PY25406 Introduction to Standards in Pharmaceutical Technology – Semester IV – Pharma – R-2025

Subject Code & Name: PY25406 – Introduction to Standards in Pharmaceutical Technology

Regulation: R-2025

Semester: IV (Fourth Semester)

Branch: B.Tech. Pharmaceutical Technology (Pharma)

Credits / L-T-P: 1 Credit | L-T-P: 1-0-0

Course Objectives

• To provide hands-on exposure to pharmaceutical industry practices including manufacturing, quality systems, regulatory compliance, R&D, and industrial management.

Full Unit-wise Syllabus

Unit I – Strategic Value of Standards

Scientific significance of pharmacopoeial standards in ensuring identity, strength, quality, and purity of medicines. Role of USP public standards in establishing global quality benchmarks. Economic impact of standards in reducing drug development costs, facilitating generic drug entry, and minimizing information asymmetry in pharmaceutical supply chains. Principles of reference standard management, including characterization, stability, storage conditions, and usage of primary and working standards.

Activities: Case study discussion on pharmacopeial standards in global pharmaceutical trade. (e.g., ethylene glycol tragedy); Identification of reference standard labels and certificates. Group discussion on economic benefits of standardization in generic drug development.

Unit II – Global Pharmacopoeias and Monograph Design

Overview of major pharmacopoeias including Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and the International Pharmacopoeia. Structure and components of pharmacopoeial monographs, including identification tests, impurity profiling (organic, inorganic, residual solvents), and assay methods. Role of the Pharmacopoeial Discussion Group (PDG) in harmonizing global testing standards.

Activities: Analysis of a sample drug monograph from IP/USP. Comparative study of assay methods a single component drug by UV/HPLC. Student presentation on global pharmacopoeial harmonization initiatives.

Unit III – GxP Compliance

Concept of the GxP framework, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP). Role of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in harmonizing global pharmaceutical inspections. Quality system requirements based on WHO Technical Report Series (TRS) guidelines and ICH Q9 quality risk management. Importance of site master files and inspection readiness.

Activities: Preparation of a Site Master File outline. Simulation exercise on pharmaceutical inspection readiness. Group discussion on GMP compliance failures and regulatory actions.

Unit IV – Digital Standards and System Validation

Regulatory requirements for digital compliance, including 21 CFR Part 11 and EU GMP Annex 11. Principles of data integrity (ALCOA+). Validation of computerized systems using the GAMP-5 V-model approach. Conduct of quality audits, identification of non-conformances, and implementation of Corrective and Preventive Actions (CAPA).

Activities: Case analysis of data integrity violations in pharmaceutical companies. Demonstration of ALCOA+ principles in laboratory documentation. Audit simulation identifying non-conformances and CAPA planning.

Course Outcomes (COs)

• CO1: Mapping Mapping Understand pharmaceutical standards and their significance in ensuring drug quality, safety, and regulatory compliance.
• CO2: Analyze pharmacopoeial monographs, reference standards, and regulatory requirements for pharmaceutical products.
• CO3: Evaluate GxP practices, quality systems, and digital regulatory frameworks for compliance in pharmaceutical industries.

Assessment Pattern (Quick Note)

• Weightage: Continuous Assessment 60% | End Semester Examinations 40%
• Internal methodology: Continuous Assessment (40%) • Quiz / MCQ test on pharmacopoeial standards – 10% • Assignment / case study analysis – 10% • Activity-based presentation (monograph/GMP audit simulation) – 10% • Internal test – 10% • End Semester Examination (60%)

Source: Official Anna University – B.Tech. Pharmaceutical Technology R-2025 Syllabus
Last Updated: October 2026