BIOSAFETY PROGRAM

MANAGEMENT (1)

LECTURE – 2
BS BIOTECHNOLOGY
BATCH – 1, SEMESTER – VI
DR. NIDA DASTAGIR

DOW COLLEGE OF BIOTECHNOLOGY

DOW UNIVERSITY OF HEALTH SCIENCES
CONTENTS

 Good Laboratory Practices (GLP)

 Standard Operating Procedures (SOPs),
 Biosafety program management
 Policy,
 Planning
 Legal requirements,
 Training

 Safety Data Sheets (SDS)

 GOOD LABORATORY PRACTICES (GLP)
 Good Laboratory Practice (GLP) embodies a set of
principles that provides a framework within which
laboratory studies are planned, performed, monitored,
recorded, archived and reported.
 GLP applies to non clinical studies conducted for the
assessment of the safety or efficacy of chemicals
(including pharmaceuticals).
 GLP certify that every step of the analysis is valid or
not.
 It assures the quality and integrity of the data.
WHY WAS GLP CREATED?

 FDA performed in depth investigations on 40

toxicology labs
 They observed a lot fraudulent activities and poor
lab practices
 Famous example, Industrial Bio-test Lab
BASIC PRINCIPLES OF GLP
STANDARD OPERATING PROCEDURES (SOPS)

 A document explains how to perform a certain activity.

 It assures that a certain quality of a procedure is maintained.
 Helpful in many workplaces which require firm procedures or observance a set of
instructions
 Serve as a good reference to employees who are required to follow a given set of
procedures.
 Sops are also helping to newly trained employees.
 Serves as a vital tool for any institute or organization to operationalize and
communicate key policies and regulations
SOP TYPES

 Fundamental SOPs. These give instructions how to make SOPs of the other categories.
 Methodic SOPs. These describe a complete testing system or method of investigation.
 SOPs for safety precautions.
 Standard procedures for operating instruments, apparatus and other equipment.
 SOPs for analytical methods.
 SOPs for the reagents preparation.
 SOPs for receiving and registration of samples.
 SOPs for Quality Assurance.
 SOPs for archiving and how to deal with complaints.
 CONTENT OF SOP
 SOP number
 Version number
 Date of issue
 Date of expiry
 Title
 Author
 Status (title submitted; being drafted; draft ready; issued)
 Department of holders/users
 Names of holders
 Number of copies per holder if this is more than one
 Registration number of SOPs to which reference is made
 Historical data (dates of previous issues)
OTHER THINGS FOR MAKING GLP

1. Do not eat, drink, chew gum, use tobacco, apply cosmetics, or

handle contact lenses in the laboratory or in animal rooms.
2. Food and drinks, including water, shall not be stored in the
laboratories.
3. Do not use laboratory equipment for food preparation. Do not use
empty food containers for laboratory materials or samples.
4. Microwave ovens in the laboratory shall only be used for
research purposes.
 ……….THINGS FOR MAKING GLP

5. Smoking is not permitted in laboratories or

animal rooms.
6. Shaving or brushing teeth is not permitted
in laboratories.
7. Keep hands away from the mouth, nose,
eyes, face and hair when working in the
laboratory.
8. Books and journals should be used only in
clean areas if possible.
…. THINGS FOR MAKING GLP

9. Wash hands frequently after handling chemicals and

biological materials, after removing gloves and other personal
protective equipment and before leaving the laboratory.
10. Decontaminate work surfaces and all potentially contaminated
equipment used at the end of the experiment or at the end of
the day with an appropriate disinfectant.
11. In laboratory proper clothing is required
 PROPER CLOTHING IS REQUIRED

 Wear closed toe shoes and long pants or long skirt.

 Remove loose jewelry and jewelry that may compromise or tear gloves or get caught up
in equipment.
 Secure loose hair and clothing to avoid contact with flames, equipment, and potential
contamination.
 Do not wear potentially contaminated protective clothing out of the laboratory area.
 Dispose of contaminated clothing into biohazard bags or hampers designated for
collecting contaminated clothing.
 Wear the appropriate personal protective equipment in the laboratory
 SAFETY DATA SHEETS (SDS)

 A document holding all kinds of hazardous and safe

handling information’s which are prepared in
agreement with the requirements of the federal
Occupational Safety and Health Administration
(OSHA) standard for that document.
 There are 16 sections of a Material Safety Data Sheet.
They include brand-specific information such as
physical data (solid, liquid, color, melting point, flash
point, etc.)
 SAFETY DATA SHEETS (SDS)
Safety data sheets have sixteen sections.
 The early sections, one through eight (1-8) - focus on quick access to essential information that might
be required by chemical handlers for safe handling practices or by emergency response personnel.
 Sections nine through eleven (9-11) - contain technical and scientific data, e.g., stability, reactivity,
physical & chemical properties.
 Sections twelve through fifteen (12-15) - are not mandatory; however, they are required to be fully
GHS compliant.
 The last section, section sixteen, contains information about the SDS itself, e.g., the revision date and
changes since the last version.

