Wednesday, December 29, 2010

Manufacturing lec/lab Pre-Mid Exam Outline

Pharmaceutical Manufacturing Outline
Pre-mid Examination  2nd sem. Year 2010-2011

Instruction will be given on the day of the exam.(either identification/multiple choice)
Test I:??
--------- 1. High resistant borosilicate glass is also referred to as:
______2. General purpose soda-lime glass
______3. treated soda lime glass with sulfur dioxide and is suitable for buffered
parenteral solutions, and has a pH of below 7, & is not reactive with glass
______4.  regular soda lime glass
5. suppositories are made by:
6. rule of thumb is the principle applied for testing:
7. anteroom, which separates the sterile areas from non-sterile areas;
8. CGMP means:
9. an equipment associated with the maintenance of dust –free areas; 
10. a common lubricant added to tablet granulations:
11. this statement is true of the FIFO policy:
            a. prevents contaminations and mix- ups
            b. assures that the oldest stock of material is used first
            c. contains information regarding the activity of the component.
            d. AOTA
12. diluent of choice for chewable tablets:
13. freeze-drying is also known as:
14. most biologicals are store at this temperature:
15. a class of raw materials, which are to be subjected to tests and assays by
      the  Quality Control Department, and are not yet to be used in the production of     
      pharmaceuticals:
16. refers to the addition of an active in an unstable pharmaceutical preparations, to   
      compensate for the loss during  manufacture:
17. the following are the effects of product recalls to a drug- manufacturing firm:
18. a special technique for poorly- soluble drugs, in which it is improved by the
      addition of a water- miscible solvent, in which the drug will have increased water
      solubility:
19.  a standard document, which give instructions to the production department to
       produce a pharmaceutical product for distribution/ sale in the market ;
20. examples of primary packaging components;
21. this raw material can be used as a tablet diluent, disintegrant and binder:
22. strip- sealed tablets are evaluated for:
23. a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks or errors involved in any pharmaceutical production, which cannot be eliminated through the final  testing of the product:
24. an instrument used to check the tightness of the cap/closure:
25. a tablet processing problem characterized by the separation of the tablet into several distinct layers;
26. uneven distribution of color in tablet coating is due to :
27. a batch or any portion of a batch of drug produced by a continuous process is:
28. sealing of ampule is done by:
29. classified as sterile product although not injected into the body:
30. fever producing substances arising from microbial contamination are:
          
Test II: Draw the Organiztional Chart of a typical Manufacturing firm.(10 pts.)
Test II:Sketch the chart representing different division. Sections of Manuf’g area(5pts)
Test III: draw the chart under the raw materials and differentiate the color being used. (10 pts.)
Test III: Give the three classification of bottle defects and give five (5) examples of each.(15 pts.
                                                GOODLUCK!!!!




                       

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