NACTE QUESTIONS AND ANSWERS | QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS | PHARMACY NTA LEVEL 5 | DOWNLOAD PDF

 i. Organoleptic properties in quality control test of tablet include

      a) uniformity of content

    b) Flow ability

    c) Content 

     d )color and odor

     e) Flow rate

ii. Specify the correct meaning of photolysis

      a) Splitting by water

      b) Combination by light

       c) Decomposition of light

        d) Hydration of pharmaceuticals

         e) Oxidation of organic compound

iii.   ……………is among the factors controlled during tableting process

       a) Elegancy

     b) Dispersion

     c) Shelf life

     d) Edibility

    e)  Softness s and friability

iv.  ……………….Are features which indicate the physical instability problems of emulsion

     a)caking

      b) changes in hardness

     c) changes in particle size

      d)coalescence/cracking

      e) changes in dissolution test


v. Which of the following is/are the likely physical instability problems of suspension? 

     a) Cracking

     b) Creaming

     C) Caking

       d) Disintegration time

        e) Phase inversion

vi. Photolysis can be prevented by 

      a) Packing in plain bottle

       b) use of black colored bottle

      c) Storage in ventilated room

     d) Cardboard outer

      e) Use of copper foils over wraps

vii. The following are among the quality control test for all tablets

     a) Content for uncoated tablet

    b) Labeling of coated tablet

     c) Uniformity of weight only

      d) Content of active pharmaceutical ingredients

       e) Disintegration but not uniformity of weight

viii.  ………………Explain the limitation and span action required in the SOP

     a) Safety

    b) Header

    c) Scope

     d) Documentation

    e) Title


ix…………….Cleary identifies the activity in the SOP

     a) Scope

      b)Title

     c) Procedure

     d) Responsibility

     e) Objectives

x. The meaning of Header…………………….

       a) Delivery

        b) Caution information

        c) Implementation of SOP

      d) Name of organization, derpatment or division

      e) Defect technique

SECTION B: MULTIPLE TRUE AND FALSE QUESTIONS

Write TRUE in correct statement and Write FALSE in incorrect statement

1. When SOP is applicable?

      i………………..When safety risks are present

     ii………………When numerous people perform the similar procedures

     iii……………….When steps and decision can be standardized

      iv…………………When outside advisers “input” is need

      v………………..When objective feedback on performance is desired

2. SOP has the following impacts

    i…………………promoting coaching

     ii……………….promote team work

     iii……………Facilitate training

       iv……………Increasing productivity

      v…………….Reduce system variation

3. In order to have control of starting and packaging of materials,the following are important factorsto be born in mind

   i…………..Sources must be know before procurement

     ii………….Storage follows after clear testing

     iii…………Release for production can be done prior sampling

     iv…………..On reception they should be sampled and tested

      v………….Outdates materials should be retained for other non sterile production

4. As in accordance to quality assurance of pharmaceutical product the SOP should where appropriate be available for the following

      i…………………pest control

     ii……………….Environmental monitoring

      iii……………….Equipment assembly and validation 

    iv……………….Recall only

    v…………………Personel matter but do not include training and qualification

5. Maintenance of equipment and machine include the following advantages

     i…………………..increase break down and there by down time

    ii………………….promote risk dangers of workers

    iii…………………increase plant life

     iv………………..maximize repair costs

      v………………...improve better product quality

6.   …………………..Are among the factors used to determine the quality of pharmaceutical product

     i……………….purity

     ii……………identity

     iii………….manufacturer

     iv…………bioavailability

      v………….compliance

7. Regarding RO system the following involved

      i………………..semi permeable membrane involved

     ii…………….permeate water and reject water are two types of water come out of system

      iii……………strong saline solution will tend to migrate to weaker saline solution 

       iv……………weaker saline solution will tend to migrate to strong saline solution

        v………………artificial pressure is applied

8. The following are correct regarding the operating principles of an Autoclave

         i………………….recommended time for sterilization of 2litre container is 30 minutes

        ii………………..sterilization time depends on volume,temperature and bioburden

      iii…………………evaporation and condensation are principle involved 

      iv…………………recommended time for sterilization of 1litre container is 20 minutes

       v…………………sterilization of material is based on the use of steam and pressure

SECTION C: MATCHING ITEMS QUESTIONS

INSTRUCTIONS

Match functions from column B with those organs in column A

PART A

COLUMN “A” ANSWERS COLUMN “B”

