USFDAguidelines of glp for non-clinical testing laboratories.

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a seminar on… Usfda guidelines of glp for non-clinical testing laboratories.:

a seminar on… Usfda guidelines of glp for non-clinical testing laboratories. S.Susena Pharmaceutical analysis &QA SSJ COLLEGE OF PHARMACY, HYDERABAD

CONTENTS…:

CONTENTS… INTRODUCTION TO GLP WHY WAS GLP CREATED?? NEED OF NON-CLINICAL TESTING?? GLP & USFDA.. USFDA GUIDELINES OF GLP FOR NON-CLINICAL TRAILS….

WHAT IS GLP?:

WHAT IS GLP? GLP is an FDA regulation . It is defined in OECD principles as “a quality system concerned with organisational process and the conditions under which non-clinical health and environmental safety studies are planned,performed , monitored,recorded,archived and reported.

History…:

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. In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard.

WHY WAS GLP CREATED?:

WHY WAS GLP CREATED? In the early 70’s FDA became aware of cases of ( PLP ) poor laboratory practice all over the United States. FDA decided to do an in-depth investigation in 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these ( PLP ) 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 plan

FAMOUS EXAMPLE:

FAMOUS EXAMPLE 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 lotion and deodorants had developed cancer and died

Principle of glp…:

Principle of glp … To promote the development of quality test data.. Set standards for ensuring the quality,reliability & integrity of studies... To ensure good operational management… Focus on aspects of study execution( planning,monitoring,recording , reporting, archiving).

NEED OF NON-CLINICAL TESTING..??:

NEED OF NON-CLINICAL TESTING..?? DEFINATION: (NON-CLINICAL LABORATORY STUDY) Non-clinical laboratory study means in vivo/in vitro experiments in which test articles are studied prospectively in test systems to determine their safety. Donot include –studies utilizing human subjects/animal trails.

GOALS…:

GOALS… Characterisation of toxic effects with respect to target organs. Dose dependence To estimate an initial safe starting dose & dose range for human trials To identify parameters for clinical monitoring to characterise potential adverse effects that might occur during clinical trial

Glp & usfda…:

Glp & usfda … The united states FDA has rules for GLP in 21CFR58. Non-clinical trials use these rules prior to clinical research in humans. Research not conducted under these restrictions or research done outside US not conducted accordingly to the FDA rules might be inadmissible in support of NDA in US.

PowerPoint Presentation:

[code of Federal Regulat ions] [ Title 21, volume 1 ] [ CITE:21CFR58 ] TITLE 21—FOOD AND DRUGS CHAPTER 1—FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUB CHAPTER A-- GENERAL 21 CFR PART 58: GOOD LABORATORY PRACTICES (GLP) FOR NON-CLINICAL LABORATORY STUDIES.

PowerPoint Presentation:

Subpart A: General Provisions Subpart B: Organization and Personnel Subpart C: Facilities Subpart D: Equipment Subpart E: Testing Facilities Operation Subpart F: Test and Control Articles Subpart G: Protocol for and Conduct of a Non-Clinical Laboratory Study Subpart J: Records and Reports Subpart K: Disqualification of Testing Facilities

Sub part A - General Provisions :

Sub part A - General Provisions Sec58.1:SCOPE Sec58.3:DEFINATIONS Sec58.10:APPLICABILITY TO STUDIES PERFORMED UNDER GRANTS & CONTRACTS Sec58.15:INSPECTION OF A TESTING FACILITY

SCOPE…:

SCOPE… This part includes good laboratory practices for conducting non-clinical laboratory studies that support /intended to support applications for research or marketing permits for products regulated by FDA including food and colour additives, animal food additives, human and animal drugs, medical devices for human use, biological products and electronic products. Compilance with this part is intended to assure the quality and integrity of the safety data filed under sections of Food,Drug and Cosmetics Act.

