calibration laboratories.
 Registered Office of NABL is located in Department of Science &
Technology, Technology Bhavan, and New Mehrauli Road, New Delhi
– 110016.
 Office Timing: The working days of NABL are from Monday to
Friday. The office timings are from 9-00 a.m. to 5-30 p.m.
193

CONCEPT
 The concept of Laboratory Accreditation was developed to provide a means for third-
party certification of the competence of laboratories to perform specific type(s) of testing
and calibration.
 Laboratory Accreditation provides formal recognition of competent laboratories, thus
providing a ready means for customers to find reliable testing and calibration services in
order to meet their demands.
 Laboratory Accreditation enhances customer confidence in accepting testing /
calibration reports issued by accredited laboratories.
 The globalization of Indian economy and the liberalization policies initiated by the
Government in reducing trade barriers and providing greater thrust to exports makes it
imperative for Accredited Laboratories to be at international level of competence.
194

Benefits of Accreditation:
 Potential increase in business due to enhanced
customer confidence and satisfaction.
 Savings in terms of time and money due to
reduction or elimination of the need for re-testing .
 Better control of laboratory operations and
feedback to laboratories as to whether they have
sound Quality Assurance System and are
technically competent.
195

 Increase of confidence in Testing / Calibration
data and personnel performing work.
 Customers can search and identify the
laboratories accredited by NABL for their specific
requirements from the directory of Accredited
Laboratories.
 Users of accredited laboratories will enjoy greater
access for their products, in both domestic and
international markets, when tested by accredited
laboratories.
196

Types of Laboratory can seek
Accreditation:
 Laboratories undertaking any sort of testing or
calibration in the specified fields.
 Private or government laboratories.
 Small operations to large multi-field laboratories.
 Site facilities, temporary field operations and
mobile laboratories.
197

TESTING
LABORATORIES
CALIBRATION
LABORATORIES
MEDICAL
LABORATORIES
 Biological
 Chemical
 Electrical
 Electronics
 Fluid-Flow
 Mechanical
 Non-Destructive
Testing
 Photometry
 Radiological
 Thermal
 Forensic
 Electro-Technical
 Mechanical
 Fluid Flow
 Thermal & Optical
 Radiological
 Clinical Biochemistry
 Clinical Pathology
 Haematology &
Immunohaematology
 Microbiology & Serology
 Histopathology
 Cytopathology
 Genetics
 Nuclear Medicine (in-
vitro tests only)
PROFICIENCY TESTING PROVIDERS
REFERENCE
MATERIAL
PRODUCERS
 Testing
 Calibration
 Medical
 Inspection
 Chemical Composition
 Biological & Clinical
Properties
 Physical Properties
 Engineering Properties
 Miscellaneous Properties
198

10 Step Approach To
Accreditation
 Awareness Training
 Quality Policy & Objectives Finalization
 Gap Analysis
 Documentation / Process Design
 Documentation / Process Implementation
 Internal Audit
 Management Review Meeting
 Shadow Audit
 Corrective –Preventive Actions
 Final Certification Audit
199

Step 1:- Awareness Training
 Separate training sessions for top
management, middle management and
junior level management.
 Creates a motivating environment
throughout the organization for ISO 17025
implementation.
200

Step 2:-Quality Policy &
Objectives
 Work shop with top management on
development of quality policy.
 Work shop with top management and
middle level functional management on
development of quality objectives.
201

Step 3:-Gap Analysis
 Understanding of all the operations of the
organization.
 Development of process map for the
activities of the organization.
 Comparing existing operations with
requirements of ISO 17025:2005 standard.
202

Step 4:-Documentation /
Process Design
 Quality Manual
 Functional Procedures
 Work Instructions
 System Procedures
 Formats
203

Step 5:-Documentation /
Process Implementation
 Work–shop on process / document
implementation as per ISO 17025
requirements.
 Departmental / Individual assistance in
implementing the new processes /
documents.
204

Step 6:-Internal Audit
 Internal Audit Training & Examination
(Optional).
 Successful employees / we carry out
internal audit of the organization covering
all the departments and operations.
 Suggest corrective and preventive actions
for improvements in each of the audited
departments.
205

