B.Pharm 8th Semester New Syllabus 2026-27

Ethical Considerations and Translational Applications of AI in Pharmacy

(Theory – BP801T)

UNIT-1: AI Lifecycle, Validation & Model Auditing

• Overview of AI system lifecycle: data collection, preprocessing, modeling, validation, deployment, and monitoring
• Importance of data quality in healthcare datasets
• Training vs testing vs validation datasets
• Cross-validation (conceptual understanding)
• Model drift and performance degradation, data leakage in modeling
• Documentation practices: Documentation and reproducibility
• Basics of model auditing

• Overview of AI in regulatory submissions
• Explainable AI (XAI) concept
• Transparency and interpretability
• Overview of regulatory guidance on AI (EU AI Act, FDA/CDSCO frameworks)
• Accountability in automated decision systems
• Risk-based classification of AI systems

• Overview of AI in automated dispensing systems
• Inventory prediction models
• Case studies on regression-based demand forecasting, different forecasting methods
• Medication adherence monitoring systems
• AI in supply chain risk prediction
• Predictive analytics in pharmaceutical logistics
• Advantages, limitations, legal & privacy considerations of AI in pharmacy automation.

• Overview of real-world data sources (EHR, claims, surveillance systems)
• Conceptual knowledge of AI in outbreak prediction, Population-level risk modeling
• Regression models in epidemiology
• AI in vaccination forecasting
• Case studies: AI applications in epidemiological trend analysis (e.g. COVID-19 vaccination hesitancy, diabetes prevalence forecasting, antibiotic resistance trends etc.)

• Students implement a supervised ML model (regression, logistic regression, or others) using real-world pharmacy data from domains like formulation, pharmacokinetics (PK), ADR detection, quality control (QC), automation, or public health. They validate the model, analyze regulatory implications, identify ethical risks
• (e.g., bias, privacy), and present a structured AI implementation plan for peer/faculty review.
• Suggested topics (not exhaustive): ADR prediction system, stability forecasting, demand prediction, QC failure model, disease risk prediction, medication adherence

Clinical Pharmacotherapeutics

(Theory – BP802T)

Definition, etiopathogenesis, clinical manifestations, overview of management of the diseases associated with

UNIT-1: Ischemic Heart Disease

• Hypertension, heart failure, myocardial infarction, hyperlipidaemia, arrhythmia

• Asthma, COPD

• acute renal failure, chronic renal failure, renal replacement therapy

• diabetes, thyroid disorders

• epilepsy, stroke, parkinsonism

• peptic ulcer disease, GERD

• Rheumatoid arthritis, osteoarthritis

• tuberculosis, pneumonia, UTI, malaria, HIV

• Anemia

Industrial Pharmacy and Facility Design

(Theory – BP803T)

UNIT-1:

• Regulatory guidelines for formulation Development: ICH Q8, QbD and optimization (Fundamental terminologies, process and applications)
• ICH guidelines of stability testing
• Industrial aspects of Product development
• Pilot Plant and Scale up: General considerations including significance of personnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to platform technology

• Technology development and transfer: WHO guidelines for Technology Transfer(TT): Terminology, Technology
• transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation,
• Premises and equipments, qualification and validation, quality control and analytical method transfer.
• TT agencies in India – APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation – confidentiality agreement, licensing, MoUs, legal issues

• Facility Considerations: Non sterile
• Facility design according to schedule M for various dosage forms, Water purification system: design and operation, Storage, distribution, and validation of water systems. Different types of waters. Steam systems and Clean Steam, Compressed air, Vacuum, CIP. Industry standards for water and steam systems. Effluent testing facility: Design and significance.
• Layout design for various non- sterile dosage forms (Process flow)
• Cleaning and disinfection protocols, cleaning types (Type A, B and C), Cleaning validation methods and acceptance criteria

• Facility considerations: Sterile – Overview of sterile pharmaceutical manufacturing: layout as per schedule M and cGMP, clean room concept -Importance of sterility and contamination control, SIP. efficient material and personnel flow to maintain sterility, zoning and segregation, Guidelines, standards and Cleanroom classifications from FDA, EMA, WHO and ISO.
• Heating, ventilation and air conditioning system (HVAC): Significance, components, testing (including efficiency and integrity testing of HEPA).
• Parameters for qualification and validation (routine monitoring) of clean area.

• Advances in facility design
• Modular concept of manufacturing facilities with significance and suitable examples, Advances in clean room technology: pass- through chambers, isolators, Modular cleanrooms
• Automation and robotics in pharmaceutical manufacturing operations.

Pharmaceutical Management

(Theory – BP804T)

UNIT-1: Introduction to Pharmaceutical Management

• Introduction to management. Overview of Indian & Global pharmaceutical industry, Role and responsibilities of a pharmaceutical manager.
• Functions and importance of Key Management Principles: Planning, organizing, leading, controlling, Decision-making and Time management.

