Curriculum Overview
The Quality Assurance program at SAGAR INSTITUTE OF PHARMACEUTICAL SCIENCES SAGAR MP is structured over eight semesters to provide a comprehensive understanding of pharmaceutical quality management. The curriculum balances theoretical knowledge with practical application, ensuring students are well-prepared for industry roles.
| Semester | Course Code | Course Title | Credit Structure (L-T-P-C) | Pre-requisites |
|---|---|---|---|---|
| 1 | CHM101 | Organic Chemistry I | 3-0-0-3 | - |
| 1 | MAT101 | Mathematics I | 3-0-0-3 | - |
| 1 | BIO101 | Introduction to Biology | 3-0-0-3 | - |
| 1 | CHM102 | Physical Chemistry | 3-0-0-3 | CHM101 |
| 1 | MAT102 | Mathematics II | 3-0-0-3 | MAT101 |
| 1 | BIO102 | Cell Biology | 3-0-0-3 | BIO101 |
| 1 | CHM103 | Inorganic Chemistry | 3-0-0-3 | - |
| 2 | CHM201 | Pharmacognosy | 3-0-0-3 | CHM101, CHM102 |
| 2 | BIO201 | Pharmaceutical Microbiology | 3-0-0-3 | BIO101, BIO102 |
| 2 | CHM202 | Drug Analysis | 3-0-0-3 | CHM101, CHM102 |
| 2 | MAT201 | Statistics | 3-0-0-3 | MAT102 |
| 2 | BIO202 | Biochemistry | 3-0-0-3 | BIO101, BIO102 |
| 2 | CHM203 | Pharmaceutical Chemistry I | 3-0-0-3 | CHM101, CHM102 |
| 3 | CHM301 | Good Manufacturing Practices (GMP) | 3-0-0-3 | - |
| 3 | BIO301 | Pharmacovigilance | 3-0-0-3 | BIO201, BIO202 |
| 3 | CHM302 | Quality Risk Management | 3-0-0-3 | - |
| 3 | MAT301 | Pharmaceutical Statistics | 3-0-0-3 | MAT201 |
| 3 | BIO302 | Pharmaceutical Formulations | 3-0-0-3 | BIO201, BIO202 |
| 3 | CHM303 | Advanced Analytical Techniques | 3-0-0-3 | CHM202, CHM203 |
| 4 | CHM401 | Quality by Design (QbD) | 3-0-0-3 | - |
| 4 | BIO401 | Data Integrity and Compliance | 3-0-0-3 | - |
| 4 | CHM402 | Environmental Monitoring | 3-0-0-3 | - |
| 4 | MAT401 | Advanced Data Analysis | 3-0-0-3 | MAT201, MAT301 |
| 4 | BIO402 | Regulatory Affairs | 3-0-0-3 | - |
| 4 | CHM403 | Stability Testing Methods | 3-0-0-3 | CHM202, CHM303 |
| 5 | CHM501 | Pharmaceutical Quality Control | 3-0-0-3 | - |
| 5 | BIO501 | Continuous Manufacturing | 3-0-0-3 | - |
| 5 | CHM502 | Digital QA Systems | 3-0-0-3 | - |
| 5 | MAT501 | Machine Learning in QA | 3-0-0-3 | MAT201, MAT301 |
| 5 | BIO502 | Validation Strategies | 3-0-0-3 | - |
| 5 | CHM503 | Advanced Chromatography Techniques | 3-0-0-3 | CHM303, CHM403 |
| 6 | CHM601 | Pharmaceutical Impurity Profiling | 3-0-0-3 | - |
| 6 | BIO601 | Signal Detection and Risk Assessment | 3-0-0-3 | BIO401, BIO502 |
| 6 | CHM602 | Process Optimization | 3-0-0-3 | - |
| 6 | MAT601 | Statistical Process Control | 3-0-0-3 | MAT201, MAT301 |
| 6 | BIO602 | Clinical Trial Safety Monitoring | 3-0-0-3 | BIO501 |
| 6 | CHM603 | Pharmaceutical Stability Studies | 3-0-0-3 | CHM403, CHM503 |
| 7 | CHM701 | Mini Project I | 2-0-0-2 | - |
| 7 | BIO701 | Mini Project II | 2-0-0-2 | - |
| 7 | CHM702 | Research Methodology | 3-0-0-3 | - |
| 7 | MAT701 | Thesis Preparation | 3-0-0-3 | - |
| 7 | BIO702 | Advanced Research Topics | 3-0-0-3 | - |
| 7 | CHM703 | Capstone Project | 4-0-0-4 | - |
| 8 | CHM801 | Final Year Thesis | 6-0-0-6 | - |
| 8 | BIO801 | Internship | 4-0-0-4 | - |
| 8 | CHM802 | Industry Exposure Session | 2-0-0-2 | - |
| 8 | MAT801 | Final Presentation | 2-0-0-2 | - |
| 8 | BIO802 | Capstone Defense | 2-0-0-2 | - |
| 8 | CHM803 | Final Project Review | 2-0-0-2 | - |
Advanced Departmental Elective Courses:
- Advanced Chromatography Techniques: This course covers advanced methods in chromatographic separation and analysis, including HPLC, GC, and CE. Students learn about column selection, method development, and troubleshooting techniques.