Definations…:

Definations … Act Test article Control article Non-clinical laboratory study Application for research or marketing permit

PowerPoint Presentation:

Sec. 58.10 Applicability to studies performed under grants and contracts  When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the FDA utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part. 16

PowerPoint Presentation:

Sec. 58.15 Inspection of a testing facility A testing facility shall permit an authorized employee of the FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect all records and specimens required to be maintained regarding studies within the scope of this part. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken. The FDA will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection. 17

SUBPART–B: Organization and Personnel :

SUBPART–B: Organization and Personnel 58.29 Personnel Every individual in testing facility Should have education,training,expirence . Maintain current summary of job , Shall be sufficient in number, Shall take neccesary personal sanitation,health precautions to avoid contamination of test systems. Shall clearly understand the functions they are to perform. 18

testing facility management…:

testing facility management… 58.33 Study Director “ A scientist / proffesional of appropriate education,training , experience” Responsible for overall technical conduct of the study, Interpretation, analysis, documentation & reporting of results. Single point of study control. 58.35 Quality Assurance Unit “A independent personal responsible to assure the management( I,e -facilities, equipment, personnel, methods,practices,records and controls are in conformance with the regulations in that part.” 19

PowerPoint Presentation:

FACILITIES… 58.41 General “Each testing facility shall be of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.” Animal care facilities Animal supply facilities Facilities for handling test and control articles Laboratory operation areas Specimen and data storage facilities 20

PowerPoint Presentation:

EQUIPMENT… 58.61 Equipment Design “ Equipment used in ... shall be of appropriate design and adequate capacity ...” 58.63 Maintenance and Calibration (a) “The written standard operating procedures ...” (b) “Written records shall be maintained ...” Log book Not for G LP use. 21

Equipment:

Equipment Verification (Testing): external check of equipment accuracy (e.g. check balance accuracy against weights at laboratory- no adjustment )‏ Calibration: equipment is adjusted based on comparison to certified or known reference materials (e.g. balance adjusted after comparison to certified weights by trained professional)‏ Standardization: comparison with similar equipment (e.g. use two thermometers of similar design to compare readings)‏ 22 Verification ?? Calibration ? Standardization ?

Standard Operating Procedures (SOP) :

23 Standard Operating Procedures (SOP) Sec 58.81: STANDARD OPERATING PROCEDURES : (a) A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study.” 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. SUBPART E- FACILITIES TESTING OPERATION:

Standard Operating Procedures (SOP) : :

24 Standard Operating Procedures (SOP) : SOPs should accurately reflect how routine tasks are performed Routine inspection, cleaning, maintenance, testing and calibration. Actions to be taken in response to equipment failure. Reviewed on regular basis.

Animal care::

Animal care: There should be SOP’s for housing, feeding, handling and caring of animals. Diagnosis, authorizations of treatment of treatment, description of treatment, each date of treatment shall be documented & retained. REAGENTS and SOLUTIONS: Reagents and solutions in laboratory areas shall be labelled to indicate identity, titer or concentrations, storage requirements and expiration date.

Subpart f-test and control articles::

Subpart f-test and control articles : Test and control article characterisation : the identity , strength, purity and composition or other characteristics which will define the test or control articles shall be determined for each batch & documented. Method of synthesis, fabrication, derivation of the articles shall be documented by sponsor /testing facility. Procedures shall be established for proper handling. Distribution is made in a designed manner to prevent possibility of contamination,deteriotation and damage.

PowerPoint Presentation:

SUBPART G- PROTOCOL FOR AND CONDUCT OF A NON-CLINICAL LABORATORY STUDY: 58.120 Protocol “Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study.” 58.130 Conduct of a Non-clinical Laboratory Study “The nonclinical laboratory study shall be conducted in accordance with the protocol ” 27

SUBPART J- RECORDS AND REPORTS::

SUBPART J- RECORDS AND REPORTS: 58.185 Reporting of Non-clinical Laboratory Study Results “A final report shall be prepared for each nonclinical laboratory study Which include a detailed documentation of how whole study carried out by the testing facility ...” 58.190 Storage and Retrieval of Records and Data “All raw data, documentation, protocols, final reports, and specimens ... Generated as a result of the study shall be retained and shall be orderly stored in archives.”

