UNIQUE SERIES AKTU Syllabus
BP611P VAC2

Process Analytical Technology (PAT) and QbD in Formulation Science (Practical)

L-T-P0-0-2 Session2026-27 TypeLab / Practical
Appears in 1 semester

B.Pharm · Sem 6 (VAC – Elective 5)

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List of Experiments / Activities

  1. Process Analytical Technology (PAT) and QbD in Formulation Science (Practical) Elective Credit Hours Per Week (L-T-P) Max. Hours L T P
  2. 1-- --
  3. 30Maximum Marks SE ESE
  4. 1Identify Critical Quality Attributes (CQAs) Brainstorm and list five tablet CQAs (hardness, dissolution, etc.) and link each to patient safety or efficacy.
  5. 2Ishikawa (Fish-Bone) Diagram Draw a cause-and-effect diagram for poor tablet dissolution, categorising factors into Materials, Methods, Machines and Manpower.
  6. 3Blend-Uniformity by NIR Probe Collect in-line near-infrared spectra during 10 min of blender operation and plot real-time API concentration trends.
  7. 4Moisture 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.
  8. 5Mini DoE for Granulation Run a 2² design varying impeller speed and granulation time; measure granule mean size and create main-effects plots.
  9. 6Real-Time Release Test (RTRT) Set up an at-line NIR hardness prediction model, test 20 tablets, and compare predicted vs. actual hardness.
  10. 7Control Chart of Particle Size (FBRM) Stream Focused Beam Reflectance data during milling; plot
  11. 8Multivariate Calibration Model Build a partial-least-squares (PLS) model correlating NIR spectra to drug content; report R² and RMSEP.
  12. 9FMEA Risk-Priority Number Score severity, occurrence and detectability for three high-risk process variables; rank them by RPN and suggest mitigation.
  13. 10PAT Model Verification Batch Run the optimised process, capture PAT data, and confirm that all CQAs meet specification without end-product testing.
Course Objectives6 points
  • The objectives of this course are to:
  • Introduce PAT concepts so students grasp how in-line sensors monitor critical quality attributes (CQAs).
  • Explain QbD thinking for defining design space, critical process parameters (CPPs), and risk-based control strategies.
  • Teach basic PAT tools near-infrared (NIR) probes, focused-beam reflectance (FBRM), and multivariate models.
  • Demonstrate mini-DoE methods that link process variables to CQAs and support real-time release testing (RTRT).
  • Instil risk-analysis skills using Ishikawa diagrams and FMEA to prioritise and mitigate formulation hazards.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Describe the role of PAT and QbD in ensuring consistent product quality throughout a formulation process.
  2. CO2Identify and justify key CQAs, CPPs, and potential failure modes for a solid-dosage product.
  3. CO3Collect and interpret real-time data from an NIR or FBRM sensor and decide when a blend or granulation meets targets.
  4. CO4Design and analyse a small factorial experiment that optimises at least one CQA within a defined design space.
  5. CO5Prepare a brief risk-control plan showing ranked RPN values and proposed PAT-based monitoring to enable RTRT.
Recommended References (Preferably latest edition):4 books
  1. Bakeev KA, editor. Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries. 2nd ed. Chichester: Wiley; 2010.
  2. Rathore AS, Winkle H. Quality by Design for Biopharmaceuticals. 2nd ed. Hoboken: Wiley; 2019.
  3. Kourti T, Bakeev K. Process Analytical Technology: Theory and Applications. 1st ed. Oxford: Butterworth-Heinemann; 2022.
  4. Patil AS, Rane VP. Practical Implementation of Quality by Design (QbD) for Pharmaceutical Product Development. 1st ed. Amsterdam: Elsevier; 2019. SEMESTER VII Course Title Course Type

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Official AKTU syllabus

This subject is on page 256, 257, 258 of the original AKTU PDF.

Official AKTU syllabus PDF ↗