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1. What is the condition of the design of the formal stability studies for the finished product.

2. List four test recommended in photostability testing

3. List out two options are acceptable of selection of batches

4. What is the condition for stability testing of container closure system

5.  List out the test of specification

6. Explain four studies in testing frequency

7. Explain the action should be taken if any differences between the release and shelf life acceptance criteria for antimicrobial preservative.

8. Explain the action should be taken when a single primary stability batch of the finished products.

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a.         Define the term validation in the analytical method validation.

b.         Describe two situations needed for validation.

c.         Compare the differentiation between limit of detection (LOD) and limit of Quantitation (LOQ).

d.         Explain two approaches of determining LOD (limit of detection).

e.         Discuss validation of analytical procedure.

f.          List out three characteristics of validation.

g.         Describe two factors that affect the robustness in using High Performance Liquid Chromatography (HPLC).

h.         Describe two reasons perform force degradation studies.

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a.         i.          Define the term active pharmaceutical ingrediens (API).

ii.         List one example of active pharmaceutical ingredients (API).

b.         Describe three purposes of accelerated stability test on powdered raw material.

c.         Discuss the importance data from the study in addition to long term stability studies.

d.         List four methods to identify physicochemical in stability studies.

e.         Discuss the importance of accelerated stability test on formulated ………powder of raw material.

f.          Describe four techniques in the majority of natural essences are obtained by extracting the essential oil.

g.         Discuss the differentiation in term of testing between accelerated stability test on formulated extract and accelerated stability test on formulated raw material.

h.         List two methods to identify physicochemical using formulated extract as the sample

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a.         State when the post approval commitment necessary for finished product.

b.         Describe the purpose of identify the post approval commitment.

c.         Predict what happen if the data show so little degradation and so …little variability that it is apparent from looking at the data that the requested shelf life.

d.         State when the post approval commitment unnecessary for finished product.

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a.         Discuss the action should be taken

i.          when a significant change other than water loss occurs during the 6 months’ testing at the accelerated storage condition

ii.         If the finished product is packaged in a semi-permeable container

iii.        if significance change occur between 3 and 6 months testing

iv.        If significance change occurs between 3 month of testing

v.         Finished Products Intended For Storage Below -20⁰c

b.         Describe the meaning of ‘significance change’ for a finished product.

c.         What do you understand about finished products packaged in impermeable containers?

d.         Explain briefly about finished products intended for storage in a freezer

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Daripada pembentangan journal accelerated stability study. Antara perbezaan yang dapat dilihat daripada keempat-empat journal adalah:

1.  Bahan yang digunakan sama ada bahan-bahan yang telah di formulasikan ataupun raw material itu sendiri.

2. Guideline yang digunakan dalam menjalankan kajian

3. Instrument yang digunakan, sama ada HPLC sahaja, FTIR dan lain2.

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Daripada pembentangan journal accelerated stability study. Antara perbezaan yang dapat dilihat daripada keempat-empat journal adalah:
1. jenis raw material yang digunakan samaada powder,formulated powder, extract and formulated extract
2. Perbezaan daripada segi  temperature dan humidity yang digunakan bagi accelerated stability study.
3. perbezaan dripd guideline yang digunakan dalam setiap journal

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Different between accelerated stability study of journal topic is:

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Different between accelerated stability study of journal topic is:

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1.accelerated stability study use for the material is different such as powdered raw material, formulated powder, formulated extract, and extract.
2. The result of data given of each journal are different because depend on the purpose of the study
3.the data also different because the temperature use and duration are different, some of the journal use similar guideline such as ICH guideline.

~syada~

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antara perbezaan yang terdapat pada journal journal tersebut adalah
1) type of raw material use ( formulated powder, powder, extract & formulated extract)

2) duration of the accelerated study
3)type of data presentation ( graph, description, chart , etc)
4)type of evaluation on the tested sample
5) guideline used to carried out the study

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daripada pembentangan berkaitan tajuk accelerated stability studies terdapat beberapa perbezaan diantara kesemua juornal yg dibentangkan iaitu:
1) perbezaan dari segi method yang digunakan
2) Observe difference kind of parameter based on their aim.
3) present difference kind of table as their result
4) perbezaan dari segi storage condition which some of them need to be store at room temperature and some of them need to be store at refrigerat

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drpd pembentangan hari tu mengenai 4 types jornal berkaitan dgn stability on powdered raw material, accelerated stability on formulated powder of raw material, accelerted stability test formulated extract and accelerated stability test on extract.

1. terdapat perbezaan di antara storage condition for accelerated study diantara formulated and raw.

2. the temperature also different for 4 types the journal that had found.

