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1. Project Information: Basic details including project title, location, department, principal investigator, and assessment date
2. Scope of Assessment: Clear definition of the biological work/research activities being assessed
3. Biological Agent Classification: Identification and classification of biological agents according to risk groups (1-4) as per Indian regulations
4. Hazard Identification: Detailed description of biological hazards, including pathogenicity, transmission routes, and infectious dose
5. Exposure Assessment: Analysis of potential exposure routes and scenarios for workers and environment
6. Risk Evaluation: Determination of risk levels based on likelihood and consequence matrices
7. Control Measures: Existing and proposed control measures including engineering controls, administrative controls, and PPE
8. Emergency Response Procedures: Procedures for handling accidents, spills, and exposure incidents
9. Waste Management: Procedures for handling, decontamination, and disposal of biological waste
10. Training Requirements: Specific training needs for personnel handling biological materials
11. Review and Approval: Sign-off section for relevant authorities including Biosafety Officer and Committee
1. Animal Handling Procedures: Required when assessment involves work with laboratory animals
2. GMO Risk Assessment: Required for work involving genetically modified organisms
3. Environmental Impact Assessment: Required for activities with potential environmental release risks
4. Transport Procedures: Required when biological materials need to be transported between facilities
5. Medical Surveillance: Required for high-risk biological agents requiring specific health monitoring
6. Research-Specific Protocols: Required for novel or specialized research procedures
1. Appendix A - Risk Matrix: Standard risk assessment matrices for biological hazards
2. Appendix B - PPE Requirements: Detailed PPE specifications for different risk levels and activities
3. Appendix C - Decontamination Procedures: Specific procedures for different types of decontamination
4. Appendix D - Emergency Contact Information: List of emergency contacts and response team members
5. Appendix E - Biological Agent Data Sheets: Detailed information about specific biological agents used
6. Appendix F - Incident Report Forms: Standard forms for reporting accidents and incidents
7. Schedule 1 - Laboratory Biosafety Levels: Specifications and requirements for different biosafety levels
8. Schedule 2 - Equipment Certification Records: Documentation of safety equipment certification and maintenance
Risk Group
Containment Level
Biosafety Level (BSL)
Personal Protective Equipment (PPE)
Biological Hazard
Exposure
Decontamination
Sterilization
Infectious Material
Pathogen
Host
Vector
Culture
Sharps
Aerosol
Biohazardous Waste
Universal Precautions
Laboratory-Acquired Infection
Containment Device
Biological Safety Cabinet
Risk Assessment
Control Measures
Standard Operating Procedure (SOP)
Good Laboratory Practice (GLP)
Institutional Biosafety Committee (IBC)
Primary Containment
Secondary Containment
Disinfection
Validated Method
Recombinant DNA
Genetically Modified Organism (GMO)
Zoonotic Disease
Infectious Dose
Transmission Route
Engineering Controls
Administrative Controls
Medical Surveillance
Biosecurity
Emergency Response Protocol
Scope Definition
Risk Classification
Hazard Identification
Exposure Assessment
Risk Evaluation
Control Measures
Emergency Procedures
Waste Management
Training Requirements
Health Surveillance
Documentation Requirements
Compliance Standards
Review and Approval
Safety Protocols
Equipment Requirements
Facility Requirements
Personnel Requirements
Reporting Obligations
Inspection Procedures
Decontamination Procedures
Transport Protocols
Storage Requirements
Access Control
Record Keeping
Incident Response
Environmental Protection
Quality Assurance
Biosecurity Measures
Certification Requirements
Healthcare
Biotechnology
Pharmaceutical
Research and Development
Academic Institutions
Clinical Laboratories
Agriculture
Food and Beverage
Environmental Services
Waste Management
Public Health
Veterinary Sciences
Research and Development
Quality Assurance
Environmental Health and Safety
Laboratory Operations
Facilities Management
Biosafety
Risk Management
Compliance
Clinical Operations
Scientific Operations
Laboratory Technician
Research Scientist
Biosafety Officer
Principal Investigator
Quality Assurance Manager
Environmental Health and Safety Manager
Laboratory Manager
Research Director
Biological Safety Cabinet Certifier
Facility Manager
Clinical Laboratory Supervisor
Microbiologist
Biotechnology Researcher
Safety Compliance Officer
Risk Assessment Specialist
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