INTRODUCTION & OBJECTIVES

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.

LEARNING OUTCOMES

The student will 

• describe quality management and its importance within the firm
• earn how to use effective tools and techniques for quality design and control
• learn how to use and apply quality improvement tools and techniques
• describe, explain, and apply statistical process control and tools
• learn safe and effective handling and storage of vaccines
• explain statistical quality control

READINGS:

1. Principles and Methods of Bioassay (Prof. Ramesh K. Goyal)
2. BIOLOGICAL ASSAYS : (81) Antibiotic Microbial Assay(USP 37 NF 27),
3. Insulin Bioassay(USP 37 NF 27), (581) Vitamin D assay ((USP 37 NF 27)
4. Bioassay techniques for drug development(Atta-ur-RahmanandM.IqbalChoudharyand William J.Thomsonharwood academic publishers)
5. Guidelines for Production and Quality Control of Vaccine

DESCRIPTION OF SYSTEM OF EVALUATION (Exam, assignments etc.)

Sessional:    20   Presentation: 10       Surprise Test: 10

Mid Term:     30   

Final exam:  50

CLASS TIMINGS:

Every Monday:

Regular: 08:00AM

Self Support: 11:30AM