3. setiap study of journal berkaitan pembentangan ni, saya dpt lihat setiap negara mempunyai guideline dan method yg berbeza even mereka mempunyai study yg sama.

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Daripada perbentangan journal berkaitan accelerated stability studies. Antara perbezaan yang dapat dilihat dari keempat-empat tajuk journal.

1)  form raw material yang digunakan iaitu powdered, formulated powder, formulated extract and on extract.

2) Perbezaan dari segi masa yang digunakan untuk accelerated stability testing.

3) Terdapat juga perbezaan dari segi suhu yang digunakan. ada setengah raw material yang tidak boleh didedahkan pada suhu tinggi.

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Different between the journal based on the topic
i) the form of the material that hase be testing
ii) the different time of accelerated stability test that was conducted. Some have 2 years and some using 1 year.

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ada bahagian yg tak bera

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overall faham. tp secara details kene baca sikit lagi supaya senang ingat sebab ada ayat yg susah nk ingat.

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Semua information saya paham tapi perlukan lebih pembacaan untuk lebih faham dan ingat

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all the meaning i understand. but the example and detail still make me confused.

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dalam unit 7, secara keseluruhannya saya faham topic yang diajarkan. tapi ada lagi topik yang sya belum faham sepenuhnya.

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bab 7
Secara keseluruhan, saya tak berapa faham bab 7, tapi part yang belakang saya faham sikit².

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Each of students need to choose your topic and find the journal related to the topic. Understand the journal and explain the purpose of the journal, procedure and etc which related to the stability test. Please write your name below
1. Accelerated stability test on powdered raw material
i.
ii.
iii.
iv.

2. Accelerated stability test on formulated powder of raw material
i.
ii.
iii.
iv.

3.Accelerated stability test formulated extract
i.
ii.
iii.
iv.

4. Accelerated stability test on extract
i.
ii.
iii.
iv.

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bab 6
saya faham bahagian group aliya dan group shakirah shaja..yang lain tu masih kabur2

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Secara keseluruhan saya faham bab 6

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Bab 6
Saya paham jenis-jenis storage condition untuk finished product dan kepentingan setiap storage condition seperti general cases dan lain-lain

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know the importance of suitable storage condition and suitable type of container that may effect the stability/efficacy of the finished product

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Dalam chapter ni saya tau macam mana cara storage conditon untuk finished product. lepastu tau apa yang patut dilakukan kalau ada significant change berlaku.

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Unit 6, boleh difahami tentang storage condition bagi finished product. selain itu, tahu beza antara fungsi impermeable container and semi-impermeable container yang digunakan untuk penyimpanan produk mempengaruhi bagaimana produk yang disimpan dan apa keadaan dan testing yang sesuai untuk dia.

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Semua penerangan melalui video memberi lebih kefahaman tetapi bagi group yg hanya menggunakan suara perlukan sedikit improvement dari segi kejelasan suara.

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Chapter 6 ni good. Belajar storage condition yg sesuai bg finished product. Alhamdulillah dgn task video serta soalan yg perlu ditanyakan pada setiap group menambahkan pengetahuan dan kefahaman yg lebih baik. Tq

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Dalam bab 6, saya dpt belajar memahami definisi dan kriteria “significant change”contohnya apabila ada perubahan sebanyak 5% keatas dlm aspek tertentu. Saya juga belajar mengenai macamna impermeable dan semi-impermeable mempengaruhi bagaimana produk yang disimpan dan apa keadaan dan testing yg sesuai untuknya.

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Dalam unit 6, sya faham serba sedikit tentang storage condition bagi finished product. selain itu, sya juga tahu beza antara fungsi impermeable container and semi-impermeable container yang digunakan untuk penyimpanan produk

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Understand all the information. However still not understand the 5 thing to see in significance change occurs.

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Chapter 6
Chapter 6 ni kefahaman good. Belajar storage condition yg sesuai bg finished product. Alhamdulillah dgn task video serta soalan yg perlu ditanyakan pada setiap group menambahkan pengetahuan dan kefahaman yg lebih baik. Tq

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jawapan soalan gp aliya, shada, hadi , yasmin 

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jawapan soalan gp aliya, shada, hadi , yasmin 

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SEMUA JAWAPAN YANG TANYA KAT GROUP AFIFAH SHAKIRAH RAFIDAH ALIP

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SEMUA JAWAPAN YANG TANYA KAT GROUP AFIFAH SHAKIRAH RAFIDAH ALIP

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untuk chapter 4 dengan 5 sye faham sikit . just ada sesetengah tajuk macam tenggelam timbul kefahaman tu .

