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Ihr seid die größten hurensöhne !!!

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1. SOP
2. Incharge SOP
3. Resource of SOP
4. Characteristic SOP
5. Responsibilities laboratory management in SOP
6. Precaution in SOP
7. Document needed before conducting study in Laboratory and explain
8. Generate data during conduct the study
9. Way to conduct the study plan in computerized system design
10. content of study plan
11. final report

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UNIT 1 GLP ( SOP & MASTER SCHEDULE) HASDA

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UNIT 1 GLP ( SOP & MASTER SCHEDULE) HASDA

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slide unit 1

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Slide GLP

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(latifah dan khairul)

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a.         Illustrate one final report titled ‘9 days of wound healing using rat’  by including the seven (7) important components that comply to Good Laboratory Practice (GLP).

(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)

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a.         Describe the purpose of studies involving in vitro test systems.

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.

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a.         Discuss the important steps for storage and retention records and materials.

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.

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a.         i. List one document needed before conducting any study in the laboratory.

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).

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a.         i.          Identify the person who should written and approved the Standard Operation Procedure (SOP).

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

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1.            Discuss the action will be taken if the below situation occur

i. The test item is supplied by the sponsor

ii. The test item applied in a vehicle

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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.

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1.            List three condition of apparatus used for the generation of physical or chemical data?

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.

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waktu mula mula belajar saya kurang faham tentang subjek ni.lame lame dah boleh faham tapi tetap ada banyak definition and term yang kene hafal. ada masa yang sama keliru dengan apa yang nak kene hafal dan faham tu.

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waktu mula mula belajar saya kurang faham tenetang subjek ni.lame lame dah boleh faham tapi tetap ada banyak definition and term yang kene hafal. ada masa yang sama keliru dengan apa yang nak kene hafal dan faham tu.

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waktu mula mula belajar saya kurang faham tenetang subjek ni.lame lame dah boleh faham tapi tetap ada banyak definition and term yang kene hafal. ada masa yang sama keliru dengan

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waktu mula mula belajar saya kurang faham tenetang subjek ni.lame lame dah boleh faham tapi tetap ada banyak definition and term yang kene hafal. ada masa yang sama keliru dengan aya tu

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waktu mula mula belajar saya kurang faham tenetang subjek ni.lame lame dah boleh faham tapi tetap ada banyak definition and term yang kene hafal. ada masa yang sama

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waktu mula mula belajar saya kurang faham tenetang subjek ni.lame lame dah boleh faham tapi tetap ada banyak definition and term yang kene hafal.

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waktu mula mula belajar saya kurang faham tenetang subjek ni.lame lame dah boleh faham tapi tetap ada banyak definition and term yang kene hafal.banyak

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Byk term yg kne hafal n kadang2 macam nak sama ja ayat dia. Terkeliru sebab byk sgt ayat , term n definition.

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First sy ingin memohon maaf kpd madam ats kelemahan sy dalm subjek ni. Berdasarkan apa yg sy belajar dr bab 1-4 dlm subjek GLP ni sejujurnya sy blh apa yg mdm ajar, tp masalh yg plg rumit bg sy adalh utk menghafal ayt yg sgt panjg trutama dlm bhasa English. :'D

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assalamualaikum.. feedback saya sepanjang belajar subjek GLP dari bab 1-4 ialah .. bagi saya banyak kena hafal.. alhamdulillah saya boleh hafal tapi memerlukan masa dan tenaga yang banyak kerana saya seorang yang agak lambat untuk mengingati sesuatu perkara dan semasa test 1 sejujurnya saya telah hafal apa yang madam suruh namun pada hari peperiksaan saya telah lupa dan byk berlaku ke 'confuse' san jawapan mana yang patut saya letak pada sesuatu soalan itu.. selain itu,saya juga agak kurang memahami beberapa terms dalam subjek ini dan itu silap saya sendiri kerana kurang study. itu sahaja setakat ini .. saya minta maaf madam saya akan berusaha lagi untuk dapat lebih baik dalam subjek ini ... fighting!!!!

