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BP505TSemester 53 creditsTheory

Pharmaceutical Quality Assurance

Complete unit-wise syllabus for BP505T as per the PCI B.Pharm NEP 2020 curriculum (Semester 5 — QA + Innovation + Drug Delivery).

All Sem 5 Subjects
URL:https://pharmacode.in/syllabus/semester-5/bp505t-pharmaceutical-quality-assurance/

Unit-wise Syllabus

5 Units
1
Quality Concepts and Quality by Design (QbD)9 Hours
  • Quality concepts: definition, total quality management (TQM); quality circles; cost of quality; quality planning, control, and improvement
  • ICH Q8 Pharmaceutical Development: design space; Quality by Design (QbD) approach; Quality Target Product Profile (QTPP); Critical Quality Attributes (CQAs); Critical Process Parameters (CPPs)
  • Risk management: ICH Q9 guidelines; Failure Mode and Effects Analysis (FMEA); fault tree analysis; risk assessment tools in pharmaceutical development
2
Good Manufacturing Practice (GMP)9 Hours
  • Schedule M (India): premises, equipment, materials, documentation, QC requirements; Revised Schedule M 2023 updates
  • WHO GMP guidelines: basic principles; GMP for sterile pharmaceutical products; GMP for biological products
  • ICH Q7 GMP for Active Pharmaceutical Ingredients: key requirements; impurity control; qualification of starting materials
3
Validation9 Hours
  • Process validation: stages (design, qualification, continued process verification); validation master plan; validation protocols and reports
  • Analytical method validation: ICH Q2(R1) parameters — specificity, linearity, range, accuracy, precision (repeatability, intermediate precision, reproducibility), detection limit, quantitation limit, robustness
  • Cleaning validation: acceptance criteria (MACO calculation, visual inspection, swab sampling, rinse sampling); cleaning validation protocols
4
Audits and Documentation9 Hours
  • Internal audits: planning, checklists, audit reports, CAPAs; vendor qualification: supplier audits, approved vendor list
  • Documentation in pharmaceutical QA: good documentation practices (GDocP); master batch record (MBR); batch production record (BPR); standard operating procedures (SOPs); change control
  • Deviation and out-of-specification (OOS) management: deviation classification, root cause analysis, CAPA system
5
ICH Guidelines and Stability Studies9 Hours
  • ICH guidelines overview: Q1A-Q1F (stability), Q2 (analytical method validation), Q3 (impurities), Q8 (pharmaceutical development), Q10 (pharmaceutical quality system)
  • Stability studies: ICH Q1A (accelerated, long-term, intermediate conditions); climatic zones; stress testing; shelf life determination; ongoing stability programs
  • Pharmaceutical quality system: ICH Q10; continual improvement; product lifecycle management; knowledge management

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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
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Other subjects in Semester 5

BP501TBiomedicinal ChemistryBP502TIndustrial PharmacognosyBP503TInnovation and Startup EcosystemBP504TPharmaceutical Dosage Form IIBP506TSystemic Pharmacology IIBP507PBiomedicinal Chemistry (Practical)BP508PIndustrial Pharmacognosy (Practical)BP509PPharmaceutical Dosage Form II (Practical)BP510PSystemic Pharmacology II (Practical)
BP504TBP506T