Concepts of GLP and ISO 9000. The Good Laboratory Practices Guideline (GLP) is an FDA regulation. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded and reported. National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA). NGCMA was established by the Department of Science & Technology (DST), Government of India, with the approval of the Union Cabinet on April 24, 2002. ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), which is an independent, non-governmental organization made up of members from over 160 countries. The ISO 9000 family of standards is related to Quality Management Systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements. ISO 9000 deals with the fundamentals of quality management systems, including the 7 Quality Management Principles on which the family of standards is based.

1. CONCEPTS OF
GLP & ISO 9000
Presented by:
Miss Shruti Ashok Salve
1st Year M.Pharmacy
Dept. of Pharmacognosy
Submitted to:
Miss B. R. Gupta
Dept. of
Pharmacognosy
Department of Pharmacognosy
MGV’s Pharmacy College, Panchavati, Nashik

2. List of content
1. Concepts of Good Laboratory Practices (GLP)
2. GLP Principles
3. General Rules of GLP
4. Concepts of ISO 9000
5. Quality Management System
6. ISO 9000 Certification
7. Benefits of ISO 9001:2015
8. References

3. Review of Literature
Alatgi AC, Chougule SB., “Good laboratory practice”, Journal of
Evolution of Medical and Dental Sciences 2015; Vol. 4, Issue 103,
December 24
In the present era of rapidly evolving technology and evidence
based medicine, Good Laboratory Practice (GLP) shall play an
important role in ensuring, consistency, reliability, reproducibility
and quality of laboratory tests. It provides a frame work for
laboratories to plan, perform, monitor, record and report their
activities. It also reflects the quality of laboratory services during
any assessments and accreditation process.

4. Review of Literature
Sanjiv Kumar Jain and Inderpreet Singh Ahuja, ISO 9000
Quality Management System: Literature review, International
Journal of Technology, Policy and Management, Vol. 12, No. 4
ISO 9000 is a management system that outlines the
minimum requirements for organizations to follow for Quality
Management Systems (QMS) and, hence, helps to ensure that a
company provides a consistent quality product or service. The
purpose of this paper is to review the literature on the ISO 9000
and to present an overview of ISO implementation practices
adopted by manufacturing organizations.

5. Concepts Of Good Laboratory
Practices (GLP)
 The Good Laboratory Practices Guideline (GLP) is an FDA
regulation.
 Good Laboratory Practices (GLP) embodies a set of principles that
provides a framework within which laboratory studies are planned,
performed, monitored, recorded and reported.
 The Good Laboratory Practice Guidelines (GLP) has been in
existence for non-clinical safety studies since 1976.
 GLP helps assure regulatory authorities that the data submitted are
true reflection of the results obtained during the study.

6. Concepts Of Good Laboratory
Practices (GLP)
 GLP is a requirement in regulatory non-clinical safety testing of
the following test items:
1. Pharmaceutical products
2. Pesticide products
3. Cosmetic products
4. Veterinary products
5. Food additives
6. Industrial chemicals.

7. National Good Laboratory Practice (GLP) Compliance Monitoring
Authority (NGCMA)
 NGCMA was established by the Department of Science & Technology
(DST), Government of India, with the approval of the Union Cabinet on
April 24, 2002
 The National GLP Programme functions through an Apex Body,
represented by Secretaries of concerned Ministries.
 The Apex Body is supported by Technical Committee on GLP, which
is a recommending body of NGCMA on cases of GLP certification and
various technical matters concerning GLP.

8. Good Laboratory Practices Principles
1. Test Facility Organisation and Personnel.
2. Quality Assurance Programme (QAP).
3. Facilities
4. Apparatus, Material and Reagents
5. Test and Reference Substances
6. Standard Operating Procedures (SOP)
7. Performance of The Study
8. Reporting of Study Results
9. Storage and Retention of Records and materials.

9. 1. Test Facility Organization and
Personnel
Study Personnel Responsibilities
 Should have the Knowledge of the GLP principles.
 Access to the study plan and appropriate SOP's
 Comply with the instructions of the SOP's
 Record raw data.
 Study personnel are responsible for the quality of their data.
 Exercise health precautions to minimize risk
 Ensure the integrity of the study.

