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BP806T AECSemester 82 creditsTheory

AEC Elective — Pharmaceutical Packaging / Supply Chain / Industrial Safety / Traditional Healing / AR-VR Pharma 4.0 / Herbal Cosmetics

Complete unit-wise syllabus for BP806T AEC as per the PCI B.Pharm NEP 2020 curriculum (Semester 8 — AI Ethics + Clinical + Final Research).

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Course Objectives

  • Provide students with a comprehensive understanding of pharmaceutical packaging, its principles, materials, processes, and regulatory aspects.
  • Equip students with knowledge of the selection, design, and development of packaging materials for various dosage forms.
  • Educate students on the interaction between packaging and formulation, quality control, and advances in pharmaceutical packaging.
  • Train students in assessing packaging materials for pharmaceutical products in compliance with regulatory guidelines.
  • Prepare students for future roles in pharmaceutical manufacturing, quality assurance, and packaging development.
  • Understand and apply key SCM concepts and frameworks.

Unit-wise Syllabus

6 Units
1
Option 1: BP806T AEC1 — Pharmaceutical Packaging (30 Hours)30 Hours
  • General Information on Packaging
  • Introduction: Purpose of packaging, selection of the ideal package (primary, secondary and tertiary), hazards encountered by the package, various types of inner and outer packages, selection of a suitable package.
  • Packaging materials: Detailed study with regard to composition packaging characteristics, advantages, economics and limitations of various packaging materials with special emphasis on glass, plastics, metals and rubber.
  • Child resistant package, Tamper Evident Packaging, Anti- Counterfeit Packaging, Environmental considerations of packaging (Recycling). Pharmaceutical Packaging – Design and Development
  • Selection and Design of Packaging during Product Development Process (Parameters).
  • Packaging Process: Significance of Strip, Blister, Pouch Packaging, advantages, economics and limitation, Packing machinery and recent advances, films employed in Packing (Video based learning). Formulation Packaging Interaction
  • Polymer Chemistry Science and Stability Aspects
  • Extractable and Leachables
  • Methods to study formulation packaging interaction
  • Suitability considerations for pharmaceutical packaging Quality Assurance, Control and Regulatory Aspects
  • Total Quality management, Good Manufacturing Practice, Quality Risk Management related to Packaging Department, Specification Testing and Shelf-life testing as per Pharmacopoeial Guidelines for Packaging Material in-process and finished Package Products.
  • Standard Operating Procedures (SOPs)/Documentation for Solid/Semi- Solid/Liquid/Parenteral Formulation Packaging. Packaging waste and Waste policies for packaging materials, Advances in Pharmaceutical Packaging
  • Labelling- Types of label (including Bar code, Hologram, RF, structured program, in- mould and decorative labelling) – Use of Software, Legal requirements of Labelling, packaging inserts and outserts. Adhesives and Machinery Employed for Labelling - Pharmacy Accessory Label Printers (PALP), Concept of paperless labelling
  • Logistics Packaging - Block Chain Technology in Supply Traceability, Transparency and Credibility. Review on Automated Packaging System for Oral Solids (Auto-Print), Oral Liquid (Fluidose), and overwrapping (PABS).
2
Option 2: BP806T AEC2 — Supply Chain Management (30 Hours)30 Hours
  • Introduction to Supply Chain Management
  • Introduction to SCM: Definition, scope, Importance of SCM, in global business, Key components and stakeholders, Supply Chain Strategies, Process and barriers of supply chain management.
  • Supply Chain Models: SCOR Model (Plan, Source, Make, Deliver, Return) CSCMP Supply Chain Process Standards.
  • Supply Chain Network Design, Facility location and layout, Transportation planning.
  • Supply Chain Performance Metrics, Key Performance Indicators (KPIs)
  • Performance measurement tools
  • Case Study: SCM in Practice with Real-world examples Procurement and Supplier Management
