Overview: This Pharmaceutical Quality Assurance course provides students with an understanding of key concepts in the pharmaceutical industry using a problem-based approach in a series of seminars and field and lab practical, which enable the students to apply the concepts in the quality management system, good manufacturing practice, documentation, and data integrity.

(a) Rationale: The main reason for offering this program are:

• To create honest, skilled and competent personals in Quality Assurance with focused on requirement for pharmaceutical industry at national and international level.
• Provide in depth learning in regulatory requirements, documentation, quality management systems, validation of equipment, which is very much need for the pharmaceutical industries at local, regional and global level.

(b) Goals and Objectives:

This course is designed to provide foundation knowledge of quality management system, documentation etc. national as well as at global level. Upon completion of the course, it is expected that the students will be able to (know, do and appreciate)

• Concepts of quality control and quality assurance and its implementation
• Regulatory guidance’s and guidelines like ICH, WHO and other relevant documents related to Quality Management system.
• Good Laboratory Practices, SOPs, handling of deviation
• Good Documentation Practices
• Concepts of validation and its implementation
• Validation of process, equipment and products.
• Calibration of Glassware’s, & Instruments.

Structure of Program

A. This program is intended for professionals working in industries, researchers and students from wide range of backgrounds who aim to develop their knowledge, skill, and competence pertaining to quality management system in pharmaceutical industries.

The course in designed to provide fundamental and practical skills to the persons working in the pharmaceutical industries to ensure that each prepared medicine reaching a patient is safe, effective and of acceptable quality. This comprehensive program includes both technical and managerial activities of the quality management systems of industries which include evaluation of product documentation, data integrity, validation and qualification of equipment, performance or reviewing quality control lab tests, manufacturing process and monitoring the performance of each activity in the industry. The managerial activities include selection of reliable suppliers, preparing contract terms, monitoring their performance and performing inspection procedures throughout the distribution network.

The building of quality culture in the companies provides the information on role and responsibilities personals, basic elements of quality management like an appropriate infrastructure or 'quality system', encompassing the organizational structure, procedures, processes and resources and systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality.

Overall in an organization, quality assurance serves as a management tool.

B. Instructional Design

JSS Academy of Higher Education and Research, Mysuru follows a modern ICT enabled approach for instruction. The methodology of instruction in JSS Academy of Higher Education and Research is different from that of the conventional /regular programs. Our system is learner-oriented and the learner is an active participant in the teaching-learning process. Most of the instructions are imparted through online and distance mode. Academic delivery systems of JSS Academy of Higher Education and Research are:

a) Curriculum design:

The E-Learning Material shall have the four-quadrant approach; as per UGC Regulations, 2016 taking into consideration the following, namely:-

• Quadrant-I is e-Tutorial; which shall contain: Video and Audio Content in an organized form, Animation, Simulations, Video Demonstrations, handouts, etc,.
• Quadrant-II is e-Content; which shall contain; self-instructional material, e-Books, illustrations, case studies, presentations etc, and also contain Web Resources such as further references, Related Links, Open-source Content on Internet, Video, Case Studies, books including e-books, research papers and journals, Anecdotal information, Historical development of the subject, Articles, etc.
• Quadrant-III is the Discussion forum for raising of doubts and clarifying them on a near real time basis by the Course Coordinator or his team.
• Quadrant-IV is Assessment, which shall contain; Problems and Solutions, which could be in the form of Multiple-Choice Questions, fill in the blanks, Matching Questions, Short Answer Questions, Long Answer Questions, Quizzes, Assignments and solutions, Discussion forum topics and setting up the FAQs, Clarifications on general misconceptions.

Each unit will be projected as modules and the content for each module will be put under the four quadrants as mentioned above. Each module accounts for 24 hours of learning. One credit will be awarded for 30 hours of learning including participating in discussion forums and other interactions, working on assignments and activities designated for the course etc. Totally at the end of the Diploma program 400 credits will be awarded. Given below is an example of core paper, divided as per the online education guidelines.

Paper I - Principles of Quality Assurance

• Unit -I: Introduction to Quality
• Unit -II: Pharmaceutical Quality management
• Unit -III: Quality Control.
• Unit -IV: Documentation.
• Unit -V: Quality in Pharmaceutical development and Stability studies

Paper II - Pharmaceutical Validation

• Unit -I: Introduction
• Unit -II: Qualification & Validation of Facility and Utility Systems
• Unit -III: Process Validation
• Unit -IV: Validation of Biotechnological Process, Q5A to 5E
• Unit -V: Validation of Analytical Methods and Packaging Validation