• Definition and uniqueness of pharmaceutical marketing, Pharmaceutical Marketing Overview; Global & Indian Scenario, Marketing Mix, 4 Ps of Marketing: Product, Price, Place, Promotion, Strategic marketing and competitive analysis, Pharmaceutical Sales: Role of a medical representative, Digital marketing of pharmaceutical products, Ethicalconsiderations in pharmaceutical marketing and promotion, E pharmacies

• Introduction to Pharmaceutical Product Management, role of product management in the pharmaceutical industry, Key responsibilities of a pharmaceutical product manager, Product Lifecycle Management,
• Branding and Promotional Strategies in pharmaceutical sector, Importance of market segmentation, targeting, and positioning in productmanagement, Market Research and Analysis in pharmaceutical sector: Techniques for conducting market research.

• Budgeting, financial forecasting, cost control, Pricing of Pharmaceuticals as per DPCO, Importance of human resource management in pharmaceutical organizations, Recruitment, selection, and training of pharmaceutical professionals, Performance appraisal and employee motivation, Behaviour, Leadership styles and their impact on the pharmaceutical industry, Team building and conflict resolution.

• Operations Management, Production planning and control in pharmaceutical manufacturing, Inventory management and optimization, Lean manufacturing and Six Sigma in the pharmaceutical industry, Supply Chain Management, Logistics management and drug distribution channels, Cold chain management and the role of technology in SCM, Ecommerce and its role in pharmaceutical distribution, Risk Management and Sustainability.

(Practical – BP807P)

1. Conduct a comparative study of Indian and global pharmaceutical marketing approaches.
2. Study and classify different marketing communication styles in the pharmaceutical industry.
3. Design and conduct primary market research on prescription pharmaceutical products and analyze the data.
4. Design and conduct primary market research on OTC products and analyze the data.
5. Create and deliver a product detailing presentation for healthcare professionals.
6. Design a patient education program or presentation for pharmaceutical products targeting consumers.
7. Develop and present communication strategies for OTC products for both healthcare professionals and consumers.
8. Design a product promotion scheme and create a brand strategy for a pharmaceutical product.
9. Develop a sales strategy for a pharmaceutical product focusing on distribution channels and promotional tactics for retailers/distributors.
10. Design a mock-up or prototype of an e-commerce website for pharmacy.
11. Design a digital marketing campaign for a pharmaceutical or cosmetic product using social media, email marketing, and SEO techniques.
12. Create a product positioning statement including the Unique Selling Proposition (USP) for a new pharmaceutical product.

Sterile Dosage Forms and Novel Drug Delivery System

(Theory – BP805T)

UNIT-1: Fundamentals, Polymers & Materials for NDDS

• Limitations of conventional dosage forms (e.g., solubility, permeability, toxicity, first-pass metabolism)
• Classification of NDDS: Controlled Release, Targeted, StimuliResponsive (Smart), Chronotherapeutic, Transdermal and Mucosal, Implantable and Injectable Depot Systems, Vesicular, Polymeric, Ocular, Pulmonary, and Nasal Drug Delivery Systems
• Biodegradable and biocompatible polymers: PLA, PLGA, PCL, chitosan, gelatin
• Lipids and surfactants: lecithin, phospholipids, Span/Tween, SLNs
• Inorganic systems: silica, gold nanoparticles, iron oxide, MOFs
• Excipients in NDDS: GRAS substances, IIG database, regulatory constraints

• Gastro-retentive systems: floating, bioadhesive, expandable systems
• Colon-targeted systems: pH-triggered, microbially-triggered, timedependent systems
• Buccal, nasal, and pulmonary carriers: films, sprays, DPIs, liposomes
• IVIVC and biorelevant dissolution testing.

• Introduction to Transdermal drug delivery: Need, advantages disadvantages, basic structure and components. Formulation aspects including permeation enhancers.
• Long-acting systems: in-situ gels, microspheres, implants, ocular inserts
• Transdermal and microneedle technologies: iontophoresis, sonophoresis, micro needles
  Aseptic manufacturing, scale-up challenges, and process analytical tools (PAT)

• Preformulation and QbD: QTPP, CQAs, CPPs
• Characterization methods: particle size, zeta potential, SEM/TEM, in-vitro release, permeability assays (PAMPA, Caco-2)
• Non-clinical evaluation: PK/PD modeling, biodistribution, toxicology
• Regulatory pathways: 505(b)(2), complex generics, ICH Q8–Q10, EMA pathways
• Case studies: Liposomal Amphotericin B for Fungal Infections, mRNA-Lipid Nanoparticle Vaccines (e.g., COVID-19 Vaccines), Depot Antipsychotic Injections (e.g., Risperidone Microspheres), Transdermal Patch for Hormone Replacement Therapy, Ocular Inserts for Glaucoma Management, Oral Colon-Targeted Delivery for Inflammatory Bowel Disease, Inhalable Insulin for Diabetes Mellitus, Dendrimers for Targeted Cancer Therapy, Chronotherapeutic Drug Delivery in Hypertension.
• Nanosystems and precision medicine
  a) Liposomes, niosomes, transferosomes, polymeric nanoparticles, solid-lipid nanoparticles, dendrimers.
  b) Precision medicine: definition and scope, evolution from” onesize-fits-all” to personalized approaches