I.  Specification B A.  Delivery

II. Bulk product G B.   Caution information

III. Qc requirement F C.   Basis for quality evalution 

IV. Consignment A D.   The product performs is claimed

V. SOP on SOP E E.    Management of SOP

F.    Validation of test method

G.    Any product thas has completed all processing stages up                                                                                 to,but not including final packaging


PART B:              

COLUMN “A” ANSWERS COLUMN “B”

I.  Ion exchanger chromatograph E A.  Separation of particles is based on their size,shape and molecular weight

II. Gas chromatograph G B.  The individual components get differentially attached onto adsorbent

III.  Adsorption chromatograph B C.   Solid substance coated on a glass,plastic,or aluminium plates which adsorbs molecules to separated

Iv.  HPLC Chromatograph D D.  Separation is greatly improved by applying high pressure

v.    Gel filtration chromatograph A E.  Technique retains analyte molecules based on ionic interaction

F.   Is an analytical technique for separation and identifying mixtures that are either coloured or can be made coloured 

G.  Separation of compound that can be vapourized without decomposition

                

SECTION D: SHORT ANSWER QUESTIONS

INSTRUCTIONS 

This section consists of five questions

Write a readable handwrite: DIRTY WORK IS NOT ALLOWED

1.Define the following terms

a ) Good laboratory practices(GLP)…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..

            B) Validation…………………………………………………………………………………………………...................................

            c) Finish product……………………………………………………………………………………………………………………………

     2.   a) Mention four(4) common problems RO System experiences due to poor pre treatment

               i……………………………………………………………..

               ii……………………………………………………………………

              iii…………………………………………………………………..

              iv……………………………………………………………………

           b) List any five pre treatment solution/media for RO system that can help minimize problems

                   i……………………………………………………………….

                    ii……………………………………………………………….

                    iii……………………………………………………………….

                    iv………………………………………………………………

                   v……………………………………………………………… 

     3    a) List six objectives of writing SOP

           i…………………………………………………………………….

           ii……………………………………………………………………

          iii…………………………………………………………………….

           iv………………………………………………………………………..

           v…………………………………………………………………………….

            vi………………………………………………………………………….

          b) List five factors affecting the rate of drug degradation

                 i…………………………………………………………………………….

                 ii……………………………………………………………………………..

                  iii……………………………………………………………………………

                  iv…………………………………………………………………………………

                    v…………………………………………………………………………………

  4       a) Define Thin layer chromatograph and Rf value applied in planar chromatograph

           b) i. If components of a mixture travelled 96mm from the base line while the solvent had travelled                                                             12.0cm calculate Rf value

              ii. Briefly explain five procedures on how Thin layer chromatograph is carried out

                        i………………………………………………………………………..

                        ii………………………………………………………………………….

                        iii…………………………………………………………………………

                        iv……………………………………………………………………………

                        v………………………………………………………………………………    

5.    a) Mention four main types/parameters of analytical procedures to be validated

              i…………………………………………………

              ii…………………………………………………

              iii……………………………………………………

              iv……………………………………………………

      b) List five quality assurance system defects which can be found in pharmaceutical enterprises

                i…………………………………………………………….

                ii…………………………………………………………….

              iii………………………………………………………………

             iv…………………………………………………………………..

               v……………………………………………………………………

  SECTION E: GUIDED ESSAY QUESTIONS

 INSTRUCTIONS

This section consists of three questions which are supposed tobe answered in a narrative ways                                                    

1.   Explain Six importance’s of GMP in pharmaceutical manufacturing

2.   Explain eight responsibilities of head of production and quality departments

3.    Describes in process quality control (IPQC) problems in tablets

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