Step 7:-Management Review
Meeting
 Quality Policy & Objectives
 Results of internal audit
 Results of supplier evaluation
 Results of customer complaints
 Results of customer feedback etc.
206

Step 8:-Shadow Audit
 A replica of final certification audit.
 Finds degree of compliance with ISO
17025 standard.
 Gives an idea to the employees about the
conduct of the final certification audit.
207

Step 9:-Corrective –
Preventive Actions
 On the basis of shadow audit conducted in
the last step, all the non-conformities will
be assigned corrective and preventive
actions.
 A check will ensure that all the NCs are
closed and the organization is ready for the
final certification audit.
208

Step 10:-Final Certification
Audit
 Upon completion of various stages of
accreditation audit, the audit, your
organization will be awarded accreditation.
209

5. NABL Certification Differ from ISO 9000
Certification:
ISO 9000 Certification is on Quality System Management only whereas the
NABL Accreditation provides formal recognition of technical competence of the
laboratories, thus providing a ready means for customers to find reliable testing
and calibration services in order to meet their demands as well as the Quality
system. Accreditation is a higher level activity than system certification.
Laboratories can be checked and certified for their compliance to international
management system standards such as ISO 9000. This involves the auditing of
an organization’s quality management system. Although this will give you
confidence of the laboratory’s quality system, it tells you nothing about its
technical competence or its ability to provide reliable and accurate test data that
will be accepted by your customers and trading partners.
211

Proper technical evaluation requires the use of technical experts
who can assess the laboratory against internationally accepted
criteria. These criteria are embraced globally in a document called
ISO/IEC 17025. Accreditation bodies may also apply additional
technical requirements for evaluating a laboratory, as per
requirements of different technical fields
6. Proficiency Testing Programmes Organized by
NABL:
All NABL accredited testing and calibration laboratories are required to participate in
Proficiency Testing Programmes conducted by NABL or the nodal organizations
appointed by NABL. Accredited and applicant laboratories are required to approach
NABL Co-coordinator for Proficiency Testing programs or the nodal laboratories
appointed by NABL whenever a PT programme for a specific testing / calibration is
organized by NABL. For calibration laboratories, NPL, Delhi is the main nodal laboratory.212

Laboratories are also expected to participate (as far as available and practicable) in
international Inter- Laboratory Comparison
/ Proficiency Programmes conducted by APLAC, EA or equivalent organizations. NABL
keeps the accredited laboratories informed about all such international programmes
through NABL newsletter / APLAC newsletter.
It is essential for all its accredited laboratories to participate in International / Regional
Proficiency Testing Programmes including APLAC in a manner so that all major areas
of scope of accreditation are covered in a cycle of 4 years. This of course applies to
those special areas where Inter-Laboratory Proficiency Testing Programmes are not
available.
All applicant laboratories are required to successfully participate in at least one Inter -
Laboratory Proficiency Testing in accordance with ISO/IEC Guide-43. For this purpose
all alternative techniques covered in ISO/IEC Guide-43 will be acceptable.
213

7.Criteria for using NABL Symbol:
All NABL accredited laboratories are expected to use NABL symbol on their
letterhead, test / calibration reports and any other relevant documents. NABL
symbol shall be used for the purpose of identifying correctly and unambiguously the
test / calibration services accredited by NABL.
While using the symbol it shall be ensured by the laboratory that design and its
manifestations are not distorted, it can be reproduced in any single color (preferably
black) and any size.
It shall be responsibility of the accredited laboratory that the use of symbol does not
misrepresent the scope of accredited testing / calibration services. In case where
the accreditation sought and granted do not cover all the
activities of the laboratory's services care should be exercised to restrict the use of
symbol only to those accredited activities. The letterheads and publicity materials,
brochures, test / calibration reports of the accredited laboratory bearing the NABL
symbol shall cover only the test results under accredited category.
214

 Accredited laboratories shall not authorize the use of symbol for
tests / calibration services sub-contracted to other laboratories,
which are not accredited by NABL.
 In case of complaints in this regard from users and other
laboratories, NABL shall get the same examined by a committee
and take appropriate action.
215

