BIOSAFETY AND GLP

1. Good Laboratory Practice: Good Laboratory Practice (GLP) is a quality system

concerned with the organisational process and the conditions under which non-clinical
health and environmental safety studies are planned, performed, monitored, recorded,
archived and reported.

2. Study Director’s Responsibilities

1. The Study Director is the single point of study control and has the responsibility for
the overall conduct of the study and for its final report.
2. These responsibilities should include, but not be limited to, the following functions.
The Study Director should:
a) approve the study plan and any amendments to the study plan by dated signature;
b) ensure that the Quality Assurance personnel have a copy of the study plan and any
amendments in a timely manner and communicate effectively with the Quality
Assurance personnel as required during the conduct of the study;
c) ensure that study plans and amendments and Standard Operating Procedures are
available to study personnel;
D) ensure that the procedures specified in the study plan are followed, and assess and
document the impact of any deviations from the study plan on the quality and
integrity of the study,
E) sign and date the final report to indicate acceptance of responsibility for the
validity of the data and to indicate the extent to which the study complies with these
Principles of Good Laboratory Practice;

3. Study Personnel’s Responsibilities

i) Study personnel will have access to the study plan and appropriate Standard
Operating Procedures applicable to their involvement in the study. It is their
responsibility to comply with the instructions given in these documents. Any
deviation from these instructions should be documented and communicated directly to
the Study Director, and/or if appropriate, the Principal Investigator(s).
ii. All study personnel are responsible for recording raw data promptly and accurately
and in compliance with these Principles of Good Laboratory Practice, and are
responsible for the quality of their data.
iii. Study personnel should exercise health precautions to minimise risk to themselves
and to ensure the integrity of the study. They should communicate to the appropriate
person any relevant known health or medical condition in order that they can be
excluded from operations that may affect the study.

4. Content of the Study Plan

The study plan should contain, but not be limited to the following information:
1. Identification of the Study, the Test Item and Reference Item
a) A descriptive title; b) A statement which reveals the nature and purpose of the
study; c) Identification of the test item by code or name (IUPAC; CAS number,
biological parameters, etc.); d) The reference item to be used.
2. Information Concerning the Sponsor and the Test Facility
a) Name and address of the sponsor; b) Name and address of any test facilities and
test sites involved; c) Name and address of the Study Director; d) Name and address
of the Principal Investigator(s), and the phase(s) of the study delegated by the Study
Director and under the responsibility of the Principal Investigator(s).
3. Dates
a) The date of approval of the study plan by signature of the Study Director. The
date of approval of the study plan by signature of the test facility management
and sponsor if required by national regulation or legislation in the country where
the study is being performed. b) The proposed experimental starting and completion
dates.
4. Test Methods
5. Issues (where applicable) a) The justification for selection of the test system;
e) Detailed information on the experimental design, including a description of the
chronological procedure of the study, all methods, materials and conditions, type
and frequency of analysis, measurements, observations and examinations to be
performed, and statistical methods to be used (if any).
6. Records A list of records to be retained
5. Biosafety: Primary containment and Secondary containment

In biosafety, primary containment protects the laboratory and its workers from
biological agents, while secondary containment protects the environment outside the
laboratory:
Primary containment Secondary containment

Purpose Protects laboratory workers and the immediate Protects the environment
laboratory environment outside the laboratory