• Introduction & classification: SVP vs LVP; routes; Advantages/limitations.
• Water for Injection (WFI): Types, preparation, storage/distribution; pharmacopoeial requirements.
• Formulation components: Vehicles, buffers, co-solvents, surfactants, antioxidants, preservatives, chelators; isotonicity & osmolality.
• Manufacturing: Aseptic vs terminal sterilisation; filtration; lyophilisation principles; environmental controls.
• Containers & closures: Glass/Plastic systems; elastomers; selection factors; evaluation & container– closure integrity. Form fill Seal and Blow Fill Seal Technology
• Ophthalmics: Solutions/suspensions/ointments/gels/inserts; physiological factors (pH, tonicity, viscosity); residence-time enhancers; preservative-free systems (e.g., BFS).
• Quality control & compliance: Sterility tests, LAL/endotoxins, particulate matter, clarity, extractable volume; labelling & documentation; overview of cGMP/cleanrooms and environmental monitoring.

(Practical – BP808P)

(Minimum 12 experiments must be performed)

1. Preparation and evaluation of orodispersible tablets
2. Preparation and evaluation of fast dissolving tablets.
3. Preparation and evaluation of bilayer tablets
4. Preparation and evaluation of osmotic tablets
5. Preparation and evaluation of microspheres by coacervation phase separation technique
6. Preparation and evaluation of microcapsules
7. Preparation and evaluation of bioadhesive buccal patches
8. Preparation and evaluation of sublingual tablets
9. Preparation and evaluation of buccal tablets
10. Preparation and evaluation of transdermal patches
11. Preparation and evaluation of floating tablets
12. Preparation and evaluation of gastro retentive drug delivery systems
13. Preparation and evaluation of liposomes
14. Preparation and evaluation of niosomes
15. Preparation and evaluation of nasal spray
16. Preparation and evaluation of a parenteral preparation.
17. Evaluation of pharmaceutical waters: Purified & Distilled Water as per IP; review of WFI specifications (conductivity/ TOC limits-demo / simulation).

BP810RP Research Project

ELECTIVE SUBJECTS

ELECTIVE THEORY SUBJECTS – BP806T AEC*

Pharmaceutical Packaging

(Theory – BP806T AEC1)

UNIT-1: 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, AntiCounterfeit Packaging, Environmental considerations of packaging (Recycling).

• 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).

• Polymer Chemistry Science and Stability Aspects
• Extractable and Leachables
• Methods to study formulation packaging interaction
• Suitability considerations for pharmaceutical packaging

• Total Quality management, Good Manufacturing Practice, Quality RiskManagement 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/SemiSolid/Liquid/Parenteral Formulation Packaging. Packaging waste and Waste policies for packaging materials

• 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).

Supply Chain Management

(Theory – BP806T AEC2)

UNIT-1: Introduction to Supply Chain Management

• o 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.
• o Supply Chain Models: SCOR Model (Plan, Source, Make, Deliver, Return) CSCMP Supply Chain Process Standards.
• o Supply Chain Network Design, Facility location and layout, Transportation planning.
• o Supply Chain Performance Metrics, Key Performance Indicators (KPIs)
• o Performance measurement tools
• o Case Study: SCM in Practice with Real-world examples

• o Procurement Fundamentals, Role of procurement in SCM, sourcing strategies
• o Supplier selection criteria, supplier performance evaluation, Collaboration and communication.
• o Global Sourcing, Challenges and opportunities, Cultural considerations, Legal and ethical issues
• o E-Procurement, Electronic procurement systems, Benefits and challenges
• o Case Study: Procurement Excellence, Best practices.

• o Logistics Fundamentals, Definition and scope, Importance in SCM
• o Transportation Management, Modes of transportation, Routing and scheduling, Freight cost analysis
• o Inventory Management of pharmaceuticals, Inventory types and functions, Inventory control techniques, Economic Order Quantity (EOQ)
• o Introduction to warehouse functions, Management and Distribution channels and distribution strategies for vaccines and biologicals.
• o Case Study: Logistics and transportation Optimization process, Knowledge and skill sets needed for optimization.