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Reflection chpter 4 & 5

Stabilty commitmet stated about keep on doing the study during the period of storage prior to the stability test relevant to the study timeline itself  in order to firmly establish the re-test period. Unit 5 focues on understanding guidelines applied to stabilty studies , the reasoning of stability studies, studies conducted during the studies with description with their specification.

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Group husnina, natasya, amalin dan zakuan

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Group husnina, natasya, amalin dan zakuan

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FINISHED PRODUCT INTENDED FOR STORAGE IN REFRIGERATOR AND FREEZER

https://youtu.be/GlNbS7wNLwQ

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finished product packages in semi - impermeable containers.

https://www.youtube.com/watch?v=Q8sPYdyB_W4&rel=0

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Kesuluruhan topic 4 dan 5 dapat difahami setelah diterangkan oleh pembentang tetapi masih ada yang perlu dipelajari lebih mendalam untuk lebih faham.contohnya di topic 4 stability commitment dan bab 5 tentang specification

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finished products packages in impermeable containers

https://youtu.be/YsKHhoLe7BA

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Paham la sikit2 tapi nak madam jelaskan lagi. Part alip tak paham.

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Chapter 4&5 tak faham sgt masa present. harap madam terang balik.

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chapter 4 dan 5
Dalam kedua2 chapter saya phm kecuali bahagian yang dibentangkn oleh mat alip , saya xberapa nak paham..

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CHA

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CHAPTER 4&5
saya tak berapa faham pasal stability commitment, specification dengan testing frequency

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CHAPTER

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CHAPTER 3 saya faham setiap sub-topic untuk chapter 3

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storage condition for finished product ( general cases)

https://youtu.be/HqxDkkx0xw0

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in chapter 4 and 5
alhamdullilah i understand most of sub topic but i really hope madam explain more about specification . tq

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1. Divide 4 group
2. Based on the slide given (unit 6), discuss the topic with your friends and present in the form of video.
- group 1 - general cases
- group 2 - finished products packages in impermeable containers
- group 3 - finished products packages in semi- impermeable containers
- group 4 - finished products intended for storage in a refrigerator and freezer
3. Sent the video via padlet.
4. Each of the students need to comment or ask questions below the video (your friends video)
5. Anyone who did not comment the video will be punished!! watch out guys!!

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Unit 4
Understand but not overall. Like stability comitment.

Unit 5
Understand all but need to explain specification.

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Unit 4
Saya tak berapa nak faham sgt pasal stability comitment.

Unit 5
Overall saya faham berkenaan tajok2 di dalam chapter 5 iaitu evaluation in emea and statement, finished product, photostability testing, container closure system, specification and the last one is testing frequency

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Tak faham stability comitment

evaluation in EMEA - evaluate guna linear regression, bila batch kecil data akan di combine

finished product- untuk determine shelf life , untuk recommend storage condition

photostability testing- conducted at least one primary batch of finished product.

selection of batch - kalau stable - data at least 2 pilot scale bbaru acceptable
kalau unstable- 3 primary batchh are provided
container closure system- penting sebab container boleh affect stability of product

specification-ada physical,chemical,biological stability study.nak buat testing kena ikut monograph,prevent degradation
- overall, ada yg tak faham, ada yang faham

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UNIT 4
saya rasa saya faham tentang penjelasan topik 4  daripada kawan2 dan madam sendiri iaitu tentang stability commitment  (kalau nak buat stability, kita kena ada komitmen utk teruskan stability studies) dan evaluation in EMEA and statement/labelling

UNIT 5
saya faham sedikit tentang topik unit 5 iaitu finished product, photostability, selection of batch, container closure system  dan testing frequency. tapi untuk specification saya hanya faham yang active substance yang dah ada dalam monograph, stability test pun kena buat based on monograph.

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UNIT 4
-stability commitment (kalau buat long term data, tak cover retest period commitment kena ada
UNIT 5
-Nilai active substance melalui EMEA
-untuk mendapat appropriate result

STATEMENT LABELING
-Storage condition refer at the guideline
FINISHED PRODUCT
-related to behavior properties of the dosage form
PHOTOSTABILITY TESTING
-test on the primary batch of finish product
CONTAINER CLOSURE SYSTEM
SPECIFICATION
-Testing yg dibuat perlu  mengikut monograph
TESTING FREQUENCY
*saya paham secara overall je madam tapi tak berapa paham secara detail

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UNIT 4
learn the evaluation, statement and labeling of the stability comitment
UNIT 5
i have learn about general studies, photostability testing, selection of batches, container closure system and testing frequency

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For unit 4 & 5 .. i almost understand the topic explained by the presenter but a few sub topics that i did not catch up like stability commitment, photostability testing and specification.