8. International Recognition of NABL:
NABL maintains its linkages with the international bodies like International
Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Laboratory
Accreditation Co-operation (APLAC). NABL is a full member of both ILAC and
APLAC.
NABL is a signatory to ILAC as well as APLAC Mutual Recognition Arrangements
(MRA), which is based on mutual evaluation and acceptance of other MRA
Partner laboratory accreditation systems. Such international arrangements
facilitate acceptance of test / calibration results between countries to which MRA
partners represent.
In order to achieve the objective of the acceptance of test / calibration data across
the national borders, NABL operates and is committed to update its laboratory
accreditation system as per international norms. A current NABL criterion for
Laboratory Accreditation is ISO/IEC 17025 standard for testing and calibration
laboratories and ISO 15189:2003 for medical laboratories. 216

 8.1 Asia Pacific Laboratory Accreditation Cooperation
(APLAC):
 It is the group of accreditation bodies in the Asia Pacific region
responsible for accrediting calibration, testing and inspection
facilities.
 This reduces the need for re-testing of products and therefore
saves time and money. APLAC has active programmed for the
development of technical guidance documents, inter-laboratory
comparisons (proficiency testing), and for training of laboratory
assessors.
 APLAC is recognized by Asia Pacific Economic Cooperation
(APEC) member economies as a Specialist Regional Body (SRB).
217

8.2 ISO/IEC 17025:
ISO/IEC 17025 is the basis for competency
of testing and calibration laboratories.
Accreditation to ISO/IEC 17025 requires
that:
 The laboratory has a quality system meeting requirements of
ISO 9001.
 The lab facility has adequate equipment to perform its
testing or calibration tasks.
 The lab facility has adequate laboratory personnel with the
competence to perform the calibration and testing.
 In addition most accreditation schemes in the U.S. require
proficiency testing amongst the laboratories.
Therefore, ISO/IEC 17025 is recognition of laboratory
competence, while ISO 9001 alone is simply recognition of
conformance to a quality system.
218

 8.3 International Laboratory Accreditation
Cooperation (ILAC):
 ILAC first started as a conference in 1977 with
the aim of developing international cooperation for
facilitating trade by promotion of the acceptance of
accredited test and calibration results.
 In 1996, ILAC became a formal cooperation with
a character to establish a network of mutual
recognition agreements among accreditation
bodies that would fulfill this aim.
219

Electronic Records; Electronic
Signatures (21 CFR Part 11).
221

21 CFR Part 11
 Part 11 applies to records in electronic form
that are created, modified, maintained,
archived, retrieved, or transmitted under
any records requirements set forth in
Agency regulations.
 Part 11 also applies to electronic records
submitted to the Agency under the Federal
Food, Drug, and Cosmetic Act (the Act)
and the Public Health Service Act (the PHS
Act), even if such records are not
specifically identified in Agency regulations.
222

 FDA's guidance documents, including this guidance,
do not establish legally enforceable responsibilities.
 In March of 1997, FDA issued final part 11
regulations that provide criteria for acceptance by
FDA, under certain circumstances, of electronic
records, electronic signatures, and handwritten
signatures executed to electronic records as
equivalent to paper records and handwritten
signatures executed on paper.
 After part 11 became effective in August 1997,
significant discussions ensued among industry,
contractors, and the Agency concerning the
interpretation and implementation of the regulations.
223

 21 CFR Part 11; Electronic Records; Electronic
Signatures, Validation
Signatures, Glossary of Terms
Signatures, Time Stamps
Signatures, Maintenance of Electronic Records
Signatures, Electronic Copies of Electronic Records
224

 Controls and Requirements
 limiting system access to authorized individuals
 use of operational system checks
 use of authority checks
 use of device checks
 determination that persons who develop, maintain, or use
electronic systems have the
 education, training, and experience to perform their
assigned tasks
 establishment of and adherence to written policies that
hold individuals accountable for
 actions initiated under their electronic signatures
 appropriate controls over systems documentation
 controls for open systems corresponding to controls for
closed systems bulleted above
 requirements related to electronic signatures
225