How it's Good microbiological technique, safety Facility design and

achieved equipment, and personal protective equipment operational procedures

6. Standard Safety Practices in the Microbiology Laboratory

Standard Microbiological Safety Practices
Personal protective equipment
Wear closed-toe shoes, a long-sleeved lab coat, safety glasses or goggles, and
disposable gloves when working with microorganisms or chemicals. Wear a face
shield when there is a risk of splashing.
Laboratory practices
Wash your hands before and after working in the lab. Keep your work area clear of
unnecessary items. Disinfect work surfaces before and after each lab period.
Laboratory environment
Keep the lab locked when not in use. Post biohazard signs near doors and on
equipment. Don't allow children under 12 or pets in the lab.
Laboratory chemicals
Don't ingest any chemicals. Label chemicals with hazard signage. Use a fume hood
when working with chemicals to prevent splashing.
Laboratory procedures
Follow all instructions from your instructor. Report any accidents, spills, or injuries
to your instructor.
Other safety considerations
Don't eat, drink, or chew gum in the lab. Don't apply cosmetics or handle contact
lenses in the lab. Fasten long hair and avoid wearing dangling jewelry or loose
clothing.
Equipment
Report damaged electrical equipment to your instructor. Wear protective ear
coverings when using a sonicator.
7. Biosafety cabinets

The principle of a biosafety cabinet (BSC) is to protect the user and the environment
from biological agents by using air filters and negative pressure to create a barrier:

Airflow
The cabinet creates a vertical airflow that protects the user and sucks air out of the
cabinet to create negative pressure.
Filters
The cabinet uses high-efficiency particulate air (HEPA) filters to trap infectious
agents. The outside air is filtered before entering the cabinet to prevent
contamination of samples, and the air inside the cabinet is filtered before being
released to protect the environment.
Air curtain
The cabinet draws in room air through a front grille to create an air curtain that
protects the user from hazardous aerosols.
Negative pressure
The negative pressure prevents air from spilling back into the lab.
BSCs are a common and effective way to protect people from splashes and aerosols
when working with biological agents

8. Differentiate Bio safety levels -1 and 2

The main difference between Biosafety Level 1 (BSL-1) and Biosafety Level 2 (BSL-
2) is the type of agents used and the level of hazard to personnel and the environment:

BSL-1
Used for work with agents that are unlikely to cause disease in healthy adults, such
as non-pathogenic E. coli. No containment is required, and no safety equipment is
needed.
BSL-2
Used for work with agents that are associated with human disease and pose a
moderate hazard to personnel and the environment. Containment is required, and
safety equipment includes:
Class I or II biosafety cabinets (BSCs)
Lab coats
Gloves
Eye/face protection as needed
In addition to the safety equipment, personnel working at BSL-2 labs must be
proficient in microbiological practices. The principal investigator (PI) is responsible
for ensuring that this proficiency has been demonstrated.
 9. Differentiate Bio safety levels -1 and 2
The principles of biosafety levels 3 and 4 are to prevent exposure to biological
hazards in laboratories by containing biological agents. The highest biosafety level is
BSL-4.

Some principles of biosafety levels 3 and 4 include:

Risk assessment: Identify the hazardous characteristics of an agent, the likelihood of

exposure, and the consequences of infection.
Containment: Use primary containment to protect laboratory workers and the immediate
environment.
Personal protective equipment: Wear appropriate clothing, gloves, gowns, respirators,
face shields, and goggles.
Training: Receive regular training on how to handle biohazards and respond to spills.
Standard operating procedures: Follow detailed procedures for safely working with
biohazards.
Emergency response plans: Have protocols in place for accidental spills or exposure.
Decontamination: Decontaminate all materials before exiting the laboratory.
Isolation: BSL-4 laboratories are often located in a restricted zone or separate building.
Exhaust air: BSL-4 laboratories have a dedicated supply of exhaust air.

10. Standard operating procedures

A Standard Operating Procedure (SOP) is a written document that outlines how to
safely perform experiments or work with hazardous materials in a laboratory. SOPs
are important because they ensure that operations are performed correctly and safely.

Here are some things that SOPs in a laboratory might include:

Handling hazardous materials: How to safely handle hazardous chemicals, including

the amount and concentration to use, how to create the working solution, and what
personal protective equipment to wear
Potential hazards: Information about potential hazards and how to mitigate them
Experimental procedures: Detailed steps for performing an experimental procedure
Critical parameters: The critical parameters to evaluate during the analysis
SOPs are usually developed by laboratory personnel who are most knowledgeable and
involved with the experimental process. They should be kept on the premises where
the activities will take place.