BP607T AECSemester 61 creditsTheory
AEC Elective — Green Chemistry / Materiovigilance / Scientific Writing / Drug Store Management / Medicinal Plant Cultivation / API Sciences
Complete unit-wise syllabus for BP607T AEC as per the PCI B.Pharm NEP 2020 curriculum (Semester 6 — AI in Pharma + Analysis + Internship II).
URL:
https://pharmacode.vercel.app/syllabus/semester-6/bp607t-aec-aec-elective-green-chemistry-materiovigilance-scientific-writing-drug-store-management-medicinal-plant/Course Objectives
- Comprehend the foundational principles and overarching scope of green chemistry within pharmaceutical sciences.
- Analyze and evaluate the environmental impact of traditional pharmaceutical manufacturing processes and the significance of green chemistry metrics.
- Acquire knowledge of diverse green chemical techniques, including alternative solvents and various catalytic approaches, for sustainable drug synthesis.
- Recognize the industrial application of green chemistry principles in pharmaceutical manufacturing processes, focusing on waste minimization and pollution control.
- To articulate the principles of green chemistry.
- Understand the concepts, scope, and importance of materiovigilance and hemovigilance systems in ensuring patient safety in healthcare.
Unit-wise Syllabus
6 Units1
Option 1: BP607T AEC1 — Green Chemistry (15 Hours)15 Hours- Introduction to Green Chemistry in Pharmacy
- Definition and scope of green chemistry in pharmaceutical sciences
- Principles of Green Chemistry with pharmaceutical examples Environmental Aspects and Metrics in Green Pharmacy
- Comparison of traditional vs. green chemical approaches in drug synthesis
- Environmental impact of pharmaceutical manufacturing
- Overview of pharmaceutical pollutants and their life cycle
- Metrics: Atom economy, E-factor, Process Mass Intensity (PMI) Green Techniques in Pharmaceutical Synthesis – I
- Green Solvents and use of green solvents (e.g. water, supercritical fluids, ionic liquids) in drug synthesis
- Solvent-free reactions in pharmaceutical synthesis
- Green Catalysis and Reaction Enhancement in pharmaceutical green chemistry – Overview of catalysis in pharmaceutical green chemistry, Photochemical Transformations, Phase Transfer Catalysis Green Techniques in Pharmaceutical Synthesis – II
- Microwave assisted reactions: Merit and demerits of its use
- Mechanism, superheating effects of microwave
- Effects of solvents in microwave assisted synthesis
- Microwave technology in process optimization
- Applications in various organic reactions and heterocycles synthesis Green Chemistry in Industrial and Regulatory Aspects
- Green chemistry in pharmaceutical manufacturing processes
- Ultrasound assisted reactions: Types of sonochemical reactions, synthetic applications
- Continuous flow reactors: Working principle, advantages and synthetic applications
- Waste minimization and pollution control in formulation industries
- Role of green chemistry in Good Manufacturing Practices (GMP)
2
Option 2: BP607T AEC2 — Materiovigilance and Hemovigilance (15 Hours)15 Hours- Introduction to Vigilance Systems
- Overview of Materiovigilance, Hemovigilance and other vigilance system in Healthcare
- Importance of post-marketing surveillance in patient safety
- Scope and objectives of materiovigilance and hemovigilance programs
- Basic concepts of adverse event reporting and safety monitoring
- Historical evolution and global relevance of Materiovigilance, Hemovigilance practices Materiovigilance – Principles and Practices
- Introduction to Materiovigilance Programme of India (MvPI)
- Roles of NCC-MvPI and technical collaborators (e.g., Sree Chitra Tirunal Institute)
- Classification of medical devices (Class A to D) based on risk
- Identification and documentation of Medical Device Adverse Events (MDAEs)
- Medical device reporting forms, process flow, and responsibilities
- Causality assessment of Medical Device Adverse Events Hemovigilance – Principles and Practices
- Overview of Hemovigilance Programme of India (HvPI)
- Organizational structure: NIB, NBTC, hospital-based hemovigilance
- Adverse Transfusion Reactions (ATRs): Types and clinical manifestations
- Use of TRRF (Transfusion Reaction Reporting Form) and Haemo- Vigil software
