GOOD LABORATORY PRACTICE (GLP) ANJAN July

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GOOD LABORATORY PRACTICE (GLP) DR. ANJAN KHADKA DATE: 9 th July, 2012 1

Wingdings:

SEQUENCE DEFINITION HISTORY SCOPE GLP PRINCIPLES SUMMARY 2

Verdana:

DEFINITION “A quality system related with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.” 3

Lucida Sans Unicode:

HISTORY In 1970s, numerous case of laboratory malpractice, fraud as well. FDA found inaccurate, sloppy and fraudulent research studies. Became public safety issue (Industrial biotech industry and mice ) 4

Times New Roman:

1960 CPCSEA (India) under PCA act 1978 GLP official regulation by FDA 1981 OECD GLP principles 1983 1998 EPA GLP regulation OECD GLP revised History contd… Although originated in US, has worldwide impact. CPCSEA : COMMITTEE FOR PURPOSE OF CONTROL AND SUPERVISION ON EXPERIMENTATION ON ANIMALS FDA: FOOD AND DRUG ADMINISTRATION,USA OECD : ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT EPA : ENVIRONMENTAL PROTECTION AGENCY 5

Office Theme:

History contd… WHO convened a working party (Scientific working Group on GLP issues – SWG) in 1999 and 2000 to address the WHO position on GLP. WHO adopt the revised OECD Principles of Good Laboratory Practice as its official guidance for nonclinical safety testing. 6

Clip:

SCOPE The Principles of GLP should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives and industrial chemicals. Principles of GLP include work conducted in: the laboratory, the greenhouses and the field. 7

GOOD LABORATORY PRACTICE (GLP):

GLP PRINCIPLES Test facility management Quality assurance program Facilities Apparatus materials and reagents Test systems

SEQUENCE:

GLP Principles contd… 6. Test and reference items 7. Standard operating procedures (SOP) 8. Performance of the study 9. Reporting of study results 10. Storage and retention of records and materials 9

DEFINITION :

1. Test Facility Management Test facility management’s responsibilities Study director’s responsibilities Principal investigator’s responsibilities Study personnel’s responsibilities 10

HISTORY:

11

PowerPoint Presentation:

Test Facility Management’s Responsibilities The management should ensure : A sufficient number of qualified personnel A ppropriate equipment and materials Records of qualifications J ob descriptions T raining and experience of personnel Personnel understand the functions they are to perform Appropriate and Valid SOP 12

History contd…:

Test facility Management’s Responsibilities contd.. A Quality Assurance Program A Study Director and a Principal Investigator, if needed, is designated Documented approval of the study plan Purchased materials meet specified requirements Test and reference items are appropriately characterized Clear lines of communication Computerized systems 13

SCOPE:

Study Director’s Responsibilities Ensures that Raw data are documented and recorded Computerized systems are validated SOPs are followed Deviations are acknowledged Records and data are archived Sign and date the final report to indicate acceptance of responsibility 14

GLP PRINCIPLES :

Study Personnel Responsibilities Knowledge of the GLP principals Access to the to the study plan and appropriate SOP’s Comply with the instructions of the SOP’s Record raw data Responsible for the quality of their data Exercise health precautions to minimize risk Ensure the integrity of the study 15

GLP Principles contd…:

Principal Investigator’s Responsibilities The Principal Investigator will ensure the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice. 16

1. Test Facility Management:

2. Quality Assurance Program Documented Quality Assurance Program (QA) Designated individuals as members of the QA team directly responsible to the management QA members not to be involved in the conduct of the study. 17

PowerPoint Presentation:

Quality Assurance Program contd… Responsibilities of the QA Personnel: Access to the updated study plans and SOP’s Documented verification of the compliance of study plan to the GLP principals Inspections to determine compliance of the study with GLP principles. Three types of inspection: Study-based inspections Facility-based inspections Process-based inspection 18

Test Facility Management’s Responsibilities :

3. Facilities Suitable size, construction, segregation Animal care and supplies Test & control products maintained in a secure area Operating suite Equipment 19

Test facility Management’s Responsibilities contd.. :

Facilities contd … Specimen & data storage Appropriately qualified personnel Handling and disposal of waste The design of the test facility should provide an adequate degree of separation of the different activities to assure the proper conduct of each study. 20

Study Director’s Responsibilities :

Apparatus of appropriate design and adequate capacity D ocumented Inspection, cleaning, maintenance and calibration of apparatus. Chemicals, reagent and solutions should be labeled to indicate identity, expiry and specific storage instructions. 4. Apparatus, Materials and Reagents 21

Study Personnel Responsibilities:

Reagents and Solutions General expiration guidelines : Dry reagents: 5 years (unless re evaluated )‏ Solvents: 1 year from date opened or 2 years from date received Solutions: Use the earliest date of components in the solution or no longer than 6 months 22

Principal Investigator’s Responsibilities :

Use Labels CHEMICAL LABEL CHEMICAL ___ ____________ ________ CHEM ID #______________________________ _ DATE RECEIVED:___________________________ DATE OPENED: ____________________________ EXPIRATION DATE __ _ _______ STORAGE______ SOLUTION LABEL CONCENTRATION_____________________ SOLUTION____________________________ FROM CHEM ID#_____________________ DATE PREPARED_____________________ EXPIRATION DATE______ STORAGE______ 23

2. Quality Assurance Program :

5. Test Systems Physical and chemical test systems Appropriate design and adequate capacity of apparatus Integrity of physical/chemical test systems Biological test systems Proper conditions for storage, housing, handling and care Isolation of newly received animal and plant test systems Humanely destruction of inappropriate test systems 24

Quality Assurance Program contd… :

Records of source, date of arrival, and arrival conditions of test systems Acclimatization of biological systems to the test environment Proper identification of test systems in their housing or container or when removed Cleaning and sanitization of housings or containers Pest control agents to be documented Avoid interference from past usage of pesticides 25 Test systems contd…..

