Elective: Pharmaceuticals Management (Part -2)

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Elective: Pharmaceuticals Management (Part -2)

Attend any 4 questions.  Each question carries 25 marks

(Each answer should be of minimum 2 pages / of 300 words)

1.Explain the manufacturing technologies for Pharmaceutical Products.

Answer : Efficient handling and processing of particulates is critical to profitable manufacture of pharmaceutical products. Over 75 percent of all pharmaceutical products are in the solid dosage form and particulates are involved in almost every stage of the manufacturing process. A recent US-FDA report on the pharmaceutical industry estimated that worldwide cost savings from manufacturing improvements could be as high as US$ 90 billion per year. Regulatory constraints have traditionally encouraged an empirical and incremental approach to process improvement. Quality assurance through inspection rather than through design has previously been the norm. However, this is now changing and there is a growing awareness of the need for improvement in the science and engineering of drug development.

The introduction of manufacturing methods based on product performance specifications, rather than solely traditional practices, is increasing along with advanced computer modelling and measurement techniques to facilitate a better understanding

2.Write an essay on Indian Pharmaceutical Industry.

Answer : Indian pharmaceutical industry is divided into two categories as bulk drugs and formulations by its physical properties and marketing point of view ethical, generic and OTC and line of treatment the industry is further divided as Allopathic, Ayurveda, Homeopathy, Unani etc.

In our context Allopathic is more relevant as it occupies more than 80% of market share. Furthermore Indian pharmaceutical sector has successfully crossed all phases from monopolistic phase to multi-brand phase to emerging market phase and now commoditisation phase stepping ahead to give a new shape for pharmaceutical marketing.

It is observed that Infrastructure base of Indian pharmaceutical industry comprises of more than 3.9 lakhs allopathic practicing doctors with 15 thousands hospitals and 1.6 lakhs pri­mary health centres and with a highest doctor chemist ratio of 2:

3.What are the characteristics of MBO? Discuss.

Answer : 1. Goal Orientation:

MBO focuses on the determination of unit and individual goals in line with the organizational goals. These goals define responsibilities of different parts of the organisation and help to integrate the organisation with its parts and with its environment.

MBO seeks to balance and blend the long term objectives (profit, growth and survival of the firm with the personal objectives of key executives. It requires that all corporate, departmental and personal goals will be clearly defined and integrated.

2. Participation:

4.What are the basic principles of Organization? Explain.

Answer :

5.Explain the specific requirements for manufacture of sterile products.

Answer : Principle

The manufacture of sterile products is subject to special requirements in order to minimize  risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test.

General

6.Write an essay on Pharmaceutical Export.

Answer :

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 25 x 4=100 marks