Quality control is the day- to-day assessment of all compounding operations. This includes receipt of raw materials, preparation, storage, distribution, patient administration, and analytic testing of the finished product .

Aspect of management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are:

— an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources;

— systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed “quality assurance”. Within an organization, quality assurance serves as a management tool

READINGS

1. Ahuja S, Scypinski S. Handbook of modern pharmaceutical analysis. 2nd Ed. Academic Press; 2010.
2. British Pharmacopoeia
3. United State Pharmacopoeia
4. SHAYNE COX GAD, PH.D., D.A.B.T. PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality Gad Consulting Services Cary, North Carolina
5. Beckett AH, Stennlake JB. Practical Pharmaceutical Chemistry. 4th Ed. The Alton Press; 2001.
6.  Lund W. The Pharmaceutical Codex: Principles and practice of pharmaceutics. 16th Ed. Co CBS Publishers; 2009.
7. Mehta DK. British National Formulary (BNF). 54th Ed. Pharmaceutical Press; 2016.

CONTENTS

Pharmaceutical Quality Management

1. INTRODUCTION: Basic concepts and introduction of pharmaceutical industry in relevance to quality control departments, Testing, Quality Management System, Quality Assurance, Good Manufacturing Practices and Current Good Manufacturing Practices. General understanding of good laboratory practices and validation.
2.  QUALITY CONTROL OF SOLID DOSAGE FORMS (Conventional and modified release dosage forms):

1. Physical tests: Hardness, Thickness, Diameter, Friability, Disintegration, Weight Variation.
2. Chemical tests: Content uniformity, Assay of active Ingredient.

1. QUALITY CONTROL OF SYRUPS, ELIXIRS, AND DISPERSE SYSTEM: Viscosity, its determination and application in the Quality Control of Pharmaceuticals, Weight per ml and Assay of active Ingredient.
2. QUALITY CONTROL OF SUPPOSITORIES: Dissolution test, Uniformity of weight, Assay of active Ingredient, Liquefaction time test and Breaking test.
3. QUALITY CONTROL OF STERILE PRODUCTS (PARENTERALS): Sterility Test and Sterile section management, Leaker’s test, Clarity test, Pyrogen test for Parenteral and other sterile preparations, Assay for active Ingredient.
4. STANDARDIZATION OF PHARMACEUTICALS: An understanding of quality assurance system adopted in pharmaceutical industry. Good Manufacturing Practices and Current Good Manufacturing Practices.

COURSE SCHEDULE

ASSESSMENT CRITERIA

Sessional:  20

1. Assignement: 10
2. Presentation:  10

Midterm exam: 30

Final exam: 50

RULES AND REGULATIONS