glp ppt

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good lab practice

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Good Laboratory Practices:

Good Laboratory Practices BY. Mahendra Singh Amit verma Alok kr vishwakarma Bipin katiyar M.Pharm(p’ceutics) PSIT, kanpur

Slide 2:

What it is ? This is an organisational process under which non clinical health/ environmental safety studie’s are planned,performed,monitered,recorded &reported.

WHY WAS GLP CREATED?:

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

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 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.

Slide 5:

GLP PRINCIPAL Organization and personal A) Management responsibility – To ensure that qualified person, appropriate facility, equipment and material are available Maintain the record of qualification, tanning, experience and job description for each professional and technical individual. to ensure that heath and safety precaution are applied according to national or international regulation. to ensure that SOP are stabilized and followed. maintain copies of all study plan. maintain a historical file of all SOP.

Slide 6:

B) Study Director responsibility should agree to the study plan to ensure all data generated are fully documented and recorded Sign and date the final report to indicate acceptance of responsibility for the validity of the data. to ensure that after termination of the study the study plan the final report raw data and supporting material are transferred to the archive's C) Study director : those person which are responsible for overall conduct of study . D) Principal Investigator The Principal Investigator is the primary individual in charge of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project. .

Slide 7:

E) Study Personnel : means an experiment or set of experiment in which a test substance is examine to obtained data on it’s properties and/or it’s safety with respect to human health and environment.

Q.A.:

Q.A. It covers all the aspects during manufacturing that directly,indirectly affect the over all product quality

Responsibilities of the QA Person:

Responsibilities of the QA Person Study plan & SOP are available to the QA person Periodic inspection of the test facilities Reported to the management & study director Review to the final report to confirm that the method procedure & observations are accurately described Sign to the final report in which date inspections were made & date finding were reported to the management & study director

3. Facilities :

3. Facilities

Facilitie’s for Test and Reference Substance:

Facilitie’s for Test and Reference Substance The storage of test substances and reference substance’s are separate area to prevent contamination. 4.Equipment reagent’s & material Equipment and used in studies should not interfere with the test system’s REAGENT’S - 1 -Reagent should be lebelled 2 -Appropriate indicate source concentration, stability information which include manufacturing date, expiry date & storage instruction’s

Test System:

Test System A) Physical/chemical B) Biological A) Physical/chemical:- apparatus used for the generation of physical/chemical data should be appropriate design & adequate capacity Reference sustance used to assist in ensuring the integriety of the physical/chemical test B) Biological:- Proper conditions should be established & maintained for the housing, handling & care of animal, plant,microbial as well as other cellular and sub-cellular system in order to ensure the quality of the data

Slide 13:

Newly received animal & plant test system should be isolated until their health status has been evaluated if any unusual mortality or morbidity occurs this lot should not be used in studies when appropriate humanely destroyed Record of source, date of arrival & arrival condition should be maintained All information needed to properly identify the test system should appear on their housing or containers The diagnosis & treatment of any disease before or during a study should be recorded

Test & Reference Substance :

Test & Reference Substance A) recipiet, handiling, sampling & storage records including substance characterisation , date of receipt , quantities received & used in studies should be maintained Handling , sampling ,and storage procedure should be identified in order that the homogencity and stability is assured to the degree possible & contamination or mix-up are precluded Storage containers should carry identification ,information, earliest expiration date & specific storage instructions.

Slide 15:

SOP (standard operating system)

Performance Of The Study:

Performance Of The Study 1) for each study a plan should exist in a written form prior to initiation of the study 2) the study plan should be retained as raw data 3) all changes ,modification or revision of the study plan as agreed buy the study director including justification should be documented, signed dated by the study director and maintained with study paln

Content of the study Plan:

Content of the study Plan A – descriptive title B – a statement which reveal’s the nature & purpose of the stydy C – information of the test substance by code or name D – the reference substance to be used E – name & address of the sponsor F – name & address of the test facility G - name & address of the study director H – the date of agreement of the study plan by signature of the study director

9. Reporting of result:

9. Reporting of result 1) the final report should be prepared for the study 2) the use of the international unit system (S.I.) is recommended 3) the final report should be signed & dated by the study director 4) correction and addition to a final report should be in the form of an amendment. The amendment should clearly specify the reason for the correction or addition and should be signed and dated by the study director.

10. Storage of records and reports:

10. Storage of records and reports The following should be stored for the period specified by the appropriate authorities 1) the study plan ,raw data , samples , specimen and final report of each study 2) record of all inspection’s and audit performed by the QA program 3) summary of qualification , training experience and job description of personnel 4) record and report of the maintenance & calibration of the equipment 5) historical file & SOP

References:

References http://www.sjsu.edu/faculty/chem55/55glpout.htm http://www.labcompliance.com/tutorial/glp/default.aspx?sm=d_a UGA Office of the Vice President for Research Wikipedia

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THANKS

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