INDUSTRIAL PHARMACY

1. QUALITY MANAGEMENT
SYSTEM
Presented by
(Dr.) Kahnu Charan Panigrahi
Asst. Professor (PHARMACEUTICS)

2. CONTENTS
•Concept of Quality
•Total Quality Management (TQM)
•Quality by Design (QbD)
•Six Sigma concept
•Out of Specification
•Change Control
•ISO 900 Series of Quality System Standard
•NABL
•GLP

3. Concept of Quality

4. BASIC CONCEPT OF QUALITY
• Quality is Customer Satisfaction
•Fitness for Use
•Degree of Excellence
•Different people use different parameters to define quality,
like; Beauty, Freshness, Expensiveness, Goodness, etc.
•Quality is the totality of features and characteristics of a
product or service that bear on its ability to satisfy given
needs.
•According to American Society for Quality, “Quality, an
inherent or distinguishing characteristic, a degree or grade
of excellence.”

6. •Goods and/or services and how they are produced involve many
types of processes, procedures, equipment, personnel, and
investments, which all fall under the quality umbrella.
•Key aspects of quality and how it's diffused throughout the business
are rooted in the concept of quality management.
1. Quality planning: It is implemented as a means of "developing the
products, systems, and processes needed to meet or exceed customer
expectations. This includes defining who the customers are,
determining their needs, and developing the tools (systems,
processes, etc.) needed to meet those needs.
2. Quality assurance: Iti s implemented as a means of providing
enough confidence that business requirements and goals (as outlined
in quality planning) for a product and/or service will be fulfilled. This
error prevention is done through systematic measurement,
comparison with a standard, and monitoring of processes.

7. 3.Quality control (QC): It is implemented as a means of fulfilling
quality requirements, reviewing all factors involved in production.
The business confirms that the good or service produced meets
organizational goals, often using tools such as operational
auditing and inspection. QC is focused on process output.
4.Quality improvement: It is implemented as a means of
providing mechanisms for the evaluation and improvement of
processes, etc. in the light of their efficiency, effectiveness, and
flexibility. This may be done with noticeably significant changes
or incrementally via continual improvement.

8. Total Quality Management (TQM)

9. Definition of Total Quality Management (TQM)
•Definition of total quality management (TQM) describes a
management approach to long–term success through customer
satisfaction.
•In a TQM effort, all members of an organization participate in
improving processes, products, services and the culture in which
they work.
•Total quality management (TQM) is the continual process of
detecting and reducing or eliminating errors in manufacturing,
streamlining supply chain management, improving the customer
experience, and ensuring that employees are up to speed with
training.

10. •Total quality management (TQM) is an ongoing process of
detecting and reducing or eliminating errors.
•It is used to streamline supply chain management, improve
customer service, and ensure that employees are trained.
•The focus is to improve the quality of an organization's outputs,
including goods and services, through the continual improvement
of internal practices.
•Total quality management aims to hold all parties involved in the
production process accountable for the overall quality of the final
product or service.

11. Principles of TQM:
Management Commitment
1. Plan (drive, direct)
2. Do (deploy, support, participate)
3. Check (review)
4. Act (recognize, communicate, revise)
Employee Empowerment
1. Training
2. Suggestion scheme
3. Measurement and recognition
4. Excellence teams
Fact Based Decision Making
1. SPC (statistical process control)
2. DOE, FMEA
3. The 7 statistical tools
4. TOPS (Ford 8D – team-oriented
problem solving)
Continuous Improvement
1. Systematic measurement
2. Excellence teams
3. Cross-functional process management
4. Attain, maintain, improve standards
Customer Focus
1. Supplier partnership
2. Service relationship with internal customers
3. Never compromise quality
4. Customer driven standards

12. Here are the 8 principles of total quality management:
1.Customer-focused: The customer ultimately determines
the level of quality. Quality improvement—training employees,
integrating quality into the design process, or upgrading
computers or software.
2.Total employee involvement: All employees participate in
working toward common goals. Total employee commitment
can only be obtained after fear has been driven from the
workplace, when empowerment has occurred, and when
management has provided the proper environment. Self-
managed work teams are one form of empowerment.
Primary Elements of Total Quality Management (TQM)

13. 3.Process-centered: A fundamental part of TQM is a focus on
process thinking. A process is a series of steps that take inputs from
suppliers (internal or external) and transforms them into outputs
that are delivered to customers (internal or external). The steps
required to carry out the process are defined, and performance
measures are continuously monitored in order to detect
unexpected variation.
4.Integrated system: Although an organization may consist of many
different functional specialties often organized into vertically
structured departments, it is the horizontal processes
interconnecting these functions that are the focus of TQM.