3. Facilities:

Receipt, handling, sampling and storage Date of receipt, expiry date, quantities received and used in studies, etc.. Handling, sampling and storage procedures Identification information on storage containers 26

Facilities contd…:

Characterization Identification of each test and reference item Identification of each batch of the test or reference items Batch number, purity, composition, concentration, etc.. Cooperation between the sponsor and the test facility 27 Test and Reference items contd…

4. Apparatus, Materials and Reagents :

Test and Reference Items contd… Verification of identity of the test item Known stability of test and reference items Stability of the test item in its vehicle (container) Experiments to determine stability in tank mixers used in the field studies Samples for analytical purposes for each batch 28

Reagents and Solutions:

7. Standard Operating Procedures (SOP) “Documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines .” Approved SOP’s to ensure the quality and integrity of the laboratory data Deviations from SOP’s to be acknowledged by the study director 29

Use Labels:

Standard Operating Procedures contd.. SOP’s for Test and reference items Receipt, identification, labelling, handling, sampling, storage Apparatus Use, maintenance, cleaning, calibration Computerized systems Validation, operation, maintenance security, change control, back-up Materials, reagents and solutions Preparation and labeling 30

5. Test Systems:

Standard Operating Procedures contd … Record keeping, reporting, storage and retrieval Coding system, data collection, preparation of reports, indexing system, handling of data Test system Room preparation, environmental room conditions, receipt, transfer, identification, test system preparation, observations etc… Quality Assurance Procedures Operation of QA personnel 31

Test systems contd…..:

8. Performance of the Study Study plan Written plan, verified for GLP compliance, approved by the study director and by the management Approval of amendments by dated signatures Deviations to be explained and acknowledged 32

PowerPoint Presentation:

Performance of the Study contd.. Content of the study plan Identification of the study Title, nature and purpose of the study, test item identity, reference item used, etc.. Information concerning the sponsor and facility Names and address (sponsor, test facility, study director) Approval dates of the study plan, estimated starting and completion dates, etc.. Reference to test methods Records 33

Test and Reference items contd…:

Performance of the Study contd… Conduct of the study Identification of each study The study to be conducted in accordance with the study plan Data generated to be recorded directly and accurately Changes in the raw data not to obscure the previous data Identification of electronic data 34

Test and Reference Items contd…:

9. Reporting of Study Results Final report for each study Scientists to sign and date their reports Approval by the Study Director Corrections, additions, amendments to be signed and dated by the study direc tor Content of the final rep ort Identification of the study Descriptive title, identification of the test and reference item, purity, stability. 35

7. Standard Operating Procedures (SOP):

Reporting of Study Results contd… Information on sponsor and test facility Experimental starting and completion dates A Quality Assurance Program Statement Description of materials and test methods Results Including uncertainties, level of significance Evaluation discussion and conclusions Storage (of samples, reference items, raw data, final reports, etc..) 36

Standard Operating Procedures contd..:

10. Storage and Retention of Records and Materials What to retain in archives The study plan, raw data, samples Inspection data and master schedules Qualification, training experience, job description Maintenance and calibration data Validation data SOPs Environmental, health & safety monitoring records 37

Standard Operating Procedures contd…:

Storage and Retention of Records and Materials contd… Retention period to be defined if to dispose before expiry The justified and documented index of materials retained in the archives Controlled access to the archives In case laboratory goes out of business archives transferred to the relevant sponsors(s). 38

8. Performance of the Study:

Record retention (shortest acc. FDA ) ≥ 2 year after FDA marketing clearance ≥ 5 year after data submitted to FDA in support of marketing application ≥ 2 year after Sponsor decision not to proceed with marketing application Wet specimens hold as long as viable Records transferable with written FDA notification 39

Performance of the Study contd..:

SUMMARY Good laboratory practice can be considered as essentially tidiness, cleanliness, hygiene and common sense. Describes good practices for non-clinical lab studies that support research or marketing approvals for FDA-regulated Products. Common principles for GLP facilitate the exchange of information and prevent the emergence of non-tariff barriers to trade, while contributing to the protection of human health and the environment. 40

Performance of the Study contd…:

http://www.oecd.org/officialdocuments http://www.labcompliance.com/tutorial/glp/default.aspx?sm=d_a http://www.docstoc.com/docs/18191459/Good-Laboratory-Practices Wikipedia Acibadem University Faculty of Medicine Department of Medical Microbiology, Turkey 41 Reference

9. Reporting of Study Results:

THANK YOU 42

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