2.What is Good Laboratory Practice (GLP).

3.What is GLP in the experimental (non clinical) research arena.

4.Discuss the purpose of testing test item

5.Discuss the purpose of developing the principles of GLP

6.What is the common principles of GLP

7.Discuss the purpose of OECD

•Illustrate a possible organization chart of a small test facility

•In the chart must consist

1.Test facility management

2.Study director

3.Principal investigator

4.Study personnel

5.Etc

•Justify your chart

•Explain the main responsible of (test facility management, study director, principle investigator, study personnel)

•p/s: show your chart in power point form

         : present your chart on Thursday class

b.         Describe four (4) responsibilities of test facility management to ensure comply Principles of Good Laboratory Practice (GLP)

c.         Test Facility Management – should it be an individual or a team. Discuss your answer

d.         List four responsibilities of test facility management to ensure comply Principle of GLP.

e.         Describe the main responsibilities of principle investigator.

f.          Under what conditions if any is a deputy of study director allowed to sign a study plan or a final report.

g.         List out all responsibilities of study personnel.

2.            Are the notes of QA during a GLP-inspection considered as raw-data? Explain your answer.

3.            List the responsibilities of each below in quality assurance unit

        i. Quality assurance personnel

        ii.Test Facility Management

        iii. Study Director

       iv.  Principle investigator

        v.  Study personnel

4.            State three types of inspection as specified by Quality Assurance

b.         Explain two characteristics of test system facility

 

 c.         Describe two ways for handing the waste disposal.

 

d.         Discuss the purpose of facilities for handling test and reference items  

e.         Explain two (2) importance of archive facilities

 

b.         Describe four conditions of storing acid and alkali solvent which comply GLP standard.

 

c.         Illustrate four items required to be stated on the label of non-hazardous substances

 

d.         State three (3) reasons why chemicals, reagents and solution should be labelled. 

            e.         List two conditions to store dangerous drugs and medicine

 

f.         Describe the inspection equipment needed for apparatus and chemical.

 

g.         Describe the important information needed when labelling the chemical, reagents or solution.

 

h.         List six information needed when labelling Hazardous substances

 

i.          Discuss the action taken when a label is damaged, obscured, or chemicals are decanted into a new container.

 

2.            Discuss five actions should be taken when newly received animal and plant test systems.

3.            Discuss four actions should be taken when using animal as test system.

4.            Discuss the reason of test systems used in field studies should be located.

             

5.            State the reason of establishing and maintaining proper condition for the storage, housing, handling and care of biological test systems.

               

                i. The test item is supplied by the sponsor

ii. The test item applied in a vehicle

·   

2.            Describe the purpose of identifying the procedures of handling, sampling and storage.

3.            List the information needed to identify test item or reference item.

4.            Explain the condition of the storage areas for test and reference items at all test sites

5.         List eleven information contained in the test item label.

6.         Explain the conditions that must be taken into account for the situation below.

  i.          Storage for test and reference items

ii.         Areas used for specimen and sample preparation, instrumentation and for washing glassware

  

7.         State the information needed for storage containers.

8.         Discuss the reason of separation between the test item storage locations with the area containing test system.

     

 

            ii.         Based on your answer a (i), List the responsible of the person in writing Standard Operation Procedure (SOP).

 

b.         Identify the person should approved the revisions to Standard Operation Procedure (SOP) 

 

c.         List three supplements used as reference for Standard Operating Procedure.

 

d.         State two persons who should documented and acknowledged the deviation from Standard Operation Procedure (SOP) related to the study.

 

e.         Describe Standard Operating Procedure (SOP). 

 

 

f.          Describe the characteristic in written the Standard Operating Procedure (SOP).

            

g.         Discuss three (3) responsibility of Study Personnel in order to apply Standard Operating Procedure in the laboratory.

 

                                                    

h.         Discuss three (3) responsibility of laboratory management in order to apply Standard Operating Procedure in the lab 

 

i.          Explain one (1) precaution laboratory management should avoid while writing Standard Operating Procedure (SOP) guideline

            ii. Discuss you answer in a (i).

 

b.         Describe three responsibilities of study director in order to make sure the study plan can be used in the study.

 

C.        Discuss the action should be taken when generate data during conduct the study.

 

d.         Explain the way to conduct the study plan in computerized system design

 

e.         For each study, a written plan should exist prior to the initiation of the study. List six (6) contents of a study plan

 

f.          i. State the person who is responsible to sign the final report. 

ii. Explain your answer in 4 e (i).

 

            b.         Identify the person should have access to the archives.

            

c.         Discuss the action should be taken if a test facility or an archive contracting facility goes out of business and has no legal successor.

 

d.         Describe the reason why the material retained in the archives ……                         should be indexed

 

 

e.         State four documents that should be retained in the archives for the period specified by appropriate authorities.

 

f.          The facility used for the storage of records must be designed and maintained in a manner to protect the records from unauthorized access and deterioration or damage. Explain briefly five (5) facilities of archive.

 

b.         Describe the scope of the application of the principles of good laboratory practice (glp) to in vitro studies.

 c.         Define the terms below.

 i.          in-vitro studies 
ii.         Reference item

d.         Describe the responsibility of the below persons in the application of the principles of good laboratory practice (glp) to in vitro studies.

     i.          Test facility management
     ii.         Study Director

    iii.        Study personnel

e.         Explain two characteristics of test system facilities in the application of the principles of GLP to in vitro studies

 

f.          Decribe four specific areas to be inspected based on Quality Assurance in the in-vitro studies

 
g.         Describe four purposes of Cleaning and decontamination of facilities and equipment and minimising sources of contamination of test items and test systems.

h.         Explain the general concept of facilities required when doing the in-vitro studies.

 i.          Explain the facilities needed for handling test and reference item when doing the in-vitro studies.

j.          Explain the condition for test system before starting the in-vitro studies.

 k.         Describe the action need to be taken when newly received test system for in-vitro studies.

 l.          Compare between positive control and negative control of test and reference items for in-vitro studies.

 

m.        Discuss the approach for reporting the study results after doing the in-vitro studies.

                                 (15 marks)

 

b.         i. State the quantity of original versions of final reports are that can be accepted.

 

ii. Briefly explain your answer in 6a (i)

c.         i.          Who is responsible to sign the final report

                        ii.         Explain the responsibility of person in your answer c (i)