  • Procurement Fundamentals, Role of procurement in SCM, sourcing strategies
  • Supplier selection criteria, supplier performance evaluation, Collaboration and communication.
  • Global Sourcing, Challenges and opportunities, Cultural considerations, Legal and ethical issues
  • E-Procurement, Electronic procurement systems, Benefits and challenges
  • Case Study: Procurement Excellence, Best practices. Logistics and Distribution Management
  • Logistics Fundamentals, Definition and scope, Importance in SCM
  • Transportation Management, Modes of transportation, Routing and scheduling, Freight cost analysis
  • Inventory Management of pharmaceuticals, Inventory types and functions, Inventory control techniques, Economic Order Quantity (EOQ)
  • Introduction to warehouse functions, Management and Distribution channels and distribution strategies for vaccines and biologicals.
  • Case Study: Logistics and transportation Optimization process, Knowledge and skill sets needed for optimization. Technology and Innovation in SCM
  • Information Technology in SCM, Role of IT in SCM planning and operations management for pharmaceuticals.
  • Enterprise Resource Planning (ERP) systems, operations 6system, Supply Chain Management Softwares.
  • Big Data and Analytics, Importance of data in SCM.
  • Artificial Intelligence and Machine Learning, AI/ML applications in SCM, smart logistics.
  • Demand forecasting, Autonomous vehicles
  • Security and transparency with special emphasis to cybersecurity. Sustainability and Risk Management in SCM
  • Sustainable Supply Chain Management, Green logistics, Circular economy Environmental impact assessment.
  • Ethical Sourcing, Fair trade practices, Labor standards, Supplier audits.
  • Risk Management in SCM, Risk identification and assessment, Risk mitigation strategies, Crisis management with special emphasis to Pharmaceutical products.
  • Regulatory Compliance, International trade regulations, Customs and import/export laws, Compliance standards.
  • Cold chain management, its need, challenges and opportunities in Pharmaceutical products.
  • Case Study: Risk and Sustainability Challenges
3
Option 3: BP806T AEC3 — Industrial Safety and Waste Management (30 Hours)30 Hours
  • Introduction to Industrial Safety
  • Importance of industrial safety in pharmaceutical and chemical industries
  • Types of industrial hazards: physical, chemical, biological, mechanical, electrical
  • Accident prevention techniques
  • Safety signs, symbols, and personal protective equipment (PPE)
  • OSHA guidelines and ISO safety standards Risk Assessment and Hazard Management
  • Hazard identification methods (HAZOP, FMEA)
  • Risk analysis and evaluation
  • Safety audit and checklist
  • Fire hazards and fire-fighting systems
  • Role of safety officer and disaster management planning Waste Management – Fundamentals
  • Classification of industrial waste: hazardous, non-hazardous, solid, liquid
  • Sources of pharmaceutical and chemical waste
  • Waste minimization strategies
  • Recycling, reuse, and resource recovery Environmental impact assessment (EIA) basics Waste Treatment Technologies
  • Physical, chemical, and biological methods of waste treatment
  • Treatment of effluents, emissions, and solid waste
  • Common Effluent Treatment Plants (CETP)
  • Biomedical waste disposal and rules (BMW Rules – India)
  • Guidelines from CPCB, WHO, and MOEFCC Regulatory and Sustainable Practices
  • Environmental Protection Act, Factories Act, Hazardous Waste Rules
  • Good Manufacturing Practices (GMP) related to waste and safety
  • International guidelines: US EPA, EU regulations, WHO
  • Sustainable development goals (SDGs) related to waste and health
  • Case studies of safe and green pharma manufacturing
4
Option 4: BP806T AEC4 — Traditional Healing Practices of India (30 Hours)30 Hours