14. 5.Strategic and systematic approach: A critical part of the management of quality
is the strategic and systematic approach to achieving an organization’s vision,
mission, and goals. This process, called strategic planning or strategic management,
includes the formulation of a strategic plan that integrates quality as a core
component.
6.Continual improvement: A large aspect of TQM is continual process
improvement. Continual improvement drives an organization to be both analytical
and creative in finding ways to become more competitive and more effective at
meeting stakeholder expectations.
7.Fact-based decision making: In order to know how well an organization is
performing, data on performance measures are necessary. TQM requires that an
organization continually collect and analyze data in order to improve decision making
accuracy, achieve consensus, and allow prediction based on past history.
8.Communications: During times of organizational change, as well as part of day-
to-day operation, effective communications plays a large part in maintaining morale
and in motivating employees at all levels.

15. Benefits of TQM:
TQM has numerous benefits. It enables organizations to:
a) attain higher profitability and increased market share
b) improve customer satisfaction
c) improve organizational productivity
d) improve employee morale and job satisfaction
e) create a positive work culture
f) undertake systematic problem solving and decision making
through project teams
g) improve teamwork
h) create a climate conducive to continuous improvement

18. Example: Imprints of TQM concepts can be found in modern
approaches to quality management, such as the Malcolm Baldrige
National Quality Award (MBNQA) criteria, ISO 9001, Six
Sigma and lean manufacturing etc.

19. STRATEGY MODEL FOR IMPLEMENTING TQM SYSTEMS
Strategy 1: The TQM element approach
The TQM element approach takes key business processes and/or
organizational units and uses the tools of TQM to foster
improvements. This method was widely used in the early 1980s as
companies tried to implement parts of TQM as they learned them.
Examples of this approach include quality circles, statistical process
control, Taguchi methods, and quality function deployment.
Strategy 2: The guru approach
The guru approach uses the teachings and writings of one or more
of the leading quality thinkers as a guide against which to determine
where the organization has deficiencies. The organization makes
appropriate changes to remedy those deficiencies. For example,
managers might study Deming’s 14 points or attend the Crosby
College. Afterward, they would work on implementing the approach
learned.

20. Strategy 3: The organization model approach
In this approach, individuals or teams visit organizations that have taken a
leadership role in TQM and determine their processes and reasons for success.
They then integrate these ideas with their own ideas to develop an organizational
model adapted for their specific organization. This method was used widely in the
late 1980s and is exemplified by the initial recipients of the Malcolm Baldrige
National Quality Award.
Strategy 4: The Japanese total quality approach
Organizations using the Japanese total quality approach examine the detailed
implementation techniques and strategies employed by Deming Prize-winning
companies and use this experience to develop a long-range master plan for in-
house use. This approach was used by Florida Power and Light—among others—to
implement TQM and to compete for, and win, the Deming Prize.
Strategy 5: The award criteria approach
When using this model, an organization uses the criteria of a quality award (e.g.,
the Deming Prize, the European Quality Award, or the Malcolm Baldrige National
Quality Award), to identify areas for improvement. Under this approach, TQM
implementation focuses on meeting specific award criteria. Although some argue
that this is not an appropriate use of award criteria, some organizations do use this
approach and it can result in improvement.