- Responsibilities of blood banks, transfusion officers, and healthcare providers
- Case examples along with Causality assessment of Hemolytic reactions, TRALI, TACO, allergic responses. Global s, Risk Assessment & Root Cause Analysis
- International frameworks: US FDA (MAUDE), EU MDR, SHOT (UK), French Hemovigilance
- Comparison of Indian and global materiovigilance/hemovigilance practices
- Signal detection and evaluation of adverse events
- Root cause analysis (RCA) and implementation of corrective & preventive actions (CAPA)
- Risk communication and role of healthcare teams in mitigation Reporting Systems, Quality Assurance, and Professional Role Demonstration: Reporting of MDAEs and ATRs using mock forms
- Practical exercises in form-filling and event documentation
- Integration of vigilance into hospital quality systems (e.g., NABH, ISO)
- Strategies to enhance adverse event reporting culture
- Ethical considerations and communication with patients/families
- Role of pharmacists, nurses, clinicians, biomedical engineers in vigilance programs
3
Option 3: BP607T AEC3 — Scientific Writing (15 Hours)15 Hours- Introduction to Scientific Writing
- Overview of the course
- Principles of scientific writing
- Overview of scientific research
- Introduction to Microsoft tools and its application Writing Literature Reviews and Scientific Papers
- Structure and format of literature reviews
- Conducting a literature review
- Analyzing literature and developing themes
- Writing a compelling introduction
- Developing a clear methodology
- Results and analysis Communicating Results and Data
- Understanding data presentation
- Developing tables and figures
- Using effective graphic design Scientific Citation and Referencing
- Understanding citation styles
- Citation and plagiarism
- Referencing in scientific writing Ethical Issues in Scientific Writing and Peer Review and Revision
- Ethical principles in scientific writing
- Misconduct and fraud in scientific writing
- Peer review and publication ethics
- Providing Constructive feedback
- Responding to feedback
4
Option 4: BP607T AEC4 — Drug Store and Business Management (15 Hours)15 Hours- Introduction to Trade and Industry
- Objectives and scope of business
- Classification of business activities – industry, commerce, trade
- Forms of business organization: sole proprietorship, partnership, cooperatives, corporations
- Features and merits/demerits of each form Pharmacy business and its legal considerations Drug Store Management
- Selection of site, space, and layout of a drug store
- Types of drug stores – hospital pharmacy, community pharmacy, chain pharmacy
- Procurement of drugs and inventory control
- Storage conditions and stock maintenance (cold storage, poisonous drugs, etc.)
- Records and registers to be maintained Inventory Control and Sales Promotion
- Introduction to inventory control: need and methods
- Economic Order Quantity (EOQ), Reorder Level (ROL), Lead time
- FIFO and LIFO methods
- Sales promotion techniques: advertising, displays, discounts
- Customer relationship management (CRM) in pharmacy Financial Management and Bookkeeping
- Basics of accounting: journal, ledger, trial balance
- Introduction to financial statements: profit and loss account, balance sheet
- Pricing policies: markup, markdown, break-even analysis
- Bank transactions: types of accounts, cheques, drafts
- Taxation basics: GST, income tax (as applicable to pharmacies) Pharmaceutical Marketing and Entrepreneurships
- Definition and scope of pharmaceutical marketing
- Elements of marketing mix (4Ps) for pharmacy
- Drug distribution channels: wholesale and retail
- Entrepreneurship development in pharmacy
- Regulatory aspects of retail drug licensing (Drug and Cosmetics Act overview)
5
Option 5: BP607T AEC5 — Career Building in Cultivation of Medicinal Plants (15 Hours)15 Hours- Introduction and Industry Overview
- Definition, importance, and cultural background (Ayurveda & ethnobotany)
- Global and Indian demand, healthcare and pharma role
- Key stakeholders: farmers, traders, processors, exporters
- Value chain, supply-demand, government/private initiatives (NMPB, AYUSH, NABARD) Key Medicinal Plants and Cultivation Basics
- Botanical characteristics and uses of major plants: Ashwagandha, Tulsi, Aloe vera, Shatavari, Brahmi, etc.
- Regional suitability and agro-climatic zones
- Factors affecting Cultivation: Soil, propagation, irrigation, pest control, organic inputs
- Harvesting, post-harvest management and storage Organic Farming and Market Linkages
- Organic certification and sustainable farming practices
- Biodiversity conservation and agroforestry integration
- Processing, drying, packaging, branding
- Market linkages: pharma, cooperatives, online platforms, export guidelines Policy, Entrepreneurship and Digital Tools
- Government schemes and legal frameworks (NMPB, AYUSH, forest laws, GACP)
- Entrepreneurship: starting herbal farms, franchises, consulting, contract farming
- Digital tools: farm management software, GIS, mobile apps, e- commerce marketing Practical Exposure and Project Presentation
- Virtual/shortened farm/nursery visit or guest lecture (can be online)
- Group/individual project: business plan or herbal enterprise pitch presentation
6
Option 6: BP607T AEC6 — Active Pharmaceutical Ingredients and Excipient Sciences (15 Hours)15 Hours- Introduction to APIs and Excipients
- Definitions, classifications, and sources (synthetic, natural, biotech APIs; functional excipients).
- Physicochemical properties: Solubility, polymorphism, hygroscopicity, particle characteristics.
- Roles in formulations: Bioavailability enhancement, stability, manufacturability.
- Industry overview: Global market trends, common examples (e.g., paracetamol API, HPMC excipient). Methodologies for Selection and Pre-formulation
- Excipient selection criteria: Functionality-related characteristics (FRC).
- Compatibility studies: Binary mixtures via DSC, FTIR, XRD.
- Analytical methodologies: HPLC/GC for purity, Karl Fischer titration, laser diffraction for PSD.
- QbD approach: Risk assessment for API-excipient interactions. Manufacturing Protocols
- API processes: Synthesis routes, crystallization, drying, milling
- lab- to-pilot scale-up.
- Excipient handling: Sieving, blending, lubrication protocols.
- GMP essentials: Equipment qualification, process validation.
- Unit operations: Wet/dry granulation, direct compression. Quality Control and Stability Protocols
- QC tests: Assay, dissolution, content uniformity (IP/USP methods).
- Stability studies: ICH Q1A zones, accelerated/forced degradation.
- Impurity profiling: Genotoxic impurities (ICH M7), residual solvents.
- In-process controls: Blend uniformity, weight variation. Regulatory Compliance and Industry Practices
- ICH Q7 guidelines for APIs
- USP-NF excipient monographs and Schedule M requirements
- Drug Master File (DMF) for APIs
- Certificate of Suitability (COS) for excipients
- Process and cleaning validation protocols
- Regulatory inspections (USFDA 483, EMA expectations)
- Emerging trends: green chemistry and bio-based excipients
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Recommended Textbooks & References
- Anastas, P.T. and Warner, J.C., 2000. Green chemistry: theory and practice. Oxford university press.
- Lancaster, M. (2016). Green Chemistry: An Introductory Text (3rd ed.). Royal Society of Chemistry.
- Green Chemistry in the Pharmaceutical Industry, Edited by Peter J. Dunn, Andrew Wells, and Michael T. Williams, 2010.
- Green Chemistry and Sustainable Technology: Biological, Pharmaceutical, and Macromolecular Systems, Edited by Satish A. Dake, Ravindra S. Shinde, Suresh C. Ameta, A. K. Haghi, 2022.
- Scalable Green Chemistry: Case Studies from the Pharmaceutical Industry, Edited by Stefan Koenig, 2013.
- 1. Bertil Jacobson - Medical Device Safety: The of Medical Devices for Public Health and Safety, CRC Press
- Jack Wong - Handbook of Medical Device Regulatory Affairs in Asia, Pan Stanford Publishing
- Denise M. Harmening - Modern Blood Banking and Transfusion Practices, F.A. Davis Company
What's coming next on this page
- Previous year question papers (PYQ)
- Topic-wise short notes and revision summaries
- MCQs and self-assessment quizzes
- Suggested external resources and video tutorials
Other subjects in Semester 6
BP601TAdvanced PharmacognosyBP602TBiopharmaceutics and PharmacokineticsBP603TIntellectual Property RightsBP604TAI Applications in Pharmaceutical SciencesBP605TPharmaceutical AnalysisBP606TPharmaceutical JurisprudenceBP608PBiopharmaceutics and Pharmacokinetics (Practical)BP609PPharmaceutical Analysis (Practical)BP610P SECSEC Elective — Computer-Aided Drug Design / Analytical Method Development / Principles of Preclinical Studies (Practical)BP611P VACVAC Elective — Professional Skills / Process Analytical Technology & Quality by Design (Practical)BP612IInternship II (Mandatory)