GLP and ISO 9000.pptx

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 1 st 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 Concepts of Good Laboratory Practices (GLP) GLP Principles General Rules of GLP Concepts of ISO 9000 Quality Management System ISO 9000 Certification Benefits of ISO 9001:2015 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: Pharmaceutical products Pesticide products Cosmetic products Veterinary products Food additives 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 P ractices P rinciples Test Facility Organisation and Personnel. Quality Assurance Programme ( QAP ). Facilities Apparatus , Material and Reagents Test and Reference Substances Standard Operating Procedures ( SOP) Performance of The Study Reporting of Study Results 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 M anagement S ystems 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 Q uality M anagement P rinciples 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.

19. The 7 Quality Management Principles Customer focus - Quality management primarily focuses on meeting customer requirements and striving to exceed customer expectations. 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. 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

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

21. 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 .

22. 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 .

23. How is the ISO 9001:2015 Standard Structured? ISO 9001:2015 Quality M anagement S ystems 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

24. 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

25. 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 .

26. 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 .

27. 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 .

28. 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.

29. References 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 Amar Pal Singh, Quality management systems & ISO 9000 effectiveness: A review, Indian Journal of Pharmacy and Pharmacology, Vol. 9, Issue 4, Oct-Dec 2022 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

30. Herbal Drug Analysis, Analytical Pharma. & Extraction Technology, PV Publications, Page 62-81 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 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

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