Good Laboratory Practices and Process Safety Semester 6 (TE Third Year) BE Biotechnology University of Mumbai Topics and Syllabus

CBCGS [2018 - current]
CBGS [2014 - 2017]
Old [2000 - 2013]


100 Introduction to GLP
  • Good laboratory practices-Introduction, WHO guidlines on GLP and GMP
  • History of Good Laboratory Practices
  • Quality assurances in Good Laboratory Practices
200 Quality Standards and Quality Assurances
  • Quality Standards- Advantages and Disadvantages, Concept of Quality Control
  • Quality Assurance- Their functions and advantages
  • Quality assurance and quality management in industry
  • Customer requirement of quality
  • Government and trade standards of quality Federal Food and Drug Law FDA Action BSTI Laws, BSTI action and activities Other food laws (Legalization)
  • Trade and Company Standards Control by National, International, Social Organizations (example:FAO, WHO, UNICEF, CAB), Society (example: NSB, Professional societies)
300 Good Manufacturing Practices in Pharmaceutical and Food Industries
  • Types of validation in Pharma industry
  • Scope and importance of Validation
  • Limitations
  • Organization and Elements of validation (Q, OQ, PQ and DQ) Cleaning Validation
  • Validation of Analytical Procedures as per ICH Guidelines Implications of cGMP and Food plant sanitation
  • The regulations of cGMPs Planning of Plant Sanitation Programs and Construction factors Hygeinic design of food plants and equipments Sanitation in warehousing, storage, shipping, receiving, containers and packaging materials Control of rats, rodents, birds, insects and microbes.
  • Cleaning and Disinfection: Physical and Microbiological Approach
400 Quality Control
  • Introdution to Quality control and Total Quality Control in the food industry
  • Various Quality Attributes of food such as size, shape, texture, color, viscosity and flavor
  • Instrumental, chemical and microbial quality control
  • Sensory evaluation of food and statistical analysis
  • Food Regulation and Compliance
  • Food Inspection and Food Law
  • Critical Control Points in Food Industries: Critical Quality control point in different stages of production including raw materials and processing materials
  • Food Quality and Quality control including the HACCP system (Critical quality control points in different stages of production including raw materials and proccessing materials)
500 Biosafety
  • Introduction: Historical Background, Biosafety in Laboratory/ institution.
  • Laboratory associated infections and other hazards
  • Assessment of Biological Hazards and levels of biosafety
  • Prudent biosafety practices in the laboratory/institution Introduction to Biological safety cabinets
  • Primary Containment of Biohazards, Biosafety Levels
  • Recommended Biosafety Levels for Infectious Agents and Infected Animals Biosafet guidelines
  • Government of India Guidelines, Definition of Genetically Modified Organisms (GMOs)
600 Safety and Hazard Analysis Hazards
  • Chemical Hazards Classification, Radiation hazards and control of exposure to radiation Fire triangle, fire prevention methods
  • Industrial hygiene: Introduction, evaluation and control Toxicology: Routes of entry of toxic substances, Toxic studies Safe Housekeeping instrumentation for safe operation, personal protective equipments

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