Final term exam of quality control A

Answer only 8 of the following

1-What are The dimensions of Quality ?
2-Enumerate characteristics features of the drug that
determined for its Quality control?
3-Write the components of quality control?
4- Define the following
a- Quality of pharmaceutical practice viewing
b-Standard operating procedures (SOPs)
c- Good laboratory practice (GLP)
d-Good manufacturing practice (GMP)
5-Writ the type of sample in sampling procedure ?
6-What are the classification of errors in pharmaceutical
analysis and give examples for one of them?
7-Illustrate how can you minimize the systemic errors?
8-Mention the Purpose of stability testing?
9-Illustrate routes of drug instability in dosage form?
10- What are the methods that achieve the instability
indicating assay methods?
11- To which the validation testing carried out?
12- Write the methods used for validation approaches of
analytical method?
13- What are the steps of typical validation process for
new analytical method?
14- Write the parameters of ICH method validation?
 Final term exam of quality control A
15- Write the parameters of USA method validation?
16- Brifly explain addition standard method and internal
standard method?
17- What are the purpose of documentation?
18- What are the importance of good doucumentation?
19- Writ types of documents ?
20- Why good documentation is essential?
21- What are the observation arising from poor
documentation?
22- Writ tips on good documentation practice?
23- List the most common types of documentation?