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as salam madam, seperti yg madam perkatakan sebelum ini di mana madam memerlukan feedback drp kami semua. tp, sebelum itu, maafkan sy atas kelewatan memberi feedback kpd madam. so, apa yg dpt sy simpulkan setelah belajar subjek GLP dri bab 1 hgga bab 4 ni adalah , pada keseluruhannya, sy tidak dapat mnguasai sepenuhnya . contohnya, soalan soalan yang mmerlukan jawapan yg pnjg dan sukar memahami. utk soalan yang mudah memahami spt term , in shaa Allah sy dpt menguasai sepenuhnya, cuma kadang kadang sy jadi confuse bila menjawab soalan yg jwapannya lebih kurang sama. erm setakat ni, itu shajalah yg sy nak perkatakan kepada madam, jika ada terkasar bahasa dlm kata kata sy td, maafkan sy madam.. terima kasih atas segala tunjuk ajar madam. heee :)

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Ape yang saye dapat simpulkan, saye kurang sikit tentang menghafal. kalau terlalu bnyak hafal saye blank time exam. then, cepat confuse tentang ap yg saye hafal. bukan saye tak study tpi mybe teknik menghafal saye tak betul lagi. cara madam ajar bagi saye dah okay dah. sempoi dan senang nak communicate sebab madam tak garang. jadi, student tak takut nak tnye sebab madam baik dan always consider masalah kami. thank you madam malin.

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*( SY.N. LATIFAH SY. ISMAIL)*
First of all thank you very much to Madam Amalina yg cantik dan super duper gojes yang sudi berkongsi ilmu dgn saya dan rakan-rakan.."Sharing is caring" adalah satu catalyst yg memangkin kami utk terus berusaha dan berjaya..Sepanjang beberapa minggu ini, saya dapati proses pembelajaran dalam keadaan yg baik dan memuaskan cuma,terdapat beberapa elemen yg belum boleh saya kuasai sepenuhnya berikutan kerana beberapa  faktor yang hanya saya yang boleh memperbaikinya..Sejujurnya dalam tempoh cuti yang lama beberapa bulan yg lepas telah membuatkan saya sedikit sebanyak hilang fokus di dalam kelas dan spirit utk jadi rajin again and again sedang dipergiatkan..Akhir kata, madam is the best lecturer among the rest and kami doakan madam diberikan kesihatan yg baik dan bahagia till jannah dgn family tersayang.. dan pliz doakan saya dan rakan-rakan berjaya dunia dan akhirat..AMIN.. TQ MADAM AMALINA :)

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chapter 1 - 4:
topik ni tak susah sngat tapi bnyk kna hafal, ingat dan pham. Saya selalu confuse bila nk jwab dalam test. disebabkan subtopik dlm topik2 bnyk, jdi saya kurang ingt. :D

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Subjek ni banyak menghafal...saya bleh hafal tapi bila byak sangat saya jadi confuse dan tertukar jawapan 😅😅...maafkan saya madam ...saya akan try sedaya upaya saya utk test 2 and final nnty insyallah...saya nak mintak maaf sama takut ilmu saya x berkat...maafkan saya atas semua salah silap saya ..😁😁😁😁😁

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Subjek ni banyak menghafal...saya bleh hafal tapi bila byak sangat saya jadi confuse dan tertukar jawapan 😅😅...maafkan saya madam ...saya akan try sedaya upaya saya utk test 2 and final nnty insyallah...saya nak mintak maaf sama takut ilmu saya x berkat...maafkan saya atas semua salah silap saya ..😁😁😁😁😁

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a.         List 4 ways to handle apparatus used in the study.

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.

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a.         Describe two conditions of test facilities

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

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1.            What is the purpose of documented Quality Assurance Programme

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

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1.List three objectives of GLP

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

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•Divide 5 group :

•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

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a.         Describe three (3) responsibilities of study director.

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.