syllabus for registration

8/12/2019 Syllabus for Registration

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6. Organization structures: Social organization and legal organization, the.ofi proprietorship, the general partnership, private and public limitedcompanies, their relative advantages and disadvantages'

7. Personnelmanagement: lmportance, principles, methods, motivation, staffrequirements theory.g. lnventory controt: Methods-intuitive, systematic wantbook, perpetualinventory, open-to-buy, stock, record card, economic order

quality, selectionof 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 & significanceof quantitative and qualitative analyses in quality control, samplingtechniques. Pharmacopoeial tests and specifications, .standardization ofpharmaceuticals and formulated products, quality control systems for drugsand pharmaceuticals, causes of poor quality, theo-W and basic concepts ofGLP;lSO 9000, lso 9001, lso 17025,TQM and lcH'

11. l]erminology and validation overview: lntroduction, terminology used inthe validation of analytical procedures, regulatory basis for processvalidation.

12. Validation of analytical methods: Strategy and parameters for thevalidation of methods, verification of standard methods, validation of non-routine methods, analytical validation within the pharmaceuticalenvironment, validation of standard operating procedures (soP)'

13. Retuhtions and laws governing the practices of pharmacy in Bangladesh6fni enarmacy Ordinance 1076;, role of Pharmacy Community ofBangladesh14. 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 DrugiCortrog Ordinance tgSZ (OrOinance No. Vlll of 1982), its amendments,itre ttarcotics (control) Act 1990 , The National drug policy 2005 forregulation of process of registration, manufacture' distribution, sale, import'an"d export of drug in Bingladesh, The Poisons Act 1919 and relatedamendments

15. Approval process, format and registration of pharmaceuticals inBangladesh.

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