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M . Pharm - Sem II

PHARMACEUTICAL PRODUCTION

MANAGEMENT & TECHNOLOGY

(PH887)

(Theory)

PHARMACEUTICAL FORMULATIONS

& ADVANCED TECHNOLOGY

(PH 881.06)

(Theory & Practical)

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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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Formulation, manufacturing, manufacturingflowcharts, in process-quality control tests,

finished product quality control tests, Scale Upand SUPAC guidelines for following dosage

forms:

Tablets (compressed & coated)

Capsules (Hard & Soft)

Semisolids (ointment & creams)

Solution

Suspension and Emulsion

Sterile dosage forms

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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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Formulation

and

manufacturing

Date/day Manufacturing

flowcharts , In process-

quality control tests and

finished product quality

control tests

Date/

day

Scale Up and SUPAC guidelines Date/d

ay

Tablets(compressed &

coated)

4/1 Tablets (compressed &coated)

11/1 Tablets (compressed & coated) 18/1

Capsules (Hard

& Soft)

25/1 Capsules (Hard & Soft) 1/2 Capsules (Hard & Soft) 8/2

Semisolids

(ointment &creams)

15/2 Semisolids (ointment &

creams)

22/2

1/3

Semisolids (ointment & creams) 8/3

Sterile dosage

forms

Suspension and

Emulsion

Solution

Dry powder

15/3 Sterile dosage forms

Suspension and

Emulsion

Solution

Dry powder

22/3 Sterile dosage forms

Suspension and Emulsion

Solution

Dry powder

29/3

Non - Sterile

dosage forms

Suspension and

Emulsion

Solution

Dry powder

Non - Sterile dosage

forms

Suspension and

Emulsion

Solution

Dry powder

Non - Sterile dosage forms

Suspension and Emulsion

Solution

Dry powder

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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 Hickey1/4/2013 7RPCP, CHARUSAT