  • Introduction to Traditional Medicine, Definition and scope of traditional healing Historical evolution of traditional medicine in India Indigenous knowledge systems and oral traditions Health and disease in Indian philosophical thought Integrating Traditional Healing with Modern Medicine What is a traditional healing practice. Traditional healing practice in India. Socio-Scientific Validation and Knowledge Integration Preservation of Socio-Cultural Health Knowledge Ethnoveterinary Empowerment and Rural Health Equity Basic principles: Ayurveda, Panchamahabhuta, Tridosha, Dhatu, Mala Diagnosis and treatment: Pulse diagnosis, Panchakarma, Rasayana, Nadi Parikshan, Marma therapy, Chiropathic treatment, Materia medica (Dravyaguna) and formulation (Rasa Shastra) Current relevance and institutionalization (AYUSH) The study seeks to integrate traditional healing practices into contemporary healthcare systems. Contemporary usage and debates Fostering Transdisciplinary Collaboration Economic Viability and Grassroots Entrepreneurship Siddha and Unani Systems: Siddha: Origin, principles, and therapeutic techniques Unani: Greek-Arabic foundations, four humors, pharmacopoeia Role in South Indian and Indo-Islamic medical heritage Role of traditional healing practice in homeopathy and naturopathy Role of traditional healing practice in homeopathy and naturopathy Development and acceptance in India Role of traditional healing practice in homeopathy and naturopathy Development and acceptance in India Folk and Tribal Healing Practices: Holistic approach to the traditional system, natural methods of healing practices, and cultural significance of the traditional system of medicine. Difference between Indian traditional system of medicine and traditional Chinese medicinal system. Regional practices: Snake stones, ritual healing, herbal knowledge Role of healers: Vaidya, Ojha, Bhopa, Bonesetters, Dai (traditional midwives) Ethnomedicine and ethnobotany: Case studies from North East of India, Chhattisgarh, Himalaya etc. Multidisciplinary longitudinal study to comprehensively document, scientifically validate, and integrate traditional healing systems Spiritual and Religious Healing: Role of Yoga, Pranayama, and meditation Healing through Mantras, rituals, and astrology Use of temples and sacred groves in mental health and well-being Computational studies will complement laboratory investigations by revealing molecular interactions and mechanisms of action, thereby providing scientific rigor to traditional claims. Legal and policy frameworks (AYUSH, WHO recognition) Role of NGOs and community health programs Challenges in validation, standardization, and commercialization Case studies of integration in rural/urban healthcare Protection of Intellectual Property and Cultural Sovereignty Documentation of Indigenous Knowledge System (IKS). Prevention of the Traditional system of medicine.
5
Option 5: BP806T AEC5 — Futuristic Pharma through AR/VR: Pharma 4.0 (30 Hours)30 Hours
  • Hours Introduction to AR/VR and Tools
  • Understanding AR and VR: Concepts, Tools, and Devices
  • Hands-on demo of Google Cardboard, Oculus, or similar headsets
  • Difference between AR, VR, and Mixed Reality (MR)
  • Exploring AR/VR Platforms for Life Sciences
  • Overview of software: Unity 3D, Vuforia, WebAR, JigSpace, ARKit
  • Demo of existing pharma-related AR/VR apps (e.g., Human Anatomy VR) AR/VR in Pharmaceutical Education and Training
  • Use of apps for visualizing drug-receptor interaction
  • Virtual dissection and interactive physiology
  • Simulated tablet compression and coating machines
  • Training modules on aseptic techniques using VR
  • Counseling Patients in a Virtual Pharmacy Setup
  • Use of avatars and scenarios for OTC counseling, prescription explanation
  • Emphasis on communication and empathy in virtual settings AR/VR in Manufacturing and Pharma 4.0 Digital Twin Concept & Virtual Plant Walkthrough
  • Create mock layouts of pharma production plants in AR
  • Navigate a cleanroom and observe equipment placement virtually Smart Maintenance and SOP Training via AR Integrating AR with Sensors and QR-based Inventory
  • Real-world temperature/humidity sensors
  • Live monitoring of warehousing systems Pharma 4.0 Compliance and Regulatory Perspectives
  • Virtual audit readiness
  • Documentation and equipment validation trails using AR mock- ups AR/VR for Patient-Centric Applications Patient Leaflets and Drug Delivery Tutorials