21. Quality by Design (QbD)

22. Quality by Design (QbD)
is a concept first outlined by well-known quality expert Joseph M.
Juran.
RIPS 22
“Quality can be planned and most quality crises and problems relate
to the way in which quality was planned in the first place.”
Juran on Quality by Design (1992)
Quality- by-design (QbD) is a concept introduced by the International Conference
on Harmonization (ICH) Q8 guideline, as a systematic approach to development,
which begins with predefined objectives and emphasizes product and process
understanding and process control, based on sound science and quality risk
management.

23. • Predefined objectives make up the quality target product profile
(QTPP), that is, the summary of the drug product quality
characteristics that ideally should be achieved.
• According to the ICH Q8 guideline, QTPP is a prospective summary
of the quality characteristics of a drug product to ensure the
desired quality, taking into account safety and efficacy of that drug
product.
• Through the scientifically based process of product development,
critical process parameters (CPPs), and critical quality attributes
(CQAs) of the product are identified.
• CQA is a physical, chemical, biological, or microbiological property
or characteristic that should be within an appropriate limit, range,
or distribution to ensure the desired product quality.
23

24. • A QTPP for immediate release tablets may include
the following requirements: assay, content
uniformity, and dissolution should be in accordance
with the specifications to assure safety and efficacy
during the shelf life; tablets should be robust in order
to withstand transport and handling, and a suitable
size to aid patient acceptability and compliance.
• According to the defined QTPP, CQAs may include
assay, content uniformity, dissolution, and
degradation products, whereas CPPs could be the
compression force and speed used for tableting.
• Figure 1.1 shows a diagram of a QbD approach,
combining design space development and risk
management tools.
24

25. Elements of pharmaceutical quality by design
1. A quality target product profile (QTPP) that identifies the critical
quality attributes (CQAs) of the drug product
2. Product design and understanding including the identification of
critical material attributes (CMAs)
3. Process design and understanding including the identification of
critical process parameters (CPPs) and a thorough understanding of
scale-up principles, linking CMAs and CPPs to CQAs
4. A control strategy that includes specifications for the drug
substance(s), excipient(s), and drug product as well as controls for
each step of the manufacturing process
5. Process capability and continual improvement
RIPS 25

26. 26

27. SIX SIGMA CONCEPT

28. Overview
• σ Sigma is a statistical concept that represents the
amount of variation present in a process relative to
customer requirements or specifications.
• A statistical concept that measures a process in
terms of defects – at the six sigma level, there 3.4
defects per million opportunities
• Commonly denoted as 6σ, 6 Sigma, or 6s
• Six Sigma is a set of techniques, and tools for process
improvement.
• It was developed by Motorola in 1986.
• Sir Bill Smith, “ the Father of six sigma” introduce
this quality improvement Methodology to Motorola.

29. •Six Sigma is now an enormous 'brand' in the world of corporate
development.
•Six Sigma seeks to improve the quality of process outputs by
identifying and removing the causes of defects.
•Six Sigma approach is a collection of managerial and statistical
concept and techniques that focuses on reducing variation in
processes and preventing deficiencies in product.
•The concept of variation states “No two items will be perfectly
identical.”
•A six sigma process is one in which 99.9999966% of the products
manufactured are statistically expected to be free of defects (3.4
defects per million).
•Six Sigma is a very clever way of branding and packaging many
aspects of Total Quality Management (TQM).
•Manufacturing methods of six sigma are used in Batch production,
Job production & Mass production.

30. Six Sigma projects follow two project methodologies,
inspired by W. Edwards Deming's Plan–Do–Study–Act
Cycle, each with five phases.
•DMAIC: is used for projects aimed at improving an
existing business process
•DMADV: is used for projects aimed at creating new
product or process designs
Methodologies

31. The DMAIC project methodology has five
phases:
• Define the system, the voice of the
customer and their requirements, and the
project goals, specifically.
• Measure key aspects of the current process
and collect relevant data.
• Analyze the data to investigate and verify
cause and effect.

32. • Improve or optimize the current process
based upon data analysis using techniques
such as design of experiments, poka yokeor
mistake proofing, and standard work to create
a new, future state process. Set up pilot runs
to establish process capability.
• Control the future state process to ensure that
any deviations from the target are corrected
before they result in defects.
Implement control systems such as statistical
process control, production boards, visual
workplaces, and continuously monitor the
process.

