Industrial Pharmacy and Facility Design
Pharmaceutical manufacturing and plant design; production management; scale-up, quality systems and regulatory facility requirements.
Shree Sai Prakashan is writing a full set of B.Pharm titles to this new NEP 2020 syllabus. Get notified the moment the book for this subject is released, or pre-book sets for your college.
Course contents — unit by unit · PCI NEP 2020 BP803T
Unit 1 · Regulatory Guidelines for Formulation Development 12 hrs
The regulatory guidelines governing formulation development; ICH Q8 and Quality by Design — the fundamental terminology, the process and the tools of optimization; and the application of QbD principles to pharmaceutical product development.
Unit 2 · Stability Testing 9 hrs
The ICH guidelines on stability testing; stability protocols, storage conditions and climatic zones; accelerated and long-term studies; and shelf-life determination and the assignment of expiry dates.
Unit 3 · Industrial Aspects of Product Development 9 hrs
The industrial aspects of product development; and pilot-plant and scale-up studies — the general considerations, the significance of scale-up, and the scale-up of solid, liquid and semisolid dosage forms.
Unit 4 · Technology Development and Transfer 9 hrs
Technology development and transfer; the WHO guidelines on technology transfer — terminology, the technology-transfer protocol and documentation; and the transfer of process and analytical methods between sites.
Unit 5 · Technology Transfer Agencies and Facility Design 6 hrs
The technology-transfer agencies operating in India — APCTD, NRDC, TIFAC, BCIL and TBSE/SIDBI; and pharmaceutical facility design, plant layout and the regulatory requirements governing manufacturing premises.
← Full B.Pharm Fourth Year syllabus All 8 semesters — B.Pharm NEP 2020 syllabus →
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