pharmaceutical manufacturing organization structure

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27 Terms

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research and development, medical, production, marketing, quality assurance, regulatory, engineering, quality control

8 major departments in a manufacturing company

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research and development

department; formulate new products, improve existing products, research on its chemicals, pharmaceuticals, and physiological aspects

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research and development

department; included facilities are a pilot plant, library, and animal house

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production

department; manufacturing of products according to schedule

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production

department; warehousing, storage, and inventory control

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quality assurance

department; ensure the quality of the products by assuring all operations with the manufacture of products meet the required standards of safety and efficacy

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quality assurance

department; assurance of compliance with cGMP and PICS guidelines

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quality assurance

department; quality audit and monitoring

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quality assurance

department; cooperate and coordinate with regulatory agencies

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quality assurance

department; prepares SOP

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quality control

department; test the compliance of raw materials, PMS, and finished products

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quality control

department; conduct sampling

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quality control

department; perform IPQC and even environmental testing

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marketing

department; study the current market trends, consumer behavior, and product status

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marketing

department; plan and execute marketing strategies to boost sales of products

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marketing

department; promotion and advertisement

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regulatory

department; ensure compliance of the company of its products with all pertinent regulations and laws about drugs and marketing

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engineering

department; install, maintain, and repair of equipment

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engineering

department; assures technical safety within the company

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medical

department; perform the physical examination of the personnel

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medical

department; in-charge of performing clinical trials and in publishing house organization paper

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organizational structure

is the bureaucratic set-up of an institution by which its staff, facilities, and other resources are organized in such a manner as to be most effective in accomplishing the purpose for which the organization is established

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specialist

nowadays, a ________ is needed for every individual job because every job today demands specialization

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organizational chart

is a tool to chart the organization structure

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organizational chart

benefit users for their visual communication of information, which is more effective than pure text

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organizational chart

outlines employees' tasks and which manager is responsible for overseeing each employee

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knowledge, skills, capabilities

according to part 2 section 1 (personnel) of AO no. 43 s. 1999, there shall be an adequate number of personnel at all levels having ________, ________, and ____________ relevant to their assigned functions and in good mental and physical health to be able to execute their duties