10. 2. Quality Assurance Program
Responsibilities of the QA Personnel
 Access to the updated study plans and SOP's.
 Documented verification (Analytical worksheet) of the compliance of
study plan to the GLP principles.
 Inspections to determine compliance of the study with GLP principles.
 Three types of inspections are Study, Facility and Process based
inspections
 Inspection of the final reports should accurate and in full description.
 Report the inspection results to the management.

11. 3. Facilities
 Suitable size, construction and location of laboratory.
 Adequate degree of separation of the different activities.
 Isolation of test systems and individual projects to protect from
biological hazards.
 Suitable rooms for the diagnosis, treatment and control of
diseases.
 Storage rooms.

12. 4. Apparatus, Materials and Reagents
 Apparatus of appropriate design and adequate capacity.
 Documented Inspection, cleaning, maintenance and calibration
of apparatus.
 Apparatus and materials not to interfere with the test systems.
 Chemicals, reagent and solutions should be labeled to indicate
identity, expiry and specific storage instructions.

13. Standard Operating Procedures
(SOP’s)
 Written procedures for a laboratories program.
 They define how to carry out protocol-specified activities.
 Most often written in a chronological listing of action steps.
 They are written to explain how the procedures are suppose to work.
 Routine inspection, cleaning, maintenance, testing and calibration.
 Actions to be taken in response to equipment failure.
 Keeping records, reporting, storage, mixing, and retrieval of data.
 Analytical methods.

14. General Rules
 Safety data sheets must be available to staff before testing is carried
out.
 Smoking, eating and drinking in the laboratory must be prohibited.
 Staff must be familiar with the use of fire-fighting equipment, i.e. fire
extinguishers, gas masks.
 Staff must wear laboratory coats or other protective clothing, including
eye protection.
 Special care must be taken in handling, e.g. highly potent, infectious or
volatile substances.

15. General Rules
 All containers of chemicals must be fully labelled and include
prominent warnings (e.g. "Poison", "Flammable", "Radiation", etc.)
whenever appropriate.
 Staff must be aware of the need to avoid working alone in the
laboratory.
 First-aid materials must be provided and staff instructed in first-aid
techniques, emergency care and the use of antidotes.
 Highly toxic and/or carcinogenic samples should be handled in a
specially designed facility to avoid the risk of contamination.

16. Concepts of ISO 9000
 ISO 9000 is a series of standards, developed and published by the
International Organization for Standardization (ISO), which is an
independent, non-governmental organization made up of members from
over 160 countries.
 The ISO 9000 family of standards is related to Quality Management
Systems and designed to help organizations ensure that they meet the
needs of customers and other stakeholders while meeting statutory and
regulatory requirements.
 ISO 9000 deals with the fundamentals of quality management systems,
including the 7 Quality Management Principles on which the family of
standards is based.

17. Concepts of ISO 9000
 International standards promote international trade by providing
one consistent set of requirements recognized around the world.
 ISO 9000 can help a company satisfy its customers, meet regulatory
requirements and achieve continual improvement.
 It provides the base level of a quality system, not a complete
guarantee of quality.
 It is originally published in 1987 by the International Organization
for Standardization (ISO)

18. Quality Management System
 A quality management system (QMS) defines and establishes an
organization's quality policy and objectives.
 A properly implemented QMS ensures that procedures are carried
out consistently, so that problems can be identified and resolved, and
the organization can continuously review and improve its procedures,
products and services.
 It is a mechanism for maintaining and improving the quality of
products or services so that they consistently meet or exceed the
customer's needs and fulfill their quality objectives.

20. The 7 Quality Management Principles
1. Customer focus - Quality management primarily focuses on meeting
customer requirements and striving to exceed customer expectations.
2. Leadership - Helping leaders to establish unity of purpose and
direction at all levels and to create conditions to engage members of
the organization in achieving the organization's quality objectives.
3. Engagement of people - Obtaining and maintaining (at all levels
throughout the organization) competent, empowered, and engaged
people to enhance the organization's capability to create and deliver
value

21. The 7 Quality Management Principles
4. Process approach - Delivering consistent and predictable results
through the use of effective and efficient activities that are understood
and managed as interrelated processes.
5. Improvement - Maintaining an ongoing, organization-wide focus on
improvement.
6. Evidence-based decision making - Using the analysis and evaluation of
data and information in the decision making process to produce
desired results.
7. Relationship management - Managing the organization's relationships
with related parties, such as partners or vendors, for sustained
success.