What happens if a workplace does not comply with federal GLP standards?:

29 What happens if a workplace does not comply with federal GLP standards?

Subpart k- disqualificat ion of testing facilites:

Subpart k- disqualificat ion of testing facilites Grounds of disqualification : The commissioner may disqualify a testing facility upon finding: The testing facility failed to comply with one or more of the regulations. Non-compliance adversely affected the validity of the non-clinical laboratory study.

Consequences of Non compliance…:

31 Consequences of Non compliance… The FDA states the following consequences of noncompliance: The commissioner will send a written proposal of disqualification to the testing facility A regulatory hearing on the disqualification will be scheduled If the commissioner finds that after the hearing, the facility has complied, then a written statement with an explanation of termination of disqualification will be sent to the facility Thus, if it can be shown that such disqualifications did not affect the integrity and outcome of the study itself, or did not occur at all, then the study may be reinstated at the will of the commissioner

Upon Disqualification…:

32 Upon Disqualification… If the commissioner finds that the facility showed a noncompliance, any of the grounds after the hearing, then a final order of noncompliance will be sent to the facility with explanations If a testing facility has been disqualified, any studies done before of after the disqualification will need to be determined as essential to a decision (acceptable or not) If the study is determined unacceptable, then the facility itself may need to show that the study was not affected by the noncompliance that led to the disqualification Once finally disqualified, the facility may not receive or be considered for a research or marketing permit and the study is rejected.

Upon Disqualification…coNtd,.:

33 Upon Disqualification… coNtd ,. The commissioner may notify the public and all interested persons, including other federal agencies the facility may have contacted The FDA may ask the other agencies to consider whether to support the facility or not under the disqualification Civil or criminal proceedings may occur at the discretion of the commissioner Fines of up to $50,000 if one knowingly commits crime and/or 1 year imprisonment~ for registration applicants and producers Fines up to $5,000 all others~ civil penalty after failing to improve after a minor violation warning was issued~ only those involved in testing will be given civil penalties Those involved in the distribution or sales will be assessed more heavy penalties, such as criminal penalties

Upon Disqualification…:

34 Upon Disqualification… The FDA may turn it over to the federal, state or local law enforcement The facility’s sponsor may terminate or suspend the facility from doing any non- clinical study for a permit The sponsor is required to notify the FDA in writing within 15 working days that the facility is to be suspended or terminated and why

Reinstatement of a Disqualified Facility::

35 Reinstatement of a Disqualified Facility: The commissioner will inspect the facility and determine if it shall be reinstated If it is reinstated, the commissioner is required to notify all persons that were notified of the disqualification including the facility itself

Conclusion::

Conclusion: These Regulations specify minimum standards for the conduct of safety testing to achieve great results with minimal adverse effects. The Principles may be considered as a set of criteria to be satisfied as a basis for ensuring the quality, reliability and integrity of studies, the reporting of verifiable conclusions, and the traceability of data.

Refrences::

Refrences : http ://www.fda.gov/oc/gcp/guidance.htm http://www.clinicaltrials.gov/ http://www.fda.gov/oc/ohrt/irbs/websites.html http://ohrp.osophs.dhhs.gov/ http://privacyruleandresearch.nih.gov/ http://en.wikipedia.org/wiki/ICH-GCP Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development -2nd ed., WHO Library Cataloguing-in-Publication Data, 2nd ed., 7,15-20 OECD Principles of Good Laboratory Practice (as revised in 1997)" . OECD Environmental Health and Safety Publications ( OECD ) 1 . 1998. http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_37465,00.html . Schneider, K (1983(Spring)). "Faking it: The case against Industrial Bio-Test Laboratories" . Amicus Journal (Natural Resources Defence Council): 14-26. http://planetwaves.net/contents/faking_it.html

Refrences::

Refrences : Tweedale , AC (2011). "Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A". J Epidemiol Community Health (BMJ Group) Online First: 15 February 2011 . doi : 10.1136/jech.2010.127761 . Webster, Gregory K. et al. (2005). "JALA Tutorial: Considerations When Implementing Automated Methods into GcP ". Journal of the Association for Laboratory Automation ( Elsevier ) 10 (3): 182–191. doi : 10.1016/j.jala.2005.03.003

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