BP708T AECSemester 71 creditsTheory
AEC Elective — Current Good Manufacturing Practices / Pharmaceutical Automation / Cellular Biology / Medical Devices / Food Waste Products / Biosimilars
Complete unit-wise syllabus for BP708T AEC as per the PCI B.Pharm NEP 2020 curriculum (Semester 7 — Pharmacovigilance + Regulatory + Research).
URL:
https://pharmacode.vercel.app/syllabus/semester-7/bp708t-aec-aec-elective-current-good-manufacturing-practices-pharmaceutical-automation-cellular-biology-medical-devices/Course Objectives
- Explain the structure, purpose, and implementation of Standard Operating Procedures (SOPs) in pharmaceutical operations.
- Develop understanding of training and development systems, including training needs assessment and evaluation methods used in the pharmaceutical industry.
- Describe the principles of current Good Manufacturing Practices (cGMP) and key regulatory guidelines relevant to pharmaceutical quality assurance.
- Examine core pharmaceutical quality systems such as Quality Management Systems (QMS), CAPA, deviation management, and non-conformance handling.
- Understand procedures for managing customer complaints, investigating quality issues, and ensuring product safety and regulatory compliance.
- Introduce the fundamental concepts of automation technologies used in the pharmaceutical industry.
Unit-wise Syllabus
6 Units1
Option 1: BP708T AEC1 — Current Good Manufacturing Practices (cGMP) (15 Hours)15 Hours- Standard Operating Procedures (SOP), Systems for Training & Development in Pharmaceuticals
- Introduction to SOPs, SOP on SOP, Contents of a standard SOP, Writing a good SOP, Distribution and control of SOPs.
- Introduction to Training and development, Training needs identification, Training and evaluation. A comprehensive review of cGMP and various important FDA guidelines
- List of major guidelines referred in pharmaceuticals
- Effectively reading and understanding the guidelines Important Quality Assurance and cGMP systems adopted in Pharmaceuticals
- Introduction to Quality Management Systems (QMS), Manufacturing Assurance, Analytical Assurance, Developments Quality Assurance, Engineering Assurance.
- Concepts of corrective and preventive actions (CAPA), Deviations and Incidents handling. Handling of non-conforming materials Handling of Customer Complaints
- Introduction to complaints, Types of complaints
- Understanding Manufacturing defects and Quality issues
- Handling and investigation of customer complaints Regulatory Audits
- Introduction to audits and Types of audits.
- Preparation for a successful audit, Audit teams and internal audits.
- Handling of FDA inspections: FDA observations, Compliance and replying to an audit report.
2
Option 2: BP708T AEC2 — Pharmaceutical Automation (15 Hours)15 Hours- Introduction to Automation in Pharmaceuticals
- Definition and scope of automation in pharmaceutical industry
- Importance and benefits: accuracy, efficiency, cost-effectiveness, compliance
- Types of automation: fixed, programmable, flexible
- Application areas: production, packaging, quality control, warehousing
- Challenges and limitations of automation Automated Manufacturing Systems
- Principles of automated tablet compression, capsule filling, liquid filling, and coating machines
- PLC-based machinery in granulation and drying
- Robotics in sterile product manufacturing (isolators, RABS)
- Continuous manufacturing vs. batch processing
- Automation in aseptic processing and lyophilization Process Control and Instrumentation
- Sensors and transducers: temperature, pressure, flow, pH, conductivity
- Introduction to SCADA (Supervisory Control and Data Acquisition) systems
- Distributed Control Systems (DCS) in pharma
- Process Analytical Technology (PAT) – definition and applications
- Basics of automation programming (ladder diagrams, logic gates – overview only) Quality Control and Laboratory Automation
- Automation in analytical laboratories: HPLC, UV, FTIR, dissolution testers
- Laboratory Information Management System (LIMS)
- Integration of instruments with software and data loggers
- Automated sampling and testing methods
- Role of AI/ML in predictive quality assurance Regulatory Aspects and Emerging Trends
- Regulatory expectations: USFDA, WHO, EMA on automation & electronic systems
- 21 CFR Part 11 – electronic records and signatures
- Data integrity and ALCOA
- Emerging trends: IoT, Industry 4.0, cloud-based manufacturing, AI in pharma
- Case studies: automated systems in top pharma companies
3
Option 3: BP708T AEC3 — Modern Techniques in Cellular Biology (15 Hours)15 Hours- CRISPR & Genome Editing CRISPR-Cas9 mechanics, guide-RNA design and DNA repair outcomes, contrasts knock-outs, knock-ins and base-editing, and shows how dCas9 fusions enable gene activation or repression. Students compare delivery routes—plasmid, ribonucleoprotein, viral and lipid-nanoparticle—then evaluate off-target detection strategies before a mini-lab in which they design a gRNA and screen predicted off-targets. Flow Cytometry & Cell Sorting Learners review flow-cytometer fluidics, optics and fluorochrome chemistry, interpret forward/side scatter plots for cell size and granularity, and build multi-colour antibody panels with compensation. They perform cell-cycle, apoptosis and immunophenotyping assays, study FACS sorting logic and viability checks, and finish with a hands-on run of a four-colour immunophenotyping panel. Live-Cell Imaging This unit covers phase-contrast, DIC and fluorescence time-lapse microscopy, stressing environmental control through on-stage incubators and microfluidic perfusion. Students deploy fluorescent reporters such as GFP fusions and calcium biosensors to track motility, division and signalling, learn to minimise phototoxicity and manage large image datasets, then conduct a 12-hour GFP-cell time-lapse demo. Single-Cell RNA-Seq & Multi-Omics Participants examine single-cell isolation by droplets, microwells or FACS, walk through barcoding, library preparation and sequencing, and run a basic bioinformatics pipeline for quality control, normalisation, clustering and UMAP/t-SNE visualisation. They identify cell types, trajectories and rare populations, glimpse CITE-seq and spatial transcriptomics, and explore a public scRNA-seq dataset in R/Python during a workshop. Advanced Fluorescence & Super-Resolution Microscopy Confocal and two-photon fundamentals, followed by super-resolution strategies—STED, SIM and PALM/STORM—plus functional techniques such as FRET, FRAP and FLIM for probing protein interactions and dynamics. Learners plan multiplexed staining with spectral imaging, discuss clinical applications including FISH and diagnostic immunofluorescence, and acquire and process a confocal z-stack in a practical sessions.
4
Option 4: BP708T AEC4 — Medical Devices (15 Hours)15 Hours- Introduction to Medical Devices: History and Overview of Medical Device Industry and evolving market Trends
- (India + WW)
- GOI’s initiatives and National Medical Device Policy.
- Regulatory frameworks (CDSCO; State FDA; USFDA; EU-CE, etc.)
- Medical device design and development process
- Definition and Classification of Medical Devices (India; US; EU) Medical Device Design, Biomaterials and Biocompatibility:
- Medical Device Design principles and methodologies, safety analysis
- Properties and selection of materials &
- biomaterials for devices
- Tissue engineering and regenerative medicine
- Biocompatibility Testing and Standards (ISO 10993) Manufacturing and Quality Systems: (based on ISO 13485 Fifth Sch of IMDR 2017)
- Good Manufacturing Practices (GMP) &
- Infrastructure requirements
- Quality assurance and quality control in Medical Devices
- Supply chain management (warehousing distribution)
- Risk Management (ISO 14971) Regulatory Affairs, Regulatory strategies for global market access
- Medical device regulations and standards (IMDR 2017)
- Understanding Regional Differences in Regulatory Pathways
- Regulatory submissions and approvals (India)
- Post-market surveillance and vigilance (India)
- Global Regulatory Requirements (USFDA, CE Mark, etc.)
- Case Studies of Global Regulatory Challenges Biomedical Engineering
- Instrumentation: Emerging Technologies
- Principles of biomedical sensors and transducers
- Medical imaging techniques (X-ray, CT, MRI, ultrasound)
- Telemedicine and remote monitoring
- Integration of Electronics and Software in Medical Devices
- Wearable Devices and Remote Monitoring
- Ethical issues in device development and use
5
Option 5: BP708T AEC5 — Transformation of Food Waste into Medicinal Products (15 Hours)15 Hours- Introduction to Food Waste Food waste: Definition, Types, Sources, Causes, Problems, Impacts Advantages, Challenges, Solutions and Future directions Indian and International regulations for food waste management Sustainable Management of Food Waste Principles of Food waste Management Technologies and Processes: Thermo-chemical Processes, Biological Processes, Green extraction, Pyrolytic and Enzymatic techniques Byproducts from Food Waste Production of Biohydrogen, Biogas, Organic acids, Vermicompost, and Biopolymers Bioactive Compounds from Food Waste Antimicrobial, Antioxidants, Anti-inflammatory agents, Antibiotics, Prebiotics, Nutritional Supplements, Cosmetics and Biopolymers 3D printed medicines: Customized dosages and Scaffolds Role of AI in Food waste management Machine learning, Internet of Things (IoT) and Blockchain
6
Option 6: BP708T AEC6 — Biosimilars, Vaccines & Macromolecules (15 Hours)15 Hours- Introduction to Biosimilars, Vaccines and Macromolecules
- Classes: Monoclonal antibodies (mAbs), cytokines, insulin, growth factors
- primary/secondary/tertiary structures.
- Biosimilars: Definition, rationale, types (e.g., erythropoietin, filgrastim).
- Vaccines: Generations (live, subunit, viral vector, mRNA)
- adjuvants and delivery systems.
- Industry landscape: Blockbuster biologics (Humira, Keytruda), Indian biosimilar market. Characterization Methodologies
- Physicochemical: SDS-PAGE, SEC-HPLC, peptide mapping, mass spectrometry.
- Glycosylation analysis: N-linked glycans (HILIC, lectin arrays).
- Functional assays: Cell-based potency, binding ELISA, ADCC.
- Comparability for biosimilars: Fingerprinting (ICH Q5E). Manufacturing Protocols
- Upstream: Cell line development (CHO, HEK), bioreactors, media optimization.
- Downstream: Harvesting, chromatography (affinity, ion-exchange), viral clearance.
- Fill-finish: Lyophilization, aseptic processing, cold chain.
- Process analytical technology (PAT) in biologics. Quality Control and Stability Protocols
- Release testing: Host cell proteins (HCP), DNA, sterility, endotoxin (LAL).
- Stability: ICH Q5C for biologics
- subvisible particles, aggregation.
- Immunogenicity assessment: ADA assays, neutralizing antibodies.
- Vaccine QC: Potency, identity, safety (animal models). Regulatory Compliances and Case Studies
- Global: USFDA 351(k) biosimilar pathway, EMA guidelines, WHO prequalification.
- India: CDSCO Biosimilar Guidelines 2021, DCGI vaccine approvals.
- Documentation: BLA/CMC modules, PK/PD comparability studies.
- Case studies: COVID-19 mRNA vaccines (Pfizer), Indian trastuzumab biosimilars.
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Recommended Textbooks & References
- 1. Good Manufacturing Practices for Pharmaceuticals – Joseph D. Nally, CRC Press
- Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials (Vol. 1 & 2) – World Health Organization (WHO), WHO Press
- Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP s – U.S. FDA, CDER/CDRH Guidance Document
- Pharmaceutical Production and Packaging Technologies – Michael J. Groves, CRC Press
- Pharmaceutical Quality by Design: A Practical Approach – Walkiria S. Schlindwein & Mark Gibson, Wiley
- Government of India, Ministry of Health and Family Welfare (2023) Drugs and Cosmetics Rules, 1945: Amendment introducing revised Schedule M – Good Manufacturing Practices. Gazette of India, Notification G.S.R. 922(E), 28 December.
- 1. Automation and Control in the Pharmaceutical Industry by Burton H. Sage, CRC Press
- Pharmaceutical Engineering by K. Sambamurthy, New Age International Publishers
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- Previous year question papers (PYQ)
- Topic-wise short notes and revision summaries
- MCQs and self-assessment quizzes
- Suggested external resources and video tutorials