33. Also known as DFSS ("Design For Six Sigma"), the DMADV
methodology's five phases are:
•Define design goals that are consistent with customer
demands and the enterprise strategy.
•Measure and identify CTQs (characteristics that
are Critical To Quality), measure product capabilities,
production process capability, and measure risks.
•Analyze to develop and design alternatives
•Design an improved alternative, best suited per analysis in
the previous step
•Verify the design, set up pilot runs, implement the
production process and hand it over to the process
owner(s).

35. Implementation
Six Sigma identifies several key roles for its successful
implementation:-
• Executive Leadership, includes the CEO and other members of
top management. They are responsible for setting up a vision
for Six Sigma implementation.
• Champions, take responsibility for Six Sigma implementation
across the organization in an integrated manner.
• Master Black Belts (MBB), identified by champions, act as in-
house coaches on Six Sigma. They devote 100% of their time to
Six Sigma. They assist champions and guide Black Belts and
Green Belts.
• Black Belts, operate under Master Black Belts to apply Six
Sigma methodology to specific projects.
• Green Belts, are the employees who take up Six Sigma
implementation along with their other job responsibilities,
operating under the guidance of Black Belts.

38. Software used for Six Sigma
• ARIS Six Sigma
• IBM WebSphere Business Modeler
• JMP
• Oracle Crystal Ball (part of Oracle Fusion
Middleware)
• Microsoft Visio
• Minitab
• NCSS Statistical Software
• QPR ProcessGuide by QPR Software
• Quality Companion by Minitab
• RCASE
• R language

39. Tools and methods
• Analysis of variance
• General linear model
• ANOVA Gauge R&R
• Regression analysis
• Correlation
• Scatter diagram
• Chi-squared test
• SIPOC analysis
(Suppliers, Inputs, Process, Outputs, Customers)
• COPIS analysis (Customer centric version/perspective of
SIPOC)
• Taguchi methods/Taguchi Loss Function
• Value stream mapping
• Control Chart

40. Out-of-Specification (OOS)
Test Results

41. •This guidance for industry provides the Agency’s current thinking
on how to evaluate out-of specification (OOS) test results.
•For purposes of this document, the term OOS results includes all
test results that fall outside the specifications or acceptance criteria
established in drug applications, drug master files (DMFs), official
compendia, or by the manufacturer. The term also applies to all in-
process laboratory tests that are outside of established
specifications.
•This guidance applies to chemistry-based laboratory testing of
drugs regulated by Center for Drug Evaluation and Research (CDER).
It is directed toward traditional drug testing and release methods.
•These laboratory tests are performed on active pharmaceutical
ingredients, excipients and other components, in-process materials,
and finished drug products3 to the extent that current good
manufacturing practice (CGMP) regulations (21 CFR parts 210 and
211) and the Federal Food, Drug, and Cosmetic Act (the Act)
(section 501(a)(2)(B)) apply.

42. IDENTIFYING AND ASSESSING OOS TEST RESULTS — PHASE I:
LABORATORY INVESTIGATION
•FDA regulations require that an investigation be conducted
whenever an OOS test result is obtained .
•The purpose of the investigation is to determine the cause of the
OOS result.
• The source of the OOS result should be identified either as an
aberration of the measurement process or an aberration of the
manufacturing process.
•The regulations require that a written record of the investigation be
made, including the conclusions and follow-up.
•The investigation should be thorough, timely, unbiased, well-
documented, and scientifically sound.
•The first phase of such an investigation should include an initial
assessment of the accuracy of the laboratory's data.

43. •Whenever possible, this should be done before test preparations
are discarded.
•This way, hypothesis regarding laboratory error or instrument
malfunctions can be tested using the same test preparations.
• If this initial assessment indicates that no meaningful errors were
made in the analytical method used to arrive at the data, a full-
scale OOS investigation should be conducted.
•For contract laboratories, the laboratory should convey its data,
findings, and supporting documentation to the manufacturing
firm’s quality control unit (QCU), who should then initiate the full-
scale OOS investigation.