- Pharmaceutical Impurity Profiling: Focuses on identifying and quantifying impurities in pharmaceutical products using various analytical techniques. Emphasis is placed on regulatory compliance and quality assurance.
- Signal Detection and Risk Assessment: Explores methodologies for detecting signals from adverse events and assessing associated risks. Students gain hands-on experience with risk assessment tools and software.
- Digital QA Systems: Introduces digital solutions for managing quality data, including electronic records, audit trails, and automated systems. Students learn about integration challenges and best practices.
- Process Optimization: Examines strategies for optimizing pharmaceutical manufacturing processes to improve efficiency and reduce variability. Topics include design of experiments and statistical process control.
- Pharmaceutical Stability Studies: Covers methods for evaluating the stability of drug substances and products under various conditions. Students learn about degradation pathways, shelf-life determination, and stability testing protocols.
- Machine Learning in QA: Applies machine learning algorithms to pharmaceutical data analysis, including predictive modeling, classification, and clustering techniques. Practical applications include quality prediction and anomaly detection.
- Validation Strategies: Provides an overview of validation principles and practices in pharmaceutical manufacturing. Students learn about process validation, analytical method validation, and equipment qualification.
- Pharmacovigilance Guidelines: Focuses on global pharmacovigilance regulations and guidelines. Students explore adverse event reporting, signal detection, and safety monitoring systems.
- Statistical Process Control: Teaches statistical methods for controlling manufacturing processes and ensuring consistent product quality. Includes topics like control charts, process capability analysis, and Six Sigma principles.
- Data Management in QA: Covers data integrity requirements, electronic data systems, and compliance with regulatory standards. Students learn about data handling, storage, and retrieval procedures.
- Compliance Auditing: Introduces auditing techniques used in quality assurance environments. Includes internal audits, external inspections, and corrective action processes.
- Environmental Monitoring: Focuses on monitoring environmental conditions in manufacturing facilities to ensure compliance with GMP standards. Topics include air quality testing, microbial monitoring, and cleanroom operations.
- Quality by Design (QbD): Explores the principles of QbD and its application in pharmaceutical development. Students learn about risk assessment, design space establishment, and control strategy development.
- Pharmaceutical Formulations: Examines formulation strategies for various dosage forms, including tablets, capsules, and injectables. Topics include excipient selection, formulation optimization, and stability studies.
Project-Based Learning Philosophy:
The department places a strong emphasis on project-based learning to enhance practical understanding and professional readiness. Students are encouraged to engage in mini-projects during their second year and a final-year thesis or capstone project that integrates all learned concepts. The mini-projects allow students to apply theoretical knowledge in real-world scenarios, while the final project provides an opportunity for in-depth research and innovation.
Mini-projects are structured with clear objectives, timelines, and deliverables. Students work under faculty mentorship and collaborate with peers to develop solutions to industry challenges. The projects are evaluated based on technical merit, creativity, presentation quality, and teamwork skills.
The final-year thesis/capstone project is a significant component of the program, where students conduct independent research or solve complex problems in QA. The process includes proposal development, literature review, experimental design, data analysis, and documentation. Faculty mentors guide students through each phase, ensuring high-quality outcomes that meet industry standards.
Project selection involves discussions between students and faculty members to align interests with available resources and expertise. Students can propose topics related to current industry trends or areas of personal interest, subject to approval by the department head.