University of Mumbai Syllabus For Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety: Knowing the Syllabus is very important for the students of Semester 6 (TE Third Year). Shaalaa has also provided a list of topics that every student needs to understand.
The University of Mumbai Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety syllabus for the academic year 2021-2022 is based on the Board's guidelines. Students should read the Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety Syllabus to learn about the subject's subjects and subtopics.
Students will discover the unit names, chapters under each unit, and subtopics under each chapter in the University of Mumbai Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety Syllabus pdf 2021-2022. They will also receive a complete practical syllabus for Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety in addition to this.
University of Mumbai Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety Revised Syllabus
University of Mumbai Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety and their Unit wise marks distribution
University of Mumbai Semester 6 (TE Third Year) Good Laboratory Practices and Process Safety Course Structure 2021-2022 With Marking Scheme
| # | Unit/Topic | Weightage |
|---|---|---|
| 100 | Introduction to GLP | |
| 200 | Quality Standards and Quality Assurances | |
| 300 | Good Manufacturing Practices in Pharmaceutical and Food Industries | |
| 400 | Quality Control | |
| 500 | Biosafety | |
| 600 | Safety and Hazard Analysis Hazards | |
| Total | - |
Syllabus
- Good laboratory practices-Introduction, WHO guidlines on GLP and GMP
- History of Good Laboratory Practices
- Quality assurances in Good Laboratory Practices
- 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)
- 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
- 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)
- 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)
- 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