44. INVESTIGATING OOS TEST RESULTS —
PHASE II: FULL-SCALE OOS
INVESTIGATION
•When the initial assessment does not determine that laboratory
error caused the OOS result and testing results appear to be
accurate, a full-scale OOS investigation using a predefined
procedure should be conducted.
•This investigation may consist of a production process review
and/or additional laboratory work. The objective of such an
investigation should be to identify the root cause of the OOS
result and take appropriate corrective and preventative action.
•A full-scale investigation should include a review of production
and sampling procedures, and will often include additional
laboratory testing.
•Such investigations should be given the highest priority. Among
the elements of this phase is evaluation of the impact of OOS
result(s) on already distributed batches.

45. CONCLUDING THE INVESTIGATION
•To conclude the investigation, the results should be evaluated, the
batch quality should be determined, and a release decision should
be made by the QCU.
•The SOPs should be followed in arriving at this point.
•Once a batch has been rejected, there is no limit to further testing
to determine the cause of the failure so that a corrective action can
be taken.

46. Change Control

47. •Change control within quality management systems (QMS)
and information technology (IT) systems is a process—either formal
or informal—used to ensure that changes to a product or system
are introduced in a controlled and coordinated manner.
•It reduces the possibility that unnecessary changes will be
introduced to a system without forethought, introducing faults into
the system or undoing changes made by other users of software.
•The goals of a change control procedure usually include minimal
disruption to services, reduction in back-out activities, and cost-
effective utilization of resources involved in implementing change.
•Change control is used in various industries, including in
IT, software development, the pharmaceutical industry, the medical
device industry, and other manufacturing industries.

48. Change control can be described as a set of
six steps:
1. Plan / Scope
2. Assess / Analyze
3. Review / Approval
4. Build / Test
5. Implement
6. Close

49. Plan / Scope
Consider the primary and ancillary details of the proposed change.
Should include aspects such as identifying the change, its owner(s),
how it will be communicated and executed, how success will be
verified, the change's estimate of importance, its added value, its
conformity to business and industry standards, and its target date for
completion.
Assess / Analyze
Impact and risk assessment is the next vital step. When executed, will
the proposed plan cause something to go wrong? Will related
systems be impacted by the proposed change? Even minor details
should be considered during this phase. Afterwards, a risk category
should ideally be assigned to the proposed change: high-, moderate-,
or low-risk. High-risk change requires many additional steps such as
management approval and stakeholder notification, whereas low-risk
change may only require project manager approval and minimal
documentation.

50. Review / Approval
Whether it's a change controller, change control board, steering
committee, or project manager, a review and approval process is
typically required. The plan/scope and impact/risk assessments are
considered in the context of business goals, requirements, and
resources. If, for example, the change request is deemed to address a
low severity, low impact issue that requires significant resources to
correct, the request may be made low priority or shelved altogether.
Build / Test
If the change control request is approved to move forward, the
delivery team will execute the solution through a small-scale
development process in test or development environments. This
allows the delivery team an opportunity to design and make
incremental changes, with unit and/or regression testing.Little in the
way of testing and validation may occur for low-risk changes, though
major changes will require significant testing before implementation.
In rare cases where the solution can't be tested, special consideration
should be made towards the change/implementation window.

51. Implement
In most cases a special implementation team with the technical
expertise to quickly move a change along is used to implement the
change. The team should also be implementing the change not only
according to the approved plan but also according to organizational
standards, industry standards, and quality management
standards. The implementation process may also require additional
staff responsibilities outside the implementation team, including
stakeholders who may be asked to assist with trouble shooting.
Close
The closing process can be one of the more difficult and important
phases of change control. Three primary tasks at this end phase
include determining that the project is actually complete, evaluating
"the project plan in the context of project completion," and providing
tangible proof of project success. If despite best efforts something
went wrong during the change control process, a post-mortem on
what happened will need to be run, with the intent of applying lessons
learned to future changes.

