There are several possible occupational hazards in laboratories. Employees may be exposed to a variety of chemicals, biological agents, hazardous waste, and even radioactive materials because they labor there for extended periods. Numerous of these substances may affect people's health and the environment in the long run. Therefore, it's crucial to adhere to best practices for laboratory management to guarantee worker safety and stop any contamination or leaks outside the lab. Additionally, possible manufacturing techniques are tested in labs to track and regulate the efficacy of the final product. Therefore, product efficacy and quality control for the production process are strongly tied to lab safety.

1. Good Laboratory
Practices

2. GXP Definitions
GLP GMP GCP
Good Laboratory
Practice (GLP) is a
quality system
concerned with the
organizational process
and the conditions under
which nonclinical health
and environmental
safety studies are
planned, performed,
monitored, recorded,
archived and reported.
Good Manufacturing
Practice is the part of
Quality Assurance which
ensures that products
are consistently
produced and controlled
to the quality standards
appropriate to their
intended use and as
required by the
Marketing Authorization
or product specification.
Good Manufacturing
Practice is concerned
with both production and
quality control.
Good Clinical Practice
(GCP) is an
international ethical and
scientific quality
standard for designing,
conducting, recording
and reporting trials that
involve the participation
of human subjects.
Good Laboratory Practices

3. WHY?
• The goal of GLP is to certify that every
step of the analysis is valid.
• Standard Operating Procedures (SOP)
• Quality Assurance Unit (QAU)

4. • The QC laboratory provides service and is
like a manufacturing unit – its “products”
include test results, advice and
investigations
• Needs
– buildings, personnel, resources
– equipment, raw materials
– quality assurance programme
Introduction

5. Guidelines and Regulations
• THE OECD PRINCIPLES OF GOOD LABORATORY
PRACTICE (GLP)
– Non-clinical health and environmental safety studies covered by the principles of good
laboratory practice include work conducted in the laboratory, in greenhouses, and in
the field.
• WHO Guidelines
• WHO Technical Report Series, No. 908, 2003, Annex 4
• WHO Technical Report Series, No. 822, 1992, Annex 1
Organization for Economic Co-operation and Development (OECD) is an
international organization that works to build better policies for better lives.

6. Organization and management
• Personnel
– Managerial and technical positions ensure operation in
accordance with quality systems or procedures for
performing tests and/or calibrations, validation, and
verification, and to initiate actions to prevent or minimize
such departures

7. Organization and management
• Organizational chart and job descriptions
– Describes responsibility, authority and inter-relationships of
all personnel
• Supervision and training
– Adequate supervision of staff is provided, including
trainees, by persons familiar with the test and/or
calibration, validation and verification methods and
procedures, as well as their purpose and the assessment of
the results

8. Organization and management
– Technical manager/HODs, have overall responsibility for the
technical operations, and the provision of resources needed
to ensure the required quality of laboratory operations
• Safety
– Appropriate safety procedures shall be in place
– Safety Officers monitor compliance of safety policies within
the plant

9. Laboratory Quality System
• Establishment, implementation and maintenance of quality
system appropriate to the scope of activities, including the
type, range and volume of testing and/or calibration,
validation and verification activities undertaken
– Policies, systems, programmes, procedures and instructions
are in place
• Documentation used in this quality system must be
communicated, made available, understood and implemented
by the appropriate personnel

10. Laboratory Quality System
• Organogram: Organizational chart wherein operational and
functional activities are defined
• General quality assurance procedures followed throughout the
facility include knowledge and understanding of
– Standard Operating Procedures
– Entry Exit Procedures
– Gowning and Safety Procedures
– Good Documentation Procedures
– Change Controls
– Deviations/Incidents
• Training and maintaining competence of staff

11. Laboratory Quality System
SOPs: Standard Operating Procedures are written, reviewed and
authorized and placed with controlled access
For administrative and technical operations, such as:
• Receipt, Internal labelling, quarantine and storage of materials
in QC e.g. samples, reference material, reagents, raw materials
– Sample Receipt, Management, Storage and Disposal.
– Appropriate installation of each instrument and equipment
• Sampling and inspection
• Testing materials, describing the methods and equipment used
• Qualification, analytical apparatus

12. Laboratory Quality System
• Calibration, maintenance, cleaning, sanitation
• Documentation in the Vernacular (local) language employed in
the laboratory
• Temperature and Environmental monitoring
• Qualification of personnel for Product Testing
• Preparation and Control of biological reference materials
• Specific quality assurance procedures followed in QC Lab
include
– Use of Protocols
– Use of AWS
– Use of Equipment Log Books
– Use of Test Request Forms (TRF)
– Use of Laboratory Notebooks (LNB) - TBD

13. Laboratory Quality System
• Procedure for dealing with complaints often include reporting
Out of Specifications, OOLs, OOTs and Deviations.
• Corrective action and Preventive action - CAPA (for testing
discrepancies) as defined by QA
• Details of internal and external audits
• Safety measures
• Personnel matters including
– qualification, training, clothing, and hygiene

14. Laboratory Test Results and
Records
• All original observations or raw data, calculations and derived
data, calibration, validation and verification records, etc. and
final results are retained on records for an appropriate period
of time in accordance to national regulations ( as per Our
defined SOPs)
– All Data captured on Work Sheets, Reports.
• Records to contain sufficient information to permit repetition
of tests and include, e.g.:
– