BT25404 Introduction to Standards in Biotechnology – Semester IV – Biotech – R-2025

Subject Code & Name: BT25404 – Introduction to Standards in Biotechnology

Regulation: R-2025

Semester: IV (Fourth Semester)

Branch: B.Tech. Biotechnology (Biotech)

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

Course Objectives

• To develop competency in regulatory affairs, GMP standards, and quality compliance essential for biotechnology product development and manufacturing.

Full Unit-wise Syllabus

Unit I – Biotech Regulatory Frameworks and GMP

FDA biologics regulations (21 CFR 600-680), EMA ATMP guidelines, ICH Q7-Q12. WHO GMP for biologics, ISO 14644 cleanroom standards.

Activities: Demonstration of FDA regulations and guidelines

Unit II – Bioprocess Validation and Quality Standards

QbD (ICH Q8), process validation (IQ/OQ/PQ) for fermenters, ISO 15378 sterile manufacturing. Risk management (ICH Q9 FMEA), deviation/CAPA systems, biotech-specific documentation (batch records).

Activities: Demonstration of ISO standards

Unit III – Inspections, Approvals and Surveillance

BLA/IND/MAA submissions, GMP inspections (FDA Form 483, EMA GMP certificates). Post-approval changes (ICH Q12), change control (LMTD/CPV), biotech surveillance for cell/gene therapies.

Activities: Demonstration of GMP standards

Course Outcomes (COs)

• CO1: Explain biotechnology industry standards and GMP requirements for biologics manufacturing.
• CO2: Apply validation and quality compliance protocols specific to bioprocesses.

Assessment Pattern (Quick Note)

• Weightage: Continuous Assessment 40% | End Semester Examinations 60%
• Internal methodology: Quiz (20%), Assignments (30%) and Internal Examinations (50%)

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