JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

The students shall learn the theory of unit operations, machinery, materials of

constructions, qualification of equipments and its utility. The students shall also understand about the objectives and principles of GMP, TQM and effluent analysis and specifications. They also understand the regulatory basis for the validation of analytical methods related to solids, sterile and liquid dosage forms

Course Outcome

The students will explain the machinery involved in milling, mixing, filtration, drying

and packing material constructions used in the production of pharmaceutical materials. They also learn salient feature1s of GMP, TQM applicable in industry. They also understand the effluent treatments and prevent the pollution. They also should evaluate the validation of analytical methods and processes

UNIT - I

Pharmaceutical unit operations: A detailed study involving machinery and theory of Pharmaceutical unit operations like milling, mixing, filtration, granulation, drying and blending.

UNIT - II

• a. Materials of construction of pharmaceutical equipment and packaging materials: Study of the principles, production techniques in the large scale production of tablets, capsules, suspensions, liquid pharmaceuticals, ophthalmic products and sterile products.
• b. Qualification of equipment (IQ, OQ, PQ)

UNIT - III

Production management: Production organization, objectives and policies of good manufacturing practices, layout of buildings, services, equipments and their maintenance, material management, handling and transportation, inventory management and control, production and planning control, Sales forecasting, budget and cost control, industrial and personal relationship. Total Quality Management (TQM)

UNIT - IV

Effluent Testing and Treatment: Effluent analysis, specifications and preventive measures water of pollution, solid pollution, air pollution and sound pollution.

UNIT - V

Validation: Regulatory basis, validation process for solid dosage forms, sterile products, and liquid dosage forms.

TEXT BOOKS:

• 1. The Theory and Practice of industrial Pharmacy by Leon Lachman, Herbert A. Lieberman.
• 2. Good Manufacturing Practice for Pharmaceuticals by Sidney H. willig.
• 3. Pharmaceutical Process validation by Robert A. Nash, Alfred H. Wachter.
• 4. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes.
• 5. Pharmaceutical production management, C.V.S. Subrahmanyam, Vallabh Prakash.
• 6. Industrial Pharmacy: A Comprehensive Approach, D K Tripathi, Pharmamed Press. R22M.PHARM PHARMACEUTICS/PHARMACEUTICAL TECH. JNTUH

REFERENCE BOOKS:

• 1. Unit operations of Chemical Engineering by Warren L. McCabe, Julian C. Smith, Peter Harriott.
• 2. Remington’s Science and Practice of Pharmacy by A. Gennaro.
• 3. Bentley’s Text book of Pharmaceutics by EA Rawlins.
• 4. CGMP, H.P.P. Sharma R22M.PHARM PHARMACEUTICS/PHARMACEUTICAL TECH. JNTUH M.Pharm I Year II Sem (Pharmaceutics/Pharmaceutical Technology)