52. Introduction of IS/ISO 9000
•Quality becomes a major focus of businesses throughout the
world and various organizations developed standards and
guidelines such as quality management, quality control, quality
assurance and quality system.
what is standard?
Standards are documented agreements containing technical
specifications or other precise criteria to be used consistently as to
ensure that rules, guidelines, materials, products, processes and
services are fit for their purpose.

53. ISO [International organization for standardization] is a non-
governmental organization established in 1946 in Geneva,
Switzerland.
It defines quality system standards
To meet five objectives
1. Achieve, maintain and seek to continuously improve
product quality [including services] in relationship to
requirements
2. Improve the quality of operations
3. Provide confidence to internal management
4. Provide confidence to customers
5. Provide confidence that quality system requirements are
fulfilled

54. STRUCTURE OF ISO 9000 STANDARDS
The ISO 9000:2000 standards focus on developing,
documenting and implementing procedures
– to ensure consistently of operations
– and performance in production and service delivery
processes, with the aim of continual improvement and
also supported by fundamental principles of total quality
• It is a series of standards that are "generic rather than
specific"
• It can be applied to all type of organizations, large or
small scale industry, public, private,...
• ISO standards are developed through consensus, applied
industry wide and it is voluntary

55. The standard consists of 3 documents
• ISO 9000 (Fundamentals & Vocabulary)
• ISO 9001 (Quality Management Systems – set of 4 minimum
Requirements)
– Management Responsibility
– Resource Management
– Product Realization
– Measurement analysis & improvement
• ISO 9004: 2000
-Quality Management Systems – Guidelines for performance
improvements
-Relates to organizations who wish to improve beyond the scope of
ISO 9001
-Has an element of self evaluation and this standard does not stand
for certification

56. CONTENTS OF ISO 9001:2000 STANDARD
1. Management responsibilities
• Management commitment
• Customer focus
• Quality policy
• Planning
• Responsibility, authority and communication
• Management review
2.Resource management
• People
• Infrastructure
• Work environment
• Information
• Suppliers
• Natural resources
• Financial resources

57. 3. Product realization
– Planning of product
– Processes of interested parties (customer)
– Design and development
• Design and development planning
• Inputs
• Outputs
• Review
• Verification
• Validation
• Control
– Purchasing process
– Production and Service provision
– Control of measuring and monitoring facilities

58. 4. Measurement, analysis and improvement
– General instructions
– Monitoring and Measurement
• Customer satisfaction
• Internal audit
• Process
• Product and service
– Control of non-conforming product
– Analysis of data
– Improvement
• Continuous improvement
• Corrective action
• Preventive action

60. In ISO 9001:1994 series consists of 20 fundamental
elements of basic quality system that includes:
– Management responsibility
– Quality system
– Contract review
– Design control
– Document and data control
– Purchasing
– Customer supplied product
– Product identification and traceability
– Process control
– Inspection and testing
– Inspection, measuring and test equipment
– Inspection and test status
– Control of nonconforming product
– Corrective and preventive action
– Handling storage, packaging
preservation and delivery
– Quality records
– Internal quality audits
– Training
– Servicing
– Statistical techniques

61. ISO 9000:2000
Quality management principles
1. Customer focus
– Needs and requirements
2. Leadership
– Direction of the organization, unity of purpose
3. Involvement of people
– Human resource focus
4. Process approach
– activities and related resources are managed as a process
5. System approach to management
– Managing interrelated process as system leading to efficiency of the
organization
6. Continual improvement
7. Factual approach to decision making
– Decision making is based on the analysis of data and information
8. Mutually beneficial supplier relationships
– Organization and suppliers are interdependent and mutually beneficial
relationship enhances the ability of both to create value

62. All ISO standards are reviewed every five years to establish if a
revision is required to keep it current and relevant for the
marketplace
• ISO 9001:2015 is designed to respond to the latest trends and be
compatible with other management systems such as ISO 14001
• The new version follows a new, higher level structure to make it
easier to use in conjunction with other management system
standards, with increased importance given to risk Enhanced
product quality and reliability at a reasonable price
• Improved health, safety and environmental protection, and
reduction of waste
• Greater compatibility and interoperability of goods and services
• Simplification for improved usability
• Reduction in the number of models, and thus reduction in costs
• Increased distribution efficiency, and ease of maintenance
ISO 9001 has been updated

