BP803TSemester 83 creditsTheory
Industrial Pharmacy and Facility Design
Complete unit-wise syllabus for BP803T as per the PCI B.Pharm NEP 2020 curriculum (Semester 8 — AI Ethics + Clinical + Final Research).
URL:
https://pharmacode.vercel.app/syllabus/semester-8/bp803t-industrial-pharmacy-and-facility-design/Unit-wise Syllabus
5 Units1
Industrial Pharmaceutical Manufacturing9 Hours- Industrial pharmaceutical manufacturing: batch vs. continuous manufacturing; manufacturing process design; scale-up considerations (mixing, heat transfer, granulation)
- Technology transfer: scale-up from lab to pilot to commercial batch; tech transfer protocol; process characterisation; comparability studies; manufacturing site changes under regulatory submissions
- Lean manufacturing: value stream mapping, waste elimination (7 wastes); Six Sigma in pharma manufacturing; OEE (Overall Equipment Effectiveness) calculation
2
Facility Layout and Design9 Hours- Pharmaceutical facility design principles: zone classification (AHU zones), traffic flow (personnel, material, waste), cross-contamination prevention, unidirectional flow
- Clean room design: ISO classification (5-8); materials for construction (cGMP-compliant surfaces, coving); cleanroom monitoring plan (particle counts, microbial monitoring)
- Facility master plan: site selection criteria; segregation requirements for penicillin/cephalosporin/hormones/cytotoxics; biological safety levels
3
HVAC Systems and Clean Room Technology9 Hours- HVAC system components: Air Handling Units (AHU), HEPA filters (H13, H14), pre-filters, chilled water coils, supply and return air ducts, fan motor systems
- Pressure differentials and air change rates for different ISO classes; temperature and humidity control; smoke studies for airflow visualisation
- HVAC qualification: DQ, IQ, OQ, PQ of HVAC; re-qualification frequency; HVAC monitoring systems; WHO TRS 957 Annex 2 HVAC guidelines
4
Equipment Qualification9 Hours- Qualification stages: User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Calibration: traceability to national standards; calibration frequency; calibration certificates; out-of-calibration actions; 21 CFR Part 11 for computerised systems
- Critical equipment qualification examples: autoclave (steam sterilizer), depyrogenation tunnel, tablet press, capsule filler, freeze dryer — key qualification parameters and acceptance criteria
5
Environmental and Safety Management9 Hours- Environmental monitoring programme: viable and non-viable particle monitoring; sampling locations, frequency, alert and action limits per EU GMP Annex 1 (2022 revision)
- Industrial safety in pharma: OSHA standards; hazard identification (HAZID, HAZOP); personal protective equipment (PPE); handling of cytotoxic, hormonal, highly potent API (HPAPI)
- Effluent treatment and waste management: pharmaceutical effluent treatment plant (ETP); biomedical waste rules; green pharmacy principles; sustainability in pharmaceutical manufacturing
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What's coming next on this page
- Reference textbooks and recommended reading list
- Previous year question papers (PYQ)
- Topic-wise short notes and revision summaries
- Suggested external resources and video tutorials
Other subjects in Semester 8
BP801TEthical Considerations and Translational Applications of AI in PharmacyBP802TClinical PharmacotherapeuticsBP804TPharmaceutical ManagementBP805TSterile Dosage Forms and Novel Drug Delivery SystemBP806T AECAEC Elective (Pharma Packaging / Supply Chain / Industrial Safety / Traditional Healing / AR-VR Pharma 4.0 / Herbal Cosmetics)BP807P + BP808PPracticals — Pharmaceutical Marketing Skills + Sterile Dosage Forms + VAC ElectiveBP810RPResearch Project (Final Submission)