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BP611P VACSemester 61 creditsPractical

VAC Elective — Professional Skills / Process Analytical Technology & Quality by Design (Practical)

Complete unit-wise syllabus for BP611P VAC as per the PCI B.Pharm NEP 2020 curriculum (Semester 6 — AI in Pharma + Analysis + Internship II).

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Course Objectives

  • Develop effective verbal and interpersonal communication skills required for professional environments.
  • Train students in workplace etiquette, interview preparation, and team collaboration.
  • Enhance problem-solving, time management, and critical thinking abilities relevant to professional settings.
  • Promote personal grooming, digital professionalism, and responsible social media etiquette.
  • Prepare students to face professional challenges through experiential learning, role play, and interactive activities.
  • Introduce PAT concepts so students grasp how in-line sensors monitor critical quality attributes (CQAs).

Unit-wise Syllabus

2 Units
1
Option 1: BP611P VAC1 — Professional Skills (30 Hours)30 Hours
  • 1. Self-introduction exercise – verbal and written presentation
  • 2. Resume/CV writing – using current industry formats
  • 3. Mock job interview – panel-based or peer-reviewed
  • 4. Group discussion (GD) – on current healthcare or industry topics
  • 5. Public speaking practice – impromptu and prepared speeches
  • 6. Email etiquette and writing professional emails
  • 7. Time management matrix creation (Eisenhower box)
  • 8. Body language analysis – observe and present feedback
  • 9. Conflict resolution role play – team-based activity
  • 10. Creating a LinkedIn profile and optimizing it professionally
  • 11. Debate session – critical thinking and communication
  • 12. Listening skills test – audio-based task with Q&A
  • 13. Workplace scenario simulation – ethics, teamwork, communication
  • 14. Presentation skills – create and deliver PowerPoint presentations
  • 15. Goal-setting and career mapping – using SMART goals
2
Option 2: BP611P VAC2 — Process Analytical Technology & Quality by Design (30 Hours)30 Hours
  • 1. Identify Critical Quality Attributes (CQAs) – Brainstorm and list five tablet CQAs (hardness, dissolution, etc.) and link each to patient safety or efficacy.
  • 2. Ishikawa (Fish-Bone) Diagram – Draw a cause-and-effect diagram for poor tablet dissolution, categorising factors into Materials, Methods, Machines and Manpower.
  • 3. Blend-Uniformity by NIR Probe – Collect in-line near-infrared spectra during 10 min of blender operation and plot real-time API concentration trends.
  • 4. Moisture Tracking with NIR – Use a portable NIR gun to measure LOD in wet granules every 2 min, stopping when the plot hits the 3 % target.
  • 5. Mini DoE for Granulation – Run a 2² design varying impeller speed and granulation time; measure granule mean size and create main-effects plots.
  • 6. Real-Time Release Test (RTRT) – Set up an at-line NIR hardness prediction model, test 20 tablets, and compare predicted vs. actual hardness.
  • 7. Control Chart of Particle Size (FBRM) – Stream Focused Beam Reflectance data during milling; plot X̄ and R for d₅₀ and decide if the process is in control.
  • 8. Multivariate Calibration Model – Build a partial-least-squares (PLS) model correlating NIR spectra to drug content; report R² and RMSEP.
  • 9. FMEA Risk-Priority Number – Score severity, occurrence and detectability for three high-risk process variables; rank them by RPN and suggest mitigation.
  • 10. PAT Model Verification Batch – Run the optimised process, capture PAT data, and confirm that all CQAs meet specification without end-product testing.

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Recommended Textbooks & References

  1. Soft Skills: Enhancing Employability by Meenakshi Raman & Sangeeta Sharma, Oxford University Press
  2. The 7 Habits of Highly Effective People by Stephen R. Covey, Simon & Schuster
  3. Personality Development and Soft Skills by Barun K. Mitra, Oxford University Press
  4. Effective Technical Communication by M. Ashraf Rizvi, Tata McGraw-Hill Education
  5. The Art of Public Speaking by Stephen E. Lucas, McGraw-Hill Education
  6. 1. Bakeev KA, editor. Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries. 2nd ed. Chichester: Wiley; 2010.
  7. Rathore AS, Winkle H. Quality by Design for Biopharmaceuticals. 2nd ed. Hoboken: Wiley; 2019.
  8. Kourti T, Bakeev K. Process Analytical Technology: Theory and Applications. 1st ed. Oxford: Butterworth-Heinemann; 2022.

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 JurisprudenceBP607T AECAEC Elective — Green Chemistry / Materiovigilance / Scientific Writing / Drug Store Management / Medicinal Plant Cultivation / API SciencesBP608PBiopharmaceutics and Pharmacokinetics (Practical)BP609PPharmaceutical Analysis (Practical)BP610P SECSEC Elective — Computer-Aided Drug Design / Analytical Method Development / Principles of Preclinical Studies (Practical)BP612IInternship II (Mandatory)
BP601T