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faham dan best sebab ada lakonan, lagi mudah faham :)

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UNIT 2 (REFLECTION)

Unit 2 tu faham laa jugak sbab semua presrnt dgn bagus masa kelas hr tu pastu jwb soalan tu menambah lagi kefahaman.

UNIT 3 (REFLECTION

Unit 3 faham dgn penerangan drpd madam dan lakonan di depan oleh kami. Jawab soalan lagi bertambah faham

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Unit 3 ni paham topic yang diajar.

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I understand in unit 3. The different way to test depend on the enviroment, humidity and temperature. Unit 3 has 4 different way: basic, refrigerator, freeze n general case.

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Setakat nie saya paham macam mana nak conduct active substance daripada 4 keadaan yang berbeza iaitu freezer, refrigerator, general case,dan bergantung kepada keadaan substance tu sendiri.

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Alhamdulillah. Sye faham setakat ni.

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Have 4 conditions of storage for active substance
-in general cases
-in refrigarator
-in freezer
-depends on the situation of the active substance

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-Active ingredient testing follow the EMEA
-Stress testing with it defined and test that has been done
-Have 2 way to take in selection of batch
-Container closure system that important to keep it safe and specification follow EMEA guidelines

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Unit 3 tells that there have 4 conditions of storage for active substances which are for general cases, in refrigerator, in freezer and storage below -20 degree celcius

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Unit 3 have explained all I need to know about storage of materials and details like what temperature that's going to be applied for each categories(4) situation that were standard, refrigerator, freeze and the condition of below -20 degree celcius and description on how to handle them. precisely

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Unit 3
Based on this topic that are contain with acting about the storage condition make me understand even more

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I think i understand clearly about this topic.

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i think i understand about storage condition for active substance. there were 4 storage condition that can be used to conduct stability studies which were general, freezer, refrigerator and below -20 oC. this four condition have different in temperature use and problem solving.

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Reflection for unit 3
saya belajar yang bila kita nak conduct stability studies untuk produk kita, ada empat condition yang kita boleh guna iaitu general, freezer, refrigerator dan bawah -20 degree celcius dimana empat-empat keadaan ni adalah berbeza dari segi suhu dan dari segi cara penyelesaian dan kita mestilah ikut guideline yang disediakan untuk buat stability studies

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chapter 2 focuses on EMEA guidelines, it's objective and also it's focus on active ingredient  and it's overall focus point

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Your presentation must based on the above emea guideline and present using power point
2.1.8 Stability commitment (shakirah)
2.1.9 Evaluation & 2.1.10 statement n lebelling (Husnina)
2.2 Finished product, 2,2,1 General (zakuan)
2.2.2 photostability testing & 2.2.3 selection of batches (amalin)
2.2.4 Container closure system (Afifah)
2.2.5 specification (alif)
2.2.6 Testing frequency (Zafri)

GOOD LUCK PRESENTER!!!

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1.What happen when “significanct change” occurs at any time during 6 months (for general case)?

2.What happen if significant change occurs within the first 3 months when active substances intended for storage in refrigerator

3.What should you do if active substances intended for storage in a freezer

4.Diicuss the action must be taken if active substances intended for storage below -20C

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In unit 2, know about active ingredient testing follow the EMEA guideline. Know the general information about active ingredient based on pharmacopoeial monograph. Also, the stress testing with it defined and test that has been done. How to selection of batch that have 2 way to take. About container closure system that important to keep it safe ant itspecification follow EMEA guidelines

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1.         What is active substance
2.         Explain about guidelines of active substances stability

3.         List out of stress testing

4.         Discuss the purpose of stress testing

5.         list out tewo options acceptable of selection batches

6.         Discuss the usage of container closure system in stability studies

7.         List at least two test to detect the identification of the sample that has undergo stability studies

8.         Discuss the testing frequency for long term stability testing

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Unit 2 story about the EMEA guidline which is important for chemical active substance only. The purpose is to claim the shelf life of the medicinal product. Then we have stress testing which are for drug substance and drug product. Then there are 2 selection of batches which is important for stability studies and the last one is container closure system which is necessary to maintain the quality of the active substances

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In unit 2, i had learnt about EMEA guideline for active substance, selection of batch, stress testing and container closure system. for the active substance that not describe in the pharmacopeial monograph, the stability studies are required. then, i also learnt that, the stress testing help to identify the degradation product pathway, developing suitable procedure and validation. there were two type of selection batch which are production scale batch and pilot scale batch. Lastly, the active substance should kept in container closure system for storage and distribution.