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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 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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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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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 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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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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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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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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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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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.Define stability testing

2.What is the objectives of the guideline

3.What is the scope of the guideline

4.Name 3 of the environmental factors that affect the quality active substances and finished products

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In unit 1 think that I understand are that stability testing has an authority to control test. Then know that variety of environmental factors is a fact stability testing is to provide evidence on how the quality of an active substance.

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unit 1 tell us that there is a few guideline that can be followed to carry out the stability testing,in unit 1, it also has the objective of the stability test and what information that we want to gain after doing the stability test.  I understand more when madam elaborate the points in a simple way even though there is no slides for today's class :D

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Unit 1
I understand about what it stability studies actually are that ensure the quality of the product can be claim. I also know about the type of guideline which are ICH, EMEA, WHO and FDA. I also getting know about the objective of the stability studies which one of them are to ensure the suitable storage for the product.

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In unit 1 think I understand what is stability study, the objective of stability study and information about the topic.

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in chapter 1 i know what is the stability testing , the important or objective of the stability testing and the environment factor that can effect the quality of product which is temperature , humidity and light.

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in unit 1, i had learnt about the meaning of stability study, the aim of stability study, why stability study is important in production of product. other than that, i also learn guidelines used for stability studies which is EMEA, WHO and ICH. besides, from unit 1 i learn that there is several factors involved in stability studies which is temperature, light and humidity.

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In chapter 1, i have learn and understand about what is stability studies and what the important of the stability testing in the industrial to ensure the quality and other thing. Besides, i gain a new knowledge about several guidelines such as WHO, EMA, HIC and more.

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in unit 1, i had learnt and understand about what is stability studies and the important doing stability test on product before released in market. the main important is to ensure the quality of product, and the other is to determine the suitable  storage of product. i also know a few factor that can effect the quality of product such as temperature, humidity and light through stability testing. Besides, there are a few guideline such as WHO and EMEA that can be followed when doing stability studies.

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unit 1 , the stability studies was use to control the quality of product and it very importance things to release the product into the market. it have a guideline to be follow in the stability studies such as WHO, EMEA  and ICH. there are some factors that effect the stability studies such as temperature and light

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The stability studies was done for many reason. One of them is too know the quality of the product and and also to know it safety product. In stability study, must follow guideliness from FDA, WHO, ICH and EMEA. So the stability studies very improtant to make sure the product quality, safety, effectively and much more.

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Alhamdulillah, I have learnt overall of the chapter 1. I  preferably understood the factors that can effect the quality or the stability of  an active substance or finished product and also the guidelines that must be follow for herbal drug preparations and herbal medicinal products

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for 18/7/2017 class (based on below pdf)
2.1 Active substance & general (Zafri )
2.1.2 Stress testing  (Alif )
2.1.3 Selection of batches (Yasmin)
2.1.4 Container closure system & 2.1.5 Specification (Syada)

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Syada
In chapter 1, i learn about generally about stability studies...to know the quality of the product. To know the quality of the product need to make test. We also learn the main guideline that has been used is ICH for stability studies...

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unit 1, overall i understand the basic thing about the stability study and i know the guideline that we must follow is from the EMEA and i know a few factor for the stability study that we need to consider and the objective of the stability study and the EMEA

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unit 1 revolves around understanding the concept of stability study and the law it represents

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unit 1 revolves around understanding the concept of stability study and the law it represents

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in chapter 1 , i have learned about the stability study that must be performed to the product before released in the market. In stability study, there are many guideline that have to been followed. But in our syllibus, we learned EMEA guideline. There are also several environmental factors that can affect the quality of the active substances and finished products. In the simple word, the stability study is perform to ensure the quality of product.

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unit 1 have cover about stability study, factor affecting stability. also, there are guidelines that need to be followed on stability studies such as EMEA and WHO. And on unit 1 i can say that i can understand most of the sub topic and can be improvised if i do some revision

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Unit 2
for unit two i have learn about the European Medicine Agency or EMEA guideline for active substance which covered the basic information, the stress testing, the closed container system and selection batches.  from i see, all of the guideline must refer first whether the information is mention on the pharmacoephia and have a few option on the guideline that we can choose whether it is mention or not in the pharmacoepia or monograph.

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unit 2
In this chapter, i have learn about EMEA or also known as European Medicine Agency. Besides, i also clearly understand about the stress testing that involved in stability testing with the objective to evaluate the degradation pathway and developing and validation of the analytical procedure used for drug product.

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Rabiatul shuhadah binti ramli
in this chapter I was learned and understood well about EMEA guidelines that describe about active substance, stress testing, selection of batch,  container closure system and specification what  the procedure used, what result that accepted, what effect could be.

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In this chapter, i had learned the Emea guideline, there are the general principle the guideline about the active ingredient,stress testing,selection of batch,and lastly a container closure system

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based on the presentation on last Tuesday, i understand about the active substance based on Europian Medicine Agency (EMEA). it describe about the active substance that are not describe in pharmacopeal monograph need stability studies. then, we also get to know the stress testing that can help identify degradation product pathway, validation and developing suitable analytical procedure. next is get to know that there are 2 type of selection of batch and the last one function of container closure system also the specification of the drug based on EMEA

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The EMEA  i learn about the guidelines for active substance. The active substance that do not have a stability studies in the monograph or pharmacopiea have to do some testing. There a test in the EMEA guidelines, which the stress testing for describes degradation of product, the selection batch which have 2 type for large and small scale. The last is the container closer for product.