Pharmaceutical quality control ( 2 hr lecture+ 2 hr practical)

Description

This course builds on the previously discussed concepts of formulation, pharmaceutical technology, and pharmaceutical analysis and trains the students to develop and validate sound procedures and methods for the evaluation of the physical and chemical properties of pharmaceutical products. The content of the course is designed to familiarize undergraduates with the QC, GLP and related regulatory protocols; the ability to design analytical procedures and validate them in order to understand, compile, defend and interpret Analytical Profiles and Monographs; and the ability to conduct a full examination of a named material to confirm identity and compliance with a pharmacopoeia monograph. The course also includes microbiological QC of sterile and non-sterile pharmaceutical products. The practical module is designed to familiarize undergraduates with all QC/QA activities. The proper resources for the development of compliance standards will be discussed. Students will be provided with an opportunity to test their methods and compare their validity to compendial or commonly adopted procedures in the pilot plant.

Program

Bachelor of Pharmacy-B Pharm

Objectives

• By the end of the course students will be able to: a. Knowledge and Understanding a.1. Describe different methods for QC assessment of pharmaceuticals. a.2. Outline the general procedures for validation of the analysis method. a.3. Explain the basic concepts of good lap procedure (GLP), quality control (QC) and quality assurance (QA). b. Intellectual Skills b.1. Apply pharmacopeia methods of stability and stability testing of the drugs. b.2. Organize data and documentation coupled with a working knowledge of relevant statistical methods. b.3. Evaluate QC and validation methods. c. Professional and Practical Skills c.1. Apply standard laboratory skills and techniques required for quality control analysis of different market drugs. c.2. Handle chemicals and carry out standard laboratory analytical procedures safely. d. General and Transferable Skills d.1. Manage time properly. d.2. Adopt self-learning. d.3. Evaluate the results obtained from the practical work. d.4. Develop decision making skills to deal with different problems.