GHS (Globally Harmonized System) is a set of international guidelines that were

developed by the United Nations. These guidelines were created to ensure the safe
manufacturing, handling, use, disposal, and transport of hazardous materials
Reference link for SDS: https://www.esdscom.eu/english/euphrac-phrases/sds-templates/
BIOSAFETY PROGRAM MANAGEMENT

 ISO 14001 is an internationally recognized standard that defines environmental

management systems.
 A biological safety program management system, following the process identified by
ISO 14001, is an organized and documented approach to managing biosafety issues
within an organization.
 The aim of such a system is to help employees and other stakeholders effectively and
efficiently accomplish the organization’s goals and objectives relative to the safe,
secure, and legal use of biological materials.
 BENEFITS OF AN EFFECTIVE BIOSAFETY MANAGEMENT
PROGRAM

Effective biosafety management program show great benefits including

 Improved compliance and reduced incidents and liability,
 Efficiency and cost reduction,
 Improved safety performance,
 Increased integration of biosafety issues into the organizational culture
 Improving the behavior of the community and regulatory bodies towards an organization
 promoting the organization as a good “risk” for those who provide funding or purchase
products or services
STEPS OF AN EFFECTIVE MANAGEMENT SYSTEM

1. Setting a policy
2. Planning actions to support the policy
3. Implementation of the plan
4. Monitoring and measuring performance,
5. Establishing corrective and preventive action to address
issues of nonconformance
6. Conducting regular program and management reviews
 1 - POLICY

 A biological safety policy is what the organization wants to achieve and establishes commitments with
regard to biosafety
 It could be defined as, “the Biosafety Program develops and oversees programs to facilitate and promote
the safe, secure, and legal handling, transport, use, and disposal of biological materials in laboratory,
animal, or clinical research.”
Methods for achieving above goal
 Research program review through the biosafety Committee
 Assessments and audits of work practices, facilities, and equipment for use at established biosafety
containment levels
 Consultation and training regarding occupational exposure to potentially hazardous biological materials
 2 - PLANNING

 Developing a program plan provides framework for establishing

goals and objectives, developing strategies for their
achievement, and allocating resources to implement those
strategies.
 Hazard Identification
 Legal Requirements: All legal constraints imposed on an organization to
control its biological materials should be identified. These include federal, state (or
provincial), and local laws and regulations, permits, registrations, orders, and consent
decrees.
 Risk assessment
 Establishing objectives and targets
 3 - IMPLEMENTATION

 In order to put the policy and plan in place, roles, responsibilities, authority, and accountability
must be identified and assigned.
 Practices, processes, and procedures may be established.
 Determining structure to support an effective biosafety program and assigning responsibility
 Training, awareness, and competence
 Communication
 Documentation and Records
 Operational Controls: effective operational controls will identify appropriate engineering controls
(such as biological safety cabinets), work practices, and the use of personal protective equipment.
 Emergency Response plan and procedures
TRAINING

 Personnel including students or employee who work in

laboratories, shall be trained and proficient in
 General lab practices
 Basic microbiological practices
 Basic chemical handling practices

The PI should document lab specific training and Standard

Operating Procedures (SOPs)
 TRAINING…..

Training should identify

1. The importance of conforming to biosafety requirements,
2. Significant biohazards associated with work activities,
3. Means to protect against and prevent exposure to
biohazards,
4. Specific roles and responsibilities
5. Potential consequences of not following procedures.
TRAINING PLAN

 Person(s) responsible for coordinating the training

 Types of training (lectures, one-on-one sessions, on-the-job sessions, simulations, videotape, seminars,
train-the-trainer sessions, etc.)
 Organization that will deliver the training
 Course material to be provided
 Exams and certifications
 Venue
 Dates/schedule
 Identified trainees
 Training evaluation
 Training revision.
4 - MONITORING AND MEASURING

 Implementation of the program is verified by

providing a mechanism to track and evaluate
progress towards achievement of established
objectives and targets.
 There are two components:
 Establish monitoring and measuring procedures
 Track compliance with legal and other requirements.
5 - CORRECTIVE AND PREVENTIVE ACTION

It provides the framework for identifying and correcting problems related to biosafety in
the overall system relative to its goals and objectives,
 Key steps in corrective and preventive action are
 Tracing symptoms of a problem to its root cause
 Producing solutions to prevent the recurrence of the problem
 Implementing changes
 Monitoring that the changes have been successful
6 - PROGRAM AND MANAGEMENT REVIEW

 Effectiveness of the program is reviewed by

monitoring and measuring the component of the
biosafety management program
 Periodic review by upper management is a planned
review designed to ensure that the program
continues to reflect and achieve organizational goals
over the long term
BIOSAFETY COMMITTEE

 A biosafety committee should be constituted to develop

institutional biosafety policies and codes of practice.
 The biosafety committee should also review research protocols
for work involving infectious agents, animal use, recombinant
DNA and genetically modified materials.
 Evaluate the risk assessments and formulation of new safety
policies.
 OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION (OSHA)

 A federal agency of the United States Department

of Labor
 Assure safe and healthy working conditions for
working men and women by setting and enforcing
standards and by providing training, education and
assistance
 Part of federal government governs for workplace
safety
A BASIC BIOSAFETY COMMITTEE INCLUDE…

1. Biosafety officer(s)
2. Scientists
3. Medical personnel
4. Veterinarian(s) (if work with animals is conducted)
5. Representatives of technical staff
6. Representatives of laboratory management.
 BIOSAFETY OFFICER

 A biosafety officer should be appointed to ensure that biosafety policies and programs are
monitored consistently throughout the laboratory.
 The biosafety officer implements these duties on behalf of the head of the institute or
laboratory.
 The designated person should hold the professional competence necessary to suggest,
review and approve specific activities that follow appropriate biocontainment and biosafety
procedures.
 The biosafety officer should apply relevant national and international rules, regulations and
guidelines, as well as assist the laboratory in developing SOPs.
 The person appointed must have a technical background in microbiology, biochemistry and
basic physical and biological sciences.