 Approaches of Part 11
 Narrow Interpretation of Scope
Under the narrow interpretation of the scope of part 11,
with respect to records required to be maintained under
predicate rules or submitted to FDA, when persons
choose to use records in electronic format in place of
paper format, part 11 would apply.
when persons use computers to generate paper
printouts of electronic records, and those paper records
meet all the requirements of the applicable predicate
rules and persons rely on the paper records to perform
their regulated activities, FDA would generally not
consider persons to be "using electronic records in lieu
of paper records"
226

 Definition of Part 11 Records
 Records that are required to be maintained under
predicate rule requirements and that are
maintained in electronic format in place of paper
format
 Electronic signatures that are intended to be the
equivalent of handwritten signatures, initials, and
other general signings required by predicate rules.
Part 11 signatures include electronic signatures
that are used, for example, to document the fact
that certain events or actions occurred in
accordance with the predicate rule (e.g. approved,
reviewed, and verified).
227

Validation
 Decision to validate computerized systems, and
the extent of the validation, take into account the
impact the systems have on your ability to meet
predicate rule requirements. You should also
consider the impact those systems might have on
the accuracy, reliability, integrity, availability, and
authenticity of required records and signatures.
Even if there is no predicate rule requirement to
validate a system, in some instances it may still be
important to validate the system.
228

Audit Trail
 The Agency intends to exercise enforcement
discretion regarding specific part 11 requirements
related to computer-generated, time-stamped audit
trails.
 Persons must still comply with all applicable
predicate rule requirements related to documentation
of, for example, date, time, or sequencing of events,
as well as any requirements for ensuring that changes
to records do not obscure previous entries.
 Audit trails can be particularly appropriate when users
are expected to create, modify, or delete regulated
records during normal operation.
229

 Legacy Systems
 This means that the Agency does not intend to take
enforcement action to enforce compliance with any
part 11 requirements if all the following criteria are
met for a specific system:
 The system was operational before the effective date.
 The system met all applicable predicate rule
requirements before the effective date.
 The system currently meets all applicable predicate
rule requirements.
 You have documented evidence and justification that
the system is fit for its intended use
(including having an acceptable level of record security
and integrity, if applicable).
230

Copies of Records
I. Producing copies of records held in common portable
formats when records are maintained in these formats
II. Using established automated conversion or export
methods, where available, to make copies in a more
common format (examples of such formats include, but
are not limited to PDF, XML, or SGML)
 the copying process used produces copies that preserve
the content and meaning of the record. If you have the
ability to search, sort, or trend part 11 records, copies
given to the Agency should provide the same capability if
it is reasonable and technically feasible. You should allow
inspection, review, and copying of records in a human
readable form at your site using your hardware and
following your established procedures and techniques for
accessing records.
231

Record Retention
 The Agency intends to exercise enforcement
discretion with regard to the part 11 requirements for
the protection of records to enable their accurate and
ready retrieval throughout the records retention
period.
 Persons must still comply with all applicable
predicate rule requirements for record retention and
availability
 In addition, paper and electronic record and signature
components can co-exist (i.e., a hybrid situation) as
long as predicate rule requirements are met and the
content and meaning of those records are preserved232

Reference
 http://www.nabl-india.org.
 http://www.fda.org.
 http://www.ilac.org/arrangement.htm.
 http://www.aplac.org/members/signatories_mra.htm.
 Food and Drug Administration References
1. Glossary of Computerized System and Software Development Terminology (Division of
Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA
1995) (http://www. fda.gov/ora/inspect_ref/igs/gloss.html)
2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff
(FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and
Research, 2002) (http://www.fda.gov/cdrh/comp/guidance/938.html)
3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use
in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
(http://www.fda.gov/cdrh/ode/guidance/585.html)
4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and
Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality
Systems Approach (FDA 2002) (http://www.fda.gov/oc/guidance/gmp.html)
233

 U.S. Department of Health and Human
Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research
(CBER)
Center for Devices and Radiological Health
(CDRH)
Center for Food Safety and Applied Nutrition
(CFSAN)
Center for Veterinary Medicine (CVM)
Office of Regulatory Affairs (ORA)
August 2003
Pharmaceutical CGMPs
234

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