M .

Pharm - Sem II
PHARMACEUTICAL PRODUCTION MANAGEMENT & TECHNOLOGY (PH887) (Theory) PHARMACEUTICAL FORMULATIONS & ADVANCED TECHNOLOGY (PH 881.06) (Theory & Practical)
1/4/2013 RPCP, CHARUSAT 1

Syllabus
1. (A) Manufacturing, manufacturing flowcharts, in process-quality control tests for following sterile dosage forms: Ointment Suspension and Emulsion Dry powder Solution(Small Volume & large Volume)

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RPCP, CHARUSAT

 2. (A) Manufacturing, manufacturing flowcharts, in process-quality control tests for following Non-Sterile solid dosage forms: Tablets (compressed & coated) Capsules (Hard & Soft)

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RPCP, CHARUSAT

 Formulation, manufacturing, manufacturing flowcharts, in process-quality control tests, finished product quality control tests, Scale Up and SUPAC guidelines for following dosage forms: Tablets (compressed & coated) Capsules (Hard & Soft) Semisolids (ointment & creams) Solution Suspension and Emulsion Sterile dosage forms
1/4/2013 RPCP, CHARUSAT 4

Main aspects to study

Formulation and manufacturing Manufacturing flowcharts , In process-quality control tests and finished product quality control tests Scale Up and SUPAC guidelines

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RPCP, CHARUSAT

Formulation and manufacturing

Date/day

Manufacturing flowcharts , In processquality control tests and finished product quality control tests Tablets (compressed & coated) Capsules (Hard & Soft) Semisolids (ointment & creams) Sterile dosage forms Suspension and Emulsion Solution Dry powder

Date/ day

Scale Up and SUPAC guidelines

Date/d ay

Tablets (compressed & coated) Capsules (Hard & Soft) Semisolids (ointment & creams) Sterile dosage forms Suspension and Emulsion Solution Dry powder Non - Sterile dosage forms Suspension and Emulsion Solution Dry powder
1/4/2013

4/1

11/1

Tablets (compressed & coated)

18/1

25/1 15/2

1/2 22/2 1/3 22/3

Capsules (Hard & Soft) Semisolids (ointment & creams)

8/2 8/3

15/3

Sterile dosage forms Suspension and Emulsion Solution Dry powder

29/3

Non - Sterile dosage forms Suspension and Emulsion Solution Dry powder
RPCP, CHARUSAT

Non - Sterile dosage forms Suspension and Emulsion Solution Dry powder
6

Recommended Study materials: 1. Good manufacturing practices for Pharmaceuticals: A plan for total quality control, Second edition; By Sidney H. Willig. 2. Applied production and operations management; By Evans, Anderson, Sweeney and Williams. 3. A Text of Pharmacy management, HW Tomski, Kogan Page ltd. London 4. ISO 9000 and 14000 Series 5. Pharmaceutical Production and management by C.V.S. Subrahmanyam, Vallabh Prakashan. 6. Pilot plants model and scale-up methods, Johnstone and Thring. 7. Chemical Engineering Plant Design, Vibrant. 8. Drug and Cosmetic Act 1940 & Rules 9. Pharmaceutical Production Facilities, design and applications, by G.C. Cole, Taylor and Francis. 10. Pharmaceutical Project Management, T.Kennedy, Vol 86, Marcel Dekker, NY 11. Theory & Practice of Industrial Pharmacy, L. Lachman, Varghese Publication, Bombay. 12. Pharmaceutical production facilities: design and applications. Cole,Graham 13. Safety assessment for pharmaceuticals, Gad,Shayne 14. From Bench to Pilot plant:Process research in the pharmaceutical industries, Mehdi Nafissi,John a Ragan,Keith M Devries 15. Pharmaceutical Process Scale-up, Michael Levin 16. Pharmaceutical Process engineering, David Ganderton & Anthony Hickey
1/4/2013 RPCP, CHARUSAT