Syllabus for registration xam
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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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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
&](https://image.slidesharecdn.com/syllabusforregistrationxam-140424065606-phpapp01/85/Syllabus-for-registration-xam-5-320.jpg)
Syllabus for registration xam
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