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M-PHARM in Pharmaceutical Quality Assurance at Sri Ramachandra Institute of Higher Education and Research
Chennai, Tamil Nadu
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About the Specialization
What is Pharmaceutical Quality Assurance at Sri Ramachandra Institute of Higher Education and Research Chennai?
This Pharmaceutical Quality Assurance program at Sri Ramachandra Institute of Higher Education and Research focuses on equipping professionals with in-depth knowledge of quality management systems, regulatory compliance, and advanced analytical techniques crucial for the pharmaceutical industry. The curriculum is meticulously designed to meet the stringent quality demands of drug manufacturing, ensuring safety, efficacy, and global standards are upheld in the Indian pharmaceutical landscape.
Who Should Apply?
This program is ideal for Bachelor of Pharmacy graduates aspiring to specialize in quality control, quality assurance, and regulatory affairs within the pharmaceutical sector. It also caters to industry professionals seeking to enhance their expertise in pharmaceutical manufacturing, validation, and auditing practices to take on leadership roles. Prior academic excellence in pharmacy is a key prerequisite.
Why Choose This Course?
Graduates of this program can expect promising career paths in leading Indian pharmaceutical companies, contract research organizations, and regulatory bodies as Quality Assurance Managers, Quality Control Analysts, Regulatory Affairs Specialists, and Validation Experts. Starting salaries typically range from INR 3-6 lakhs per annum for freshers, with significant growth trajectories for experienced professionals, aligning with the industry''''s focus on quality.
Student Success Practices
Foundation Stage
Master Core QA Principles- (Semester 1-2)
Focus intensely on understanding fundamental concepts like GMP, GLP, ICH guidelines, and Quality Management Systems. Regularly review and apply these principles through case studies and theoretical problems, ensuring strong conceptual clarity.
Tools & Resources
Official ICH guidelines documents, WHO GMP guidelines, Online QA forums, Textbooks on Pharmaceutical Quality Assurance
Career Connection
A strong foundation is critical for all QA/QC roles and helps in clearing entry-level technical interviews for positions like Quality Control Analyst or Junior QA Executive.
Develop Laboratory Proficiency- (Semester 1-2)
Actively participate in all practical sessions, striving for precision and accuracy in analytical tests, calibration, and documentation. Maintain meticulous lab notebooks and understand the underlying principles of each experiment and instrument.
Tools & Resources
Lab manuals, Instrument operation guides, Peer group discussions, Online tutorials for advanced analytical techniques (e.g., HPLC, GC operation)
Career Connection
Hands-on experience in quality control testing and instrument handling is invaluable for roles in QC labs and validation teams, showcasing practical skill sets to potential employers.
Engage with Regulatory Frameworks- (Semester 1-2)
Begin to familiarize yourself with major Indian (CDSCO) and international (USFDA, EMA) regulatory bodies and their guidelines. Participate in discussions on drug laws, intellectual property rights, and regulatory filing processes.
Tools & Resources
CDSCO website, FDA website, Regulatory affairs journals, Webinars on pharmaceutical regulations, Legal resources for IPR
Career Connection
Early exposure to regulatory aspects prepares students for roles in Regulatory Affairs and ensures compliance understanding, which is highly valued in quality assurance functions across the pharmaceutical industry.
Intermediate Stage
Deep Dive into Validation and Auditing- (Semester 3)
Focus on understanding various types of validation (process, analytical method, cleaning, software) and equipment qualification. Actively participate in discussions and case studies related to conducting internal and external audits, identifying non-conformances, and implementing corrective actions.
Tools & Resources
ICH Q7, Q9, Q10 guidelines, ISO 9000 series standards, Industry-specific audit checklists, Quality management system software demonstrations
Career Connection
Expertise in validation and auditing is highly sought after for specialized roles as Validation Specialists, Quality Auditors, and Compliance Managers in pharmaceutical manufacturing.
Initiate and Progress Project Work (Part I)- (Semester 3)
Select a relevant research topic, conduct a comprehensive literature review, formulate a clear research hypothesis, and design a robust experimental plan. Begin preliminary experiments, data collection, and maintain detailed project documentation, seeking regular faculty guidance.
Tools & Resources
Academic databases (Scopus, Web of Science), Reference management software (Mendeley, Zotero), Statistical analysis tools (e.g., GraphPad Prism, basic R/Python)
Career Connection
This phase hones critical thinking, problem-solving, and research methodology skills, which are essential for R&D, product development, and advanced QA roles. It also forms the basis for your thesis defense.
Network and Professional Development- (Semester 3)
Actively attend pharmaceutical conferences, workshops, and industry seminars. Join student chapters of professional bodies like the Indian Pharmaceutical Association (IPA) or ISPE to network with industry experts, potential mentors, and peers, and stay updated on industry trends.
Tools & Resources
LinkedIn for professional networking, Industry event calendars, University career services, Professional body websites
Career Connection
Building a strong professional network significantly improves internship and job prospects, provides insights into career paths, and fosters long-term professional relationships.
Advanced Stage
Finalize and Defend Project Work (Part II)- (Semester 4)
Complete experimental work, perform rigorous data analysis, write a comprehensive thesis, and prepare for the viva voce examination. Focus on clear communication of research findings, methodology, and their implications.
Tools & Resources
Thesis writing guides, Presentation software (PowerPoint/Google Slides), Mock viva sessions with faculty and peers
Career Connection
A strong project defense demonstrates advanced research skills, subject mastery, and communication abilities, which are crucial for high-level QA/QC, R&D, and regulatory roles.
Intensive Placement Preparation- (Semester 4)
Actively engage with the university''''s placement cell. Prepare a tailored resume highlighting QA/QC skills, internships, and project work. Practice technical and HR interviews, focusing on case studies relevant to quality management and regulatory compliance.
Tools & Resources
University placement portal, Resume builders, Mock interview platforms, Industry-specific interview guides
Career Connection
This focused preparation directly leads to securing desirable placements in top pharmaceutical companies as Quality Assurance Executives, Regulatory Specialists, or Process Validation Engineers.
Continuous Learning and Certification- (Semester 4)
Identify and pursue relevant professional certifications (e.g., Certified Quality Auditor, Lean Six Sigma Green Belt for Pharma) to augment your academic qualifications. Stay updated with emerging technologies and global regulatory changes.
Tools & Resources
Online certification platforms (ASQ, Udemy, Coursera for specialized courses), Pharmaceutical industry news portals, Regulatory authority newsletters
Career Connection
Continuous learning and certifications demonstrate commitment to the field and can significantly enhance employability, career progression, and salary potential in a competitive industry.
Program Structure and Curriculum
Eligibility:
- B.Pharm. Degree from a recognized University with a minimum of 55% aggregate marks. (as per 2023-24 regulations)
Duration: 2 years / 4 semesters
Credits: 128 Credits
Assessment: Internal: 25%, External: 75%
Semester-wise Curriculum Table
Semester 1
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPQA 101T | Quality Management Systems | Core Theory | 4 | Introduction to Quality Management, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ICH Guidelines (Q7, Q8, Q9, Q10), Quality Documentation, ISO Series (ISO 9000, 14000) |
| MPQA 102T | Concepts of Pharmaceutical Quality Assurance | Core Theory | 4 | Basics of Quality Assurance, Total Quality Management (TQM), Quality Audits, Validation Principles, Calibration and Qualification, Change Control and Deviations |
| MPQA 103T | Product Development and Quality Management | Core Theory | 4 | Stages of Product Development, Quality by Design (QbD), Process Analytical Technology (PAT), cGMP for Sterile Products, Quality of Packaging Materials, Stability Studies |
| MPQA 104T | Pharmaceutical Manufacturing Technology | Core Theory | 4 | Unit Operations in Manufacturing, Material Handling and Storage, Facility Design and Layout, Environmental Control and HVAC, Water for Pharmaceutical Use Systems, Aseptic Processing |
| MPQA 105P | Pharmaceutical Quality Assurance Practical – I | Core Practical | 4 | Calibration of Analytical Instruments, Quality Control Tests for Raw Materials, Analytical Method Validation, Documentation Practices (SOPs, BMR), In-process Quality Control Tests |
| MPQA 106P | Pharmaceutical Quality Assurance Practical – II | Core Practical | 4 | Microbiological Limit Tests, Sterility Testing, Tests for Water for Pharmaceutical Use, Cleanroom Environmental Monitoring, Disinfection and Sanitation Procedures |
Semester 2
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPQA 201T | Quality Control and Assurance of Pharma Products | Core Theory | 4 | Raw Material Quality Control, In-process Quality Control, Finished Product Testing, Impurity Profiling and Analysis, Stability Testing Protocols, Statistical Quality Control |
| MPQA 202T | Regulatory Aspects of Pharmaceutical Quality Assurance | Core Theory | 4 | Major Regulatory Agencies (FDA, EMEA, CDSCO), Drug Laws and Regulations, Intellectual Property Rights, ANDA/NDA Filing Requirements, Pharmacovigilance, Drug Approval Process |
| MPQA 203T | Advanced Instrumental Analysis | Core Theory | 4 | Spectroscopy (UV-Vis, IR, NMR, Mass), Chromatography (HPLC, GC, HPTLC), Electrophoresis Techniques, Thermal Analysis (DSC, TGA), Hyphenated Techniques, Troubleshooting Analytical Instruments |
| MPQA 204T | Good Manufacturing Practices and Auditing | Core Theory | 4 | cGMP Requirements (Schedule M, USFDA, EU), Facility Audits, Supplier Qualification and Audits, Self-Inspection Programs, Quality Risk Management, Deviation Management and CAPA |
| MPQA 205P | Pharmaceutical Quality Assurance Practical – III | Core Practical | 4 | Quality Control of Solid Dosage Forms, Quality Control of Liquid Orals, Aerosol and Parenteral Product Testing, Sampling Techniques, Statistical Process Control Applications |
| MPQA 206P | Pharmaceutical Quality Assurance Practical – IV | Core Practical | 4 | Preparation of Standard Operating Procedures (SOPs), Development of Validation Protocols, Audit Report Writing, Case Studies in Quality Assurance, Application of Quality Software Tools |
Semester 3
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPQA 301T | Hazard Analysis and Critical Control Points (HACCP) | Core Theory | 4 | Principles of HACCP, Implementation Steps of HACCP, Food Safety Management Systems, Risk Assessment in HACCP, Sanitation and Hygiene in Pharma, Hazard Identification |
| MPQA 302T | Validation and Calibration | Core Theory | 4 | Types of Validation (Process, Cleaning, Analytical), Computer System Validation (CSV), Validation Master Plan (VMP), Equipment Qualification (DQ, IQ, OQ, PQ), Calibration of Measuring Instruments, Revalidation and Documentation |
| MPQA 303T | Intellectual Property Rights and Regulatory Affairs | Core Theory | 4 | Patents, Trademarks, Copyrights, Geographical Indications, International IPR Conventions, Regulatory Bodies (USFDA, EMA, ICH), Drug Approval Processes, Documentation for Regulatory Submissions |
| MPQA 304T | Elective | Elective Theory | 4 | |
| MPQA 305P | Pharmaceutical Quality Assurance Practical – V | Core Practical | 4 | Development of Validation Protocols for Processes, Execution of Cleaning Validation Studies, Calibration Procedures for Advanced Equipment, Mock Audit Exercises and Reporting, Quality Metrics and Trend Analysis |
| MPQA 306S | Project Work (Part I) | Project | 16 | Research Methodology, Literature Review and Problem Identification, Experimental Design and Planning, Data Collection and Preliminary Analysis, Scientific Writing and Progress Reporting |
Semester 4
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPQA 401S | Project Work (Part II) | Project | 28 | Advanced Data Analysis and Interpretation, Thesis Writing and Manuscript Preparation, Research Presentation and Communication, Addressing Research Questions and Hypotheses, Defense of Research Findings |
| MPQA 402V | Viva Voce | Viva Voce | 12 | Comprehensive Subject Knowledge Assessment, Defense of Project Work and Methodology, Understanding of Research Implications, Communication and Presentation Skills, Critical Thinking and Problem-Solving |
