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

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

 

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

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. 

 

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

 

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.

 

            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  

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.