Good Laboratory practice

Category: Education

Presentation Description

history, scope, objective, purpose, principles and fundamentals of GLPs.


Presentation Transcript


GOOD LABORATORY PRACTICES (GLPs) Created By: Ravi Mistry M.Pharm QARA 2 nd Sem L. J. Institute Of Pharmacy, ahmedabad Guided By: Darshil Shah Assistant Professor Department Of QARA 1


CONTENT Introduction History Why GLP? Standard approach Scope Objective/Purpose Mission Of GLP The Principles Of GLP In General Fundamentals Of GLP Summary References 2


INTRODUCTION GLP is a FDA regulation. Definition : GLP is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. GLP is sometimes confused with the standards of laboratory safety like wearing safety goggles. 3


HISTORY GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978 . Although GLP originated in the United States, it had a world wide impact. Non-US companies that wanted to do business with the United states or register their pharmacies in the United States had to comply with the United States GLP regulations. They eventually started making GLP regulations in their home countries. 4


WHY WAS GLP CREATED? In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. FDA decided to do an in-depth investigation on 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were: Equipment not been calibrated to standard form, therefore giving wrong measurements. Incorrect/inaccurate accounts of the actual lab study Inadequate test systems 5


CONTI… One of the labs that went under such an investigation made headline news. The name of the Lab was Industrial Bio Test. This was a big lab that ran tests for big companies such as Procter and Gamble. It was discovered that mice that they had used to test cosmetics such as lotion and deodorants had developed cancer and died. Industrial Bio Test lab threw the dead mice and covered results deeming the products good for human consumption. Those involved in production, distribution and sales for the lab eventually served jail time. 6


STANDARD APPROACH FDA decided a standard approach was required…To ensure quality, integrity & reproducibility of data. The O rganisation for E conomic C ooperation and D evelopment ( OECD ) formulated the first worldwide OECD Principles of GLP 1981 ( revised in 1997) To avoid non-tariff barriers to trade To promote mutual acceptance to non-clinical safety test To eliminate unnecessary duplication of experiments ISO ( I nternational O rganization of S tandardization) is a worldwide federation of national standards from 130 countries. 7


SCOPE GLP should be applied to the non-clinical safety testing of test items contained in: Pharmaceutical product Pesticides product Cosmetic product Food additives Feed additives Industrial chemical 8


OBJECTIVE/PURPOSE To promote the development of quality and validity of test data used for determining the safety of chemicals and chemicals product. Makes sure that the data submitted are a true reflection of the results that are obtained during the study. Promotes international acceptance of tests. Also makes sure that data is traceable. Help scientists to obtain results which are: Reliable Repeatable Audible Recognized by scientists worldwide 9


MISSION OF GLP Test systems Archiving of records and materials Apparatus, material and reagent facilities Quality assurance programs Performance of the study Reporting of study results Standard operating procedures (SOPs) Personnel and test facility organization 10


THE PRINCIPLES OF GLP IN GENERAL Concerned with how we organize our laboratories and how we organize our studies. Addresses responsibilities for managing people, facilities and equipment for good science Concerned with how we plan, perform and report our experiments and studies Importantly it does not interfere with the ability of scientists to make scientific decision 11


GLP PRINCIPLES Test facility organization and personnel Quality Assurance (QA) program Facilities Apparatus materials and reagents Test systems Test and reference items Standard Operating Procedures (SOP’s) Performance of the study Reporting of study results Storage and retention of records and materials 12


FUNDAMENTALS OF GLP Resources : Personnel, Facilities & Equipment Rules : Guidelines, Procedures, Protocols/Study Plans Characterization : Test Article, Identification, Quality Test System Documentation : Raw Data, Final Report, Archives Quality Assurance : Advise, Audit/ Inspection/Training 13


RESOURCES Personnel : qualified, special training, good scientific practice. Facilities (Buildings and Equipments): appropriate facilities equipment calibrated & standardize 14


RULES Guidelines - Proposal Study Plan/Protocols - Experimental design, protocols Standard Operating Procedures (SOP) - documented procedures describe how to perform tests or activities normally not specified in detail in study plans or test guidelines. Test articles : subject of a study Bulk test article Preparation of dose-form Chemical analysis Chemicals, reagents, and solutions should be labeled concentration, expiry date storage, source, name & preparation date etc.   15


CHARACTERIZATION Test systems (any biological, chemical or physical system or a combination) Proper conditions, Storage , Housing, Handling and care Records of source, Date and condition of arrival Appropriate identification 16


DOCUMENTATION Raw data and data collections Who, What, How, When, coding Computer and computer validation : used for the generation, storage and retrieval of data Study report Archives 17


RECORD DATA Data should be recorded :  Directly Promptly Accurately Legibly Should be signed and dated 18


REPORT CONTENTS Name & address of test facility Dates of study (start and finish) Name of Study Director Study objectives Test article & system details Methods Results/statistics Summary of findings Discussion References 19


ARCHIVES What is left when study is over? Study plan Raw data Specimens (not forever?) Final report QA documents Personnel records Facilities/equipment qualification records Historical SOP file 20


QUALITY ASSURANCE Quality Assurance : The sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Documented quality policy Compliance with GLP The head of laboratory is responsible for schedule & conduct of audit. Manager will be responsible to maintain all records & protocols of the analysis which are being checked by audit team. Should be carried out by competent personnel to meet regulatory requirements. Any non compliance reported in the audit should be analysed & CA should be documented. 21


MANAGEMENT REVIEW At least once in 12 months to cover Internal & external audit report Complaints & customer feedback received from laboratory customers Training records of the staff. Other laboratory requirements 22

What happens if a workplace does not comply with federal Good Laboratory Practice standards?:

What happens if a workplace does not comply with federal Good Laboratory Practice standards? Disqualification of a Facility 23


SUMMARY Non-clinical health and environmental safety studies Physical and chemical test systems biological test systems OECD Adequate facility, trained personnel, approved procedures. Validated test methods Records- Reports, specifications, calibration SOPs Analysis of RM, In-process & FP for release Product complaints & recall 24


REFERENCES chemicals/ glp / legisl /dir/ brsum /9911.htm Div. of Scientific Investigations: Good Laboratory Practice Dr. Mohanan P.V; ”Good Laboratory Practice and Regulatory Issues”; Educational Book Centre, Mumbai; First Edition; 39 25

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