63. National Accreditation Board for Testing and
Calibration Laboratories (NABL)
•NABL is a constituent board of Quality Council of India which is an
autonomous body setup under Department for Promotion of
Industry and Internal Trade (DPIIT), Ministry of Commerce and
Industry, Government of India.
•National Accreditation Board for Testing and Calibration
Laboratories (NABL) provides accreditation to Conformity
Assessment Bodies (Laboratories) in India.
•NABL Schemes include Accreditation (Recognition) of Technical
competence of testing, calibration, medical testing laboratories,
Proficiency testing providers (PTP) & Reference Material Producers
(RMP) for a specific scope following ISO/IEC 17025, ISO
15189, ISO/IEC 17043 & ISO 17034:2016 Standards.
• It has Mutual Recognition Arrangement (MRA) with Asia Pacific
Laboratory Accreditation Cooperation (APLAC), International
Laboratory Accreditation Cooperation (ILAC).

64. •NABL provides accreditation in all major fields of Science and
Engineering such as Biological, Chemical, Electrical, Electronics,
Mechanical, Fluid-Flow, Non-Destructive, Photometry, Radiological,
Thermal & Forensics disciplines under testing facilities and Electro-
Technical, Mechanical, Fluid Flow, Thermal, Optical & Radiological
disciplines under Calibration facilities.
•In the field of Medical Testing laboratories accreditation is granted in
Clinical Biochemistry, Clinical Pathology, Haematology & Immuno-
haematology, Microbiology & Serology, Histopathology,
cytopathology, Genetics, Nuclear Medicine (In-vitro tests only)
disciplines.
•In addition, NABL offers accreditation for Proficiency testing
providers & Reference Material producers for which it has APLAC
MRA.
•NABL being a governmental body conducts integrated assessments
with regulators such as FSSAI, EIC, APEDA, etc. Integrated assessments
simplify the process of recognition.

65. Good Laboratory Practice
•In the experimental (non-clinical) research arena, good
laboratory practice or GLP is a quality system of
management controls for research laboratories and
organizations to ensure the uniformity,
consistency, reliability, reproducibility, quality, and
integrity of products in development for human or animal
health (including pharmaceuticals) through non-clinical
safety tests; from physio-chemical properties through
acute to chronic toxicity tests.
•GLP was first introduced in New Zealand and Denmark in
1972, and later in the US in 1978 in response to
the Industrial BioTest Labs scandal.

66. •It was followed a few years later by the Organization for Economic
Co-operation and Development (OECD) Principles of GLP in 1992;
the OECD has since helped promulgate GLP to many countries.
•GLP applies to non-clinical studies conducted for the assessment of
the safety or efficacy of products in development (including
pharmaceuticals) for people, animals, and the environment.
•GLP, a data and operational quality system, is not the same as
standards for laboratory safety - appropriate gloves, glasses and
clothing to handle lab materials safely.
•The principles of GLP aim to ensure and promote safety,
consistency, high quality, and reliability of chemicals in the process
of non-clinical and laboratory testing.
•GLP is not limited to chemicals and also applies to medical
devices, food additives, food packaging, colour additives, animal
food additives, other non-pharmaceutical products or ingredients,
biological products, and electronic products.

67. 1. Organization and Personnel
Management-Responsibilities
Sponsor-Responsibilities
Study Director-Responsibilities
Principal Investigator-Responsibilities
Study Personnel-Responsibilities
2. Quality assurance program
Quality Assurance Personnel
3. Facilities
Test System Facilities
Facilities for Test and Reference Items
4. Equipment, reagents and materials
5. Test system
Physical/Chemical
Biological
6. Test and reference items
7. Standard operating procedures
8. Performance of study
Study Plan
Conduct of Study
9. Reporting of results
10. Archival - Storage of Records and
Reports
GLP is a quality system concerned with the organizational process
and conditions under which non-clinical health and environmental
safety studies are planned, performed, monitored, recorded,
archived and reported.
GLP principles include

68. Thank You