22. ISO 9000 Series
 ISO 9000 gives fundamental quality concepts and principles for
quality management system.
 ISO 9001 is defined as the International standard that specifies
requirements for a Quality Management System (QMS)
 ISO 9002 is a model for quality assurance in production and
installation.
 ISO 9003 for quality assurance in final inspection and test.
 ISO 9004 gives guidance on achieving sustained organizational success.

23. ISO 9001:2015
 ISO 9001 is the requirement standard of the ISO 9000 family of
standards.
 The latest version of ISO 9001 standard was introduced in the
month of September 2015
 Hence, it is referred to as ISO 9001:2015
 It outlines the guidelines that an organization must follow in
order to implement and maintain a Quality Management System.

24. How is the ISO 9001:2015
Standard Structured?
 ISO 9001:2015 Quality Management Systems Requirements is
a document of approximately 30 pages, which is available from
the national standards organization in each country.
 ISO 9001:2015 (the most recent version of the standard) is
made up of a different clauses, each concentrating on the
requirements involved in different aspects of a quality
management system.
 The requirements of the standards are specified in different
clauses. There are 8 clauses in ISO 9001:2015

25. Clauses
The requirements of the standards are specified in following
clauses of the standard:
 Clause 1-3 : Introduction and Scope of Standard
 Clause 4 : Quality Management System (QMS)
 Clause 5 : Management responsibility
 Clause 6 : Resource management
 Clause 7 : Product realization
 Clause 8 : Measurement, analysis and improvement

26. ISO 9000 Certification
 International Organization for Standardization (ISO) does not
certify organizations itself.
 Numerous certification bodies exist, which audit organizations and,
upon success, issue ISO 9001 compliance certificates.
 Although commonly referred to as ISO 9000 certification, the actual
standard to which an organization's quality management system can
be certified is ISO 9001:2015.
 Many countries have formed accreditation bodies to authorize the
certification bodies. In India, we have MSME.

27. ISO 9000 Certification
 An organization applying for ISO 9001 certification is audited based
on an extensive sample of its sites, functions, products, services and
processes.
 The auditor presents a list of problems (defined as non-conformities)
to management.
 If there are no major non-conformities, the certification body will
issue a certificate.
 An ISO 9001 certificate is not a once-and-for-all award, but must be
renewed at regular intervals recommended by the certification body,
usually once every 3 years.

28. Benefits of ISO 9001:2015
 Quality is maintained.
 ISO registration has significant bearing on market credibility as
well.
 Opportunity to compete with larger companies.
 More time spent on customer focus.
 Confirmation that your company is committed to quality.
 May facilitate trade and increased market opportunities.
 Can increase customer confidence and satisfaction.

29. Conclusion
Good Laboratory Practices (GLP) provides a frame work
for laboratories to plan, perform, monitor, record and report
their activities. It also reflects the quality of laboratory services
during any assessments.
ISO 9000 is a series of Quality Management System (QMS)
Standards that provides guidance and tools, minimum
requirements for companies and organizations, to ensure that
their products and serives consistently meet customer’s
requirements, for consistent improvement in quality.

30. References
1. Sanjiv Kumar Jain and Inderpreet Singh Ahuja, ISO 9000 Quality
Management System: Literature review, International Journal of
Technology, Policy and Management, Vol. 12, No. 4
2. Amar Pal Singh, Quality management systems & ISO 9000
effectiveness: A review, Indian Journal of Pharmacy and
Pharmacology, Vol. 9, Issue 4, Oct-Dec 2022
3. Richard A. Becker, Erik R. Janus, and Robert E. Brackett, Good
Laboratory Practices and Safety Assessments, Environmental
Health Perspectives, volume 117, number 11, November 2009

31. 4. Herbal Drug Analysis, Analytical Pharma. & Extraction
Technology, PV Publications, Page 62-81
5. Alatgi AC, Chougule SB., “Good laboratory practice”, Journal of
Evolution of Medical and Dental Sciences 2015; Vol. 4, Issue 103,
December 24; Page: 16901-16906
6. Good Laboratory Practice, by European Chemical Industry
Ecology and Toxicology Centre (ECETOC), Monograph No. 1,
Brussels October 1979Good Laboratory Practice. by G.E. Paget,
MTP Press Limited, Lancaster 1979
References

32. THANK YOU