• o Information Technology in SCM, Role of IT in SCM planning and operations management for pharmaceuticals.
• o Enterprise Resource Planning (ERP) systems, operations 6system, Supply Chain Management Softwares.
• o Big Data and Analytics, Importance of data in SCM.
• o Artificial Intelligence and Machine Learning, AI/ML applications in SCM, smart logistics.
• o Demand forecasting, Autonomous vehicles
• o Security and transparency with special emphasis to cybersecurity.

• o Sustainable Supply Chain Management, Green logistics, Circular economy Environmental impact assessment.
• o Ethical Sourcing, Fair trade practices, Labor standards, Supplier audits.
• o Risk Management in SCM, Risk identification and assessment, Risk mitigation strategies, Crisis management with special emphasis to Pharmaceutical products.
• o Regulatory Compliance, International trade regulations, Customs and import/export laws, Compliance standards.
• o Cold chain management, its need, challenges and opportunities in Pharmaceutical products.
• o Case Study: Risk and Sustainability Challenges

Industrial Safety and Waste Management

(Theory – BP806T AEC3)

UNIT-1: 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

• 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

• 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

• 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

• 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

Traditional Healing Practices of India

(Theory – BP806T AEC4)

UNIT-1:

• 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.

Futuristic Pharma through AR/VR:Pharma 4.0

(Theory – BP806T AEC5)

UNIT-1: 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)

• 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

• 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 mockups

• 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

• 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

Herbal Cosmetics for Industry Perspective

(Theory – BP806T AEC6)

UNIT-1:

• 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.

• 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

• 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

• 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

• 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)

ELECTIVE PRACTICAL SUBJECTS – BP809P VAC*

Cleaning Validation

(Practical – BP809P VAC1)

(Perform any 12 Experiments)

1. Preparation of a cleaning validation protocol for a tablet machine
2. Calculation of MACO (Maximum Allowable Carry Over)
3. Swab sampling technique demonstration using stainless steel surface
4. Rinse sampling technique for equipment residue detection
5. Visual inspection for equipment cleanliness (case photos/videos)
6. Preparation of recovery study protocol using a known contaminant
7. Demonstration of Total Organic Carbon (TOC) analysis (video/simulation)
8. HPLC method development for residue analysis (demo dataset)
9. Interpretation of swab analysis results and comparison with acceptance limits
10. Preparation of cleaning log sheet and checklists
11. Validation of cleaning agents: detergent effectiveness and rinsibility
12. Determining dirty hold time and clean hold time experimentally (conceptual)
13. Designing a matrix approach for multi-product equipment
14. Simulated deviation report and CAPA for cleaning failure
15. Preparation of a final cleaning validation summary report

Basic Training in Aseptic Handling Techniques

(Practical – BP809P VAC2)

1. Gown-up / Gown-down Drill – correct sequencing of coverall, hood, mask, goggles, gloves, and sterile boots.
2. Hand-washing Verification – surgical scrub with UV lotion; inspect under UV lamp for missed spots.
3. Clean-room Entry & Flow Simulation – air-shower pass, unidirectional walking, and material air-lock transfer.
4. LAF Hood Preparation – wipe-down with sporicidal, set airflow, place sterile tools in first-air zone.
5. Smoke-pattern Test – visualize HEPA downflow with smoke to confirm laminar, turbulence-free air.
6. Aseptic Liquid Transfer – pipette or syringe transfer of TSB between vials without touching non-sterile surfaces.
7. Sterile Filtration & Filter Integrity Check – filter a buffer through 0.22 µm unit and perform bubble-point test.
8. Mini Media-Fill – fill 20 sterile vials with TSB under LAF, incubate, and record turbidity for 14 days.
9. Environmental & Personnel Monitoring – deploy settle/contact plates, take glove-fingertip prints, run an air sampler.
10. Cleaning & ATP Validation – full hood wipe-down, then ATP swab pre- and post-clean to verify < 200 RLU residue.

Impurity Profiling

(Practical – BP809P VAC3)

(Perform any 12 Experiments)

1. Identification of organic impurities in bulk drugs using TLC
2. Quantification of impurities using HPLC
3. Determination of residual solvents by GC (as per ICH Q3C)
4. UV-spectrophotometric analysis of degradation products
5. Preparation of forced degradation samples (acid/base/hydrolytic)
6. Identification of degradation products via IR spectroscopy
7. Extraction and analysis of impurities from finished dosage forms
8. Impurity profiling of marketed paracetamol tablet using HPLC
9. Qualification of impurities as per ICH Q3A/Q3B guidelines
10. Limit test for heavy metals (as per IP)
11. Estimation of elemental impurities by ICP-MS or simulated method
12. Determination of related substances in antibiotics (e.g., cephalosporins)
13. Use of LC-MS data interpretation for impurity identification (demo/simulated)
14. Impurity profiling of herbal products using HPTLC
15. Report preparation on impurity profiling as per regulatory requirements