  • Creating content showing how to use inhalers, injectables, or devices
  • Overlay content on medicine boxes or instruction cards AR/VR for Mental Health, Pain, and Rehabilitation Therapy
  • Case studies: VR for phobia therapy, chronic pain, relaxation therapy Digital Adherence Tools with AR Guidance
  • Real-time AR reminders linked to prescription schedules
  • AI avatars for personalized patient nudges Project-Based Integration and Evaluation Mini Project: Create an AR/VR-Based Solution
  • Example: VR tour of GMP plant, AR-based patient education module
  • Demo Unity or online tools like CoSpaces / ZapWorks
6
Option 6: BP806T AEC6 — Herbal Cosmetics for Industry Perspective (30 Hours)30 Hours
  • Introduction to the requirements for an herbal cosmetics industry Market trends, worldwide trade and consumer demand for herbal cosmetics. Advantages and challenges of the herbal cosmetics industry. Requirements for factory location, premises, plant layout and infrastructure and materials. Fundamentals of Entrepreneurship Characteristics and skills of successful entrepreneurs. Types of entrepreneurship: product, process, and quality testing entrepreneurship. Developing Entrepreneurial mind-set. Case studies Success Stories of some successful herbal cosmetic brands (e.g., Forest Essentials, Biotique, Khadi Naturals) Steps involved in setting up a start-up:
  • Identifying gaps in the herbal cosmetics market
  • Business plan development for a herbal cosmetic product
  • SWOT analysis for herbal cosmetics start-ups
  • Technical, financial, and market feasibility study
  • Planning for scalability and sustainability Financial Management and Marketing Strategies Budgeting and cost estimation. Sources of finance: loans, grants, angel investors, venture capital. Government schemes (STARTUP INDIA) and support for MSMEs and herbal industries. Overview on branding essentials – positioning and brand identity. Distribution channels: retail, e-commerce, exports. Digital marketing: social media, Search Engine Optimization (SEO) influencer marketing Legal and Regulatory Framework Licensing and registration for herbal cosmetics as per the Drugs and Cosmetics Act (1940) and rules (1945) of India. The role of CDSCO, AYUSH ministry, FSSAI, ISO, GMP in the herbal cosmetics industry Labelling and packaging norms (Schedule S and role of Bureau of Indian Standards –BIS) Advertising regulation for herbal cosmetics IP rights: patents, trademarks, and protection of herbal knowledge Quality and safety evaluation of herbal cosmetics Importance of quality assurance in herbal cosmetics. Key safety concerns (contamination, allergens, microbial growth). Quality evaluation of herbal raw material. Product-Specific Quality Parameters - Quality standards for creams, lotions, shampoos, oils, face packs, etc. Specific marker compounds and their quantification in herbal products. Toxicological and Safety Evaluation: In vitro and in vivo safety testing (skin irritation, sensitization, eye irritation). Patch testing, Draize test, and OECD guidelines. Use of alternative non-animal testing methods (3D skin models, in silico models)

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Recommended Textbooks & References

  1. 1. Brody, A. L., Marsh, K. S. The Wiley Encyclopedia of Packaging Technology. John Wiley & Sons, New York, USA.
  2. Lachman, L., Lieberman, H. A., Kanig, J. L. The Theory and Practice of Industrial Pharmacy. Lea & Febiger, Philadelphia, USA.
  3. KacChesney, T. C. Packaging of Cosmetics and Toiletries. Newness-Butterworth, London, UK.
  4. Allen, L. V. Jr. Remington: The Science and Practice of Pharmacy. Mack Publishing Company, Easton, USA.
  5. Bauer, E. J. Pharmaceutical Packaging Handbook. CRC Press / Informa Healthcare Ltd, USA.
  6. Dean, D. A., Evans, E. R., Hall, I. H. (Eds.) Pharmaceutical Packaging Technology. CRC Press, USA.
  7. Lockhart, H., Paine, F. A. Packaging of Pharmaceuticals & Healthcare Products. Chapman & Hall, UK.
  8. Harburn, K. Quality Control of Packaging Materials in the Pharmaceutical Industry. CRC Press, USA.

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

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