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M-PHARM in Pharmaceutical Quality Assurance at SRM Institute of Science and Technology
Chengalpattu, Tamil Nadu
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About the Specialization
What is Pharmaceutical Quality Assurance at SRM Institute of Science and Technology Chengalpattu?
This Pharmaceutical Quality Assurance program at SRM Institute of Science and Technology focuses on equipping graduates with in-depth knowledge and skills essential for ensuring the safety, efficacy, and quality of pharmaceutical products. It covers regulatory compliance, quality management systems, and advanced analytical techniques crucial for the Indian pharmaceutical industry. The program emphasizes adherence to global standards like ICH and GMP, reflecting the sector''''s stringent requirements.
Who Should Apply?
This program is ideal for Bachelor of Pharmacy graduates seeking entry into the specialized field of pharmaceutical quality. It also caters to working professionals in pharmaceutical manufacturing or R&D who aim to upskill and take on leadership roles in quality assurance, regulatory affairs, or quality control. The curriculum is designed for those committed to upholding rigorous quality standards in drug production and development.
Why Choose This Course?
Graduates of this program can expect promising career paths in Indian pharmaceutical companies, contract research organizations (CROs), and regulatory bodies. Roles include Quality Assurance Manager, Regulatory Affairs Executive, Quality Control Analyst, and Validation Scientist, with entry-level salaries typically ranging from INR 3.5 to 6 LPA, growing significantly with experience. The program aligns with industry demand for skilled professionals who can navigate complex regulatory landscapes.
Student Success Practices
Foundation Stage
Deep Dive into Regulatory Basics- (Semester 1-2)
Focus intensely on understanding core regulatory guidelines like ICH, GLP, and GMP. Utilize official documents and online resources from regulatory bodies (e.g., USFDA, CDSCO). Participate in peer study groups to discuss complex compliance scenarios and case studies.
Tools & Resources
ICH guidelines website, CDSCO India website, WHO GMP guidelines, Quality assurance handbooks, Peer discussion forums
Career Connection
Strong foundational knowledge is critical for roles in Quality Assurance and Regulatory Affairs, enabling confident application of compliance principles in industry.
Hands-on Analytical Skill Development- (Semester 1-2)
Maximize practical lab hours, focusing on mastering modern pharmaceutical analytical techniques (HPLC, GC, UV-Vis, Mass Spec). Seek additional opportunities for instrument calibration, method development, and validation under faculty supervision. Maintain a meticulous lab notebook.
Tools & Resources
University analytical labs, Instrument manuals, Online tutorials for specific instruments, Laboratory simulation software if available
Career Connection
Proficiency in advanced analytical instruments is a direct requirement for Quality Control Analyst and R&D roles, making graduates immediately employable.
Build a Strong Research & Communication Base- (Semester 1-2)
Actively engage in Seminar/Journal Club sessions by presenting on recent scientific articles and critical analyses. Develop effective scientific writing skills through early literature reviews and small research proposals, seeking feedback from professors.
Tools & Resources
PubMed, Google Scholar, Mendeley/Zotero for referencing, University library resources, Presentation software (PowerPoint, Prezi)
Career Connection
Enhances research aptitude and scientific communication, vital for project work, higher studies, and technical report writing in pharmaceutical companies.
Intermediate Stage
Advanced Stage
Focused Project Work & Validation Expertise- (Semester 3-4)
Select a project topic closely aligned with current industry validation challenges (process, analytical, cleaning, computer system validation). Work diligently on Phase-I (literature, design) and Phase-II (execution, analysis, thesis). Seek industry mentorship if possible for practical insights.
Tools & Resources
Validation guidelines (e.g., ISPE, FDA), Statistical software (e.g., R, SPSS), Specific validation protocols and templates, Faculty guidance
Career Connection
A well-executed project demonstrates practical validation skills, a highly sought-after expertise for Validation Scientist and QA Specialist roles.
Master Auditing & Documentation Skills- (Semester 3-4)
Actively study documentation practices (SOPs, BMR, MFR) and audit methodologies (internal, external, regulatory). Participate in mock audits if offered or simulate audit scenarios with peers. Focus on identifying and resolving quality discrepancies (CAPA).
Tools & Resources
GMP documents, ISO standards, Quality audit checklists, Online courses on CAPA management, Pharmaceutical industry case studies
Career Connection
Essential for roles as Quality Auditor, QA Executive, and Regulatory Affairs professionals who manage compliance and oversight.
Network and Pursue Industry Certifications- (Semester 3-4)
Attend industry webinars, conferences, and guest lectures to network with professionals. Explore professional certifications like ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) post-graduation. Tailor your resume and LinkedIn profile to reflect specialization expertise for placements.
Tools & Resources
LinkedIn, Industry associations (e.g., IPA, ISPE), Professional certification bodies (ASQ), Career services department
Career Connection
Builds professional network, enhances employability through recognized certifications, and directly supports successful placement in top pharmaceutical firms.
Program Structure and Curriculum
Eligibility:
- B.Pharm degree or equivalent with a minimum of 55% aggregate marks
Duration: 2 years (4 semesters)
Credits: 85 Credits
Assessment: Internal: 40% (Theory), 50% (Practical/Project), External: 60% (Theory), 50% (Practical/Project)
Semester-wise Curriculum Table
Semester 1
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| PQA21101 | Modern Pharmaceutical Analytical Techniques | Core | 4 | Spectroscopy (UV-Visible, IR, Mass, NMR), Chromatography (HPLC, GC), Electrophoresis, Thermal methods of analysis, X-ray diffraction, Atomic absorption |
| PQA21102 | Quality Management Systems | Core | 4 | Quality concepts, ICH guidelines, GLP, GMP, ISO series, Quality Audit, Documentation, Validation Master Plan |
| PQA21103 | Product Development and Quality Control | Core | 4 | Preformulation, Formulation development, Stability studies, Impurities in drug substances, Regulatory aspects of quality control, Packaging materials |
| PQA21104 | Good Manufacturing Practices and Regulatory Affairs | Core | 4 | GMP regulations (USFDA, WHO, EU), Regulatory filings (ANDA, NDA), CTD format, Quality by Design (QbD), Drug discovery and development |
| PQA21105 | Pharmaceutical Quality Assurance Lab-I | Lab | 3 | Analytical instrument handling, Calibration, Method validation, Impurity profiling, Stability testing, Quality control tests |
| PQA21106 | Seminar / Journal Club | Core | 1 | Presentation skills, Scientific literature review, Critical analysis, Communication, Research methodology |
Semester 2
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| PQA21201 | Hazard Analysis and Critical Control Points (HACCP) and Total Quality Management (TQM) | Core | 4 | HACCP principles, TQM philosophy, Six Sigma, Lean manufacturing, Risk management, Process validation |
| PQA21202 | Biostatistics and Research Methodology | Core | 4 | Research designs, Data collection, Statistical analysis (ANOVA, Regression), Hypothesis testing, Clinical trials, Ethical considerations |
| PQA21203 | Documentation and Audits | Core | 4 | Types of documents (SOPs, BMR, MFR), Data integrity, Audit types (internal, external, regulatory), Audit preparation and follow-up, CAPA |
| PQA21204 | Pharmaceutical Packaging and Storage | Core | 4 | Packaging materials (glass, plastic, metal), Container closure systems, Packaging integrity tests, Stability chambers, Storage conditions, Supply chain quality |
| PQA21205 | Pharmaceutical Quality Assurance Lab-II | Lab | 3 | Microbiological quality control, Sterility testing, Endotoxin testing, Environmental monitoring, Water quality analysis, Package testing |
| PQA21206 | Seminar / Journal Club | Core | 1 | Advanced topics in PQA, Recent developments, Patenting, Ethical review, Scientific presentation |
Semester 3
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| PQA21301 | Pharmaceutical Validation | Core | 4 | Validation concepts, Process validation, Analytical method validation, Cleaning validation, Equipment qualification, Computer system validation |
| PQA21302 | Quality Assurance in Clinical Research | Core | 4 | GCP guidelines, Clinical trial phases, Data management in clinical trials, Audits in clinical research, Pharmacovigilance, Ethical committees |
| PQA21EL01 | Elective - I | Elective | 4 | Choice from:, PQA21E01 - Bio-pharmaceuticals and Quality Assurance (Biologics, Biosimilars, Vaccine QA), PQA21E02 - Advanced Instrumental Techniques (LC-MS, GC-MS, hyphenated techniques), PQA21E03 - Intellectual Property Rights and Regulatory Affairs (Patents, Trademarks, IP protection) |
| PQA21304 | Project Work (Phase-I) | Project | 10 | Literature review, Problem identification, Research proposal development, Experimental design, Data analysis planning |
Semester 4
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| PQA21EL02 | Elective - II | Elective | 4 | Choice from:, PQA21E01 - Bio-pharmaceuticals and Quality Assurance (Biologics, Biosimilars, Vaccine QA), PQA21E02 - Advanced Instrumental Techniques (LC-MS, GC-MS, hyphenated techniques), PQA21E03 - Intellectual Property Rights and Regulatory Affairs (Patents, Trademarks, IP protection) |
| PQA21402 | Project Work (Phase-II) | Project | 10 | Experimentation, Data collection and analysis, Interpretation of results, Thesis writing, Scientific presentation, Viva voce |
