Fourth Professional, First Semester, Pharmaceutics

PHARMACEUTICS-XI (Pharmaceutical Quality Management-I)
(Theory)


Cr. Hr. 03

1. SCOPE

(a) An understanding of the testing, quality control programme and methods adopted in a pharmaceutical industry, dosage form control, process control, testing program and methods, physical, chemical and biological tests and specifications, statitical quality control.

(b) General understanding of Total Quality Assurance and measures to adopt Quality Assurance

2. QUALITY CONTROL OF SOLID DOSAGE FORMS:

(a) Physical tests: Hardness, Thickness and Diameter, Friability, Disintegration, Weight Variation.

(b) Chemical tests: Content uniformity, Assay of active ingredients and dissolution tests of Powders, Granules, Tablets and Capsules.

3. QUALITY CONTROL OF SYRUPS AND ELIXIRS:

Viscosity, its determiantion and application in the Quality Control of Pharmaceuticals, Weight per ml and Assay of active ingredients.

4. EVALUATION OF SUSTAINED ACTION PRODUCTS (TABLETS & CAPSULES):

Stability of viability rate during storage and In-vitro & In-vivo evaluation of sustaining action.

5. QUALITY CONTROL OF SUPPOSITORIES Disintegration test, Uniformity of weight, Assay of active ingredients, Liqefaction time test and Breaking test.

6. QUALITY CONTROL OF STERILE PRODUCTS (PARENTERALS) Leaker’s test, Clarity test, Pyrogen test for parenterals and other sterile preparations and Assay for active ingredients.

PHARMACEUTICS-XI (Pharmaceutical Quality Management-I)
(Laboratory)

Cr. Hr. 01

NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g. Assay of various spirits, tinctures, extracts, syrups and elixirs, Assay of Ointments and suppositories, Assay of tablets and capsules, Test for alkalinity of glass, Determiantion of alcohol contents in the Pharmaceutical preparations and Pyrogen test.

Recommended Books

1. A H Beckett and J B Stennlake, Practical Pharmaceutical Chemistry, Part-I and II, The Alton Press, London.
2. M Knevel and F E Digangi, Jenkin’s Quantitative Pharmaceutical Chemistry, McGraw-Hill Book Company, New York.
3. K A Connors, A Text Book of Pharmaceutical Analysis, John — Wiley and Sons, New York.
4. Braithwaite and F J Smith, Chromatographic Methods, Chapman and Hall, London.
5. G D Christian, Analytical Chemistry, John Wiley and Sons, New York.
6. Karamt A Javaid, Pharmaceutical Quality Assurance in Class, Industry and Market, Aziz Publishers, Lahore-Pakistan (1993).
7. Gil Bismuth and Shosh Neumann, Cleaning Validation, A practical approach. CRC Press, LLC, USA, 2003.
8. J T Carstersen and C T Rhodes, Drug Stability: Principles and Practices, 3rd Ed. (revised and expanded), Mercel Dekker, New York. 2000.
9. Sydney H Willig, Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker Publishing.
10. Bryant R, The pharmaceutical Quality Control Hand Book, Aster Publishing Corporation, Eugene, 1989.
11. Braun R E, Introduction to Instrumental Analysis, McGraw-Hill Book Co, NY, 1987.