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Syllabus for registration exam of Bangladesh Pharmacy council 2014

Md. Saiful Hasan
Md. Saiful Hasan

The document discusses topics related to pharmaceutical management and quality control. It outlines 15 topics, including organization structures, personnel management, inventory control, purchasing, quality control overview, terminology and validation overview, validation of analytical methods, regulations governing pharmacy practices in Bangladesh, policies and laws concerning drug manufacture and distribution, and the drug approval and registration process in Bangladesh. The topics provide a broad overview of key concepts and issues in pharmaceutical management, quality assurance, and regulatory compliance.

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r 6. Organization structures: Social organization and legal organization, the .ofi proprietorship, the general partnership, private and public limited companies, their relative advantages and disadvantages' 7. Personnelmanagement: lmportance, principles, methods, motivation, staff requirements theory. g. lnventory controt: Methods-intuitive, systematic wantbook, perpetual inventory, open-to-buy, stock, record card, economic order quality, selection of optimum methods, effect of inventory conkol' g. Purchasing: Formulating effective buying policies,- needs and desires, selecting the sources of supply, determining terms of purchase, receiving, marking and stocking of goods. 10. Quality control overview: lntroduction' general information & significance of quantitative and qualitative analyses in quality control, sampling techniques. Pharmacopoeial tests and specifications, .standardization of pharmaceuticals and formulated products, quality control systems for drugs and pharmaceuticals, causes of poor quality, theo-W and basic concepts of GLP;lSO 9000, lso 9001, lso 17025,TQM and lcH' 11. l]erminology and validation overview: lntroduction, terminology used in the validation of analytical procedures, regulatory basis for process validation. 12. Validation of analytical methods: Strategy and parameters for the validation of methods, verification of standard methods, validation of non- routine methods, analytical validation within the pharmaceutical environment, validation of standard operating procedures (soP)' 13. Retuhtions and laws governing the practices of pharmacy in Bangladesh 6fni enarmacy Ordinance 1076;, role of Pharmacy Community of Bangladesh 14. Policies, sales, regulation and laws concerning to the manufacture, possession, disiribition, sale of drugs and poisons:..The Drug Act 1940 iXXttt of 194b), The Drug Ordinance 1982, The Drug Policy 1982, The Drug iCortrog Ordinance tgSZ (OrOinance No. Vlll of 1982), its amendments, itre ttarcotics (control) Act 1990 , The National drug policy 2005 for regulation of process of registration, manufacture' distribution, sale, import' an"d export of drug in Bingladesh, The Poisons Act 1919 and related amendments 15. Approval process, format and registration of pharmaceuticals in Bangladesh. Page # o8 fr o*{ 5f ildaY &

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Syllabus for registration exam of Bangladesh Pharmacy council 2014

  • 1. :5:, E:gE Bg.E H$$F 6Egf; ;=gq'EEs-seEgE$EE*EEgEgEEgfEilEEEEE .EEE gFEEfieEE f*=E=EEE ;EE* fE;S,E E s:E ,f,EigfiEEEEEEgFEEgE-iggEEEEgESEig$ E:e E;E FEg cD+.o@F_ *tu {f? &3 w -g GS f-.E ffi 8n rr- O -l- (J Fq<tr --FJ .a. AJ xstJE >'=(Je. iEx L- F' L- jq ts hd (m Eak & h ** re ffa,al ** .*re sryd ffi* ,-a qg()c ==r/ yDlc -.EAO-c= EFIL Eoo agE9l oE-rJ rF erE4== 9o#& Er. *. (.)Ecu (rL-g =eO,=mv HEIe 5 cN lf) fi:: g H=g*rH t-$ :e,J 5sEqr *<t!oirFt =Hogtrz, Eh
  • 2. co o :tL o(f) o o_ x:trdqro-5 o -+t 6i:]'i,-0a = ' a i-cqE- E- g'9 G E =Ec ru q.8 E - tagi E b.U EE;EV' H E trE.9 cI) Y _oc o E s, U -.,'P .5 a 6 SeEf; E E f ;'EHq =H F E EgEs eF g H sr:Eg gE EsE EEEEE .g .HEgo$gEEE iE E: *5 fraE-q* sEEE EEE*g Er$E; hup EE Ef E3EEEEE EE EE;iE E,E 3E H,Eg ='o a^Ef .g ? cc EE#H--t=dHE EE oE ss.gAa l- C.i XE EfrH=Fs Eb., ., i ;$ J*gsEE l*E g gEEHt s bB -i'E= -lFc, 'eE'= :< PPF =* c,'Eogz a, EeE o, g;E EiEE;ggEg EEg E Egg* :EE=EAae1 giqri= nEsE sEEEEEsEaE$Eg3E eEEt firgES;E=gg :gEE F $t;H(JE (U q-- ;EE:.E$eBiEgEIl=g$$5 sssaE:=3$E;;u'E =s2 6 E I I$CeI .,._E F =BEE EE;E ggfl BSEIEEgffgE6iEEgg E*E Egss;sE *.flEflgggE EE E#E fE$Efi*gE EE E E# s E FE FEEESEEEEgiB J .c.i co .q .o Y |- d o; P &
  • 3. io*.(U l- >.(l)_e 1:, 0_'o-cu - l-- = (f) Ug(u !qE.Ep(I,)=a& 6(J<l)(n .C (U +-, (r, EE-i< c-:rr(J= .E iu a.e EE 8h: *Ftt H.!1 o.= +, fT, ga .F iC, C ir- ocu FUi.b o.. +-, =8- u o. iD (r0L- PE5oqoHC --;C) +=rrv =c)*r .l-, C'E OEcl=(96 .(J C} F j() L- 3ts-()(U 8,j= c,l? :oa()-o HE.9?8f; Eb6.tsc<u :sg'E -15 E5E 5Es EE E,.) )- L- l- L- H=E EEEG' itr - '!= -C C .! CL().= EEE E'E E 'a 9 IEF tri rC) :th o o) $ o- fEqEEfiEEefi;c$EgEg gE EgEgEgfi-AigE EEEE; ;sEti#Et*$figEg;g;gg $E s iE*l;:*ts rEi E s*:c. l: EEs$eSEEsE EEs *g *$i;g$t_EEgiEEEEEEHqsggEui EEitE ggErEg;g;EE iEig Es ggEEE;gg r,i + ri d *Sg 6u;.9'a. 6-b bs -,9 6 EEO-C '69 E() '= O- C)- .r- () .F' E'C C(l') CUE (l)a bg(1)<u _cg*-. L. U; J(1) EE*-, t 9tii(x)L, ..-:- oc)t u_ e.o,b(l)'F o(Ulr- I ' l*. {-, arn L frf .+-, .9 -E .g!-i TEE6-r L_ tF =(UEr- a I .gEEL. i-r x6 AV ,r - ., ra- ts'E o ohE 5F() (,o$i{JTLJ ot5=o-(l)t(t)(U oc; c() .l-, CU (J c)- (}- (o iC' C (U c o*-. (tr +J c(l) E Jt rF' a .s -o(l) e F >. CL (} (, {, of- taJ (, q, cL(0, o'6 -o(Ut-F gL. ir(U -bEo.E,ct iB (tr.=tF. (,C '=(U E?oL,# _ il S'-EEtiEEEFEg-*B* aEE E FE gEE iiE* gEgs F*,Es n . Ei E EE= Ei' iEeE EEEi gs*ggr E EEe-E$EE EgEEE EgEE ilusag = -c.ia.j+brr; --- .+r' *
  • 4. giIiEgig i iEg; ggg U5 gigg l gg- gig t E iEEigggE i ggigE ggg- E gggg g rgg gigg l ga sE s g egE# E*i Eg#E ufiEE;frE;E geE g;gE*EBEE$ rFAl + - p"i --SO-, a
  • 5. r 6. Organization structures: Social organization and legal organization, the .ofi proprietorship, the general partnership, private and public limited companies, their relative advantages and disadvantages' 7. Personnelmanagement: lmportance, principles, methods, motivation, staff requirements theory. g. lnventory controt: Methods-intuitive, systematic wantbook, perpetual inventory, open-to-buy, stock, record card, economic order quality, selection of optimum methods, effect of inventory conkol' g. Purchasing: Formulating effective buying policies,- needs and desires, selecting the sources of supply, determining terms of purchase, receiving, marking and stocking of goods. 10. Quality control overview: lntroduction' general information & significance of quantitative and qualitative analyses in quality control, sampling techniques. Pharmacopoeial tests and specifications, .standardization of pharmaceuticals and formulated products, quality control systems for drugs and pharmaceuticals, causes of poor quality, theo-W and basic concepts of GLP;lSO 9000, lso 9001, lso 17025,TQM and lcH' 11. l]erminology and validation overview: lntroduction, terminology used in the validation of analytical procedures, regulatory basis for process validation. 12. Validation of analytical methods: Strategy and parameters for the validation of methods, verification of standard methods, validation of non- routine methods, analytical validation within the pharmaceutical environment, validation of standard operating procedures (soP)' 13. Retuhtions and laws governing the practices of pharmacy in Bangladesh 6fni enarmacy Ordinance 1076;, role of Pharmacy Community of Bangladesh 14. Policies, sales, regulation and laws concerning to the manufacture, possession, disiribition, sale of drugs and poisons:..The Drug Act 1940 iXXttt of 194b), The Drug Ordinance 1982, The Drug Policy 1982, The Drug iCortrog Ordinance tgSZ (OrOinance No. Vlll of 1982), its amendments, itre ttarcotics (control) Act 1990 , The National drug policy 2005 for regulation of process of registration, manufacture' distribution, sale, import' an"d export of drug in Bingladesh, The Poisons Act 1919 and related amendments 15. Approval process, format and registration of pharmaceuticals in Bangladesh. Page # o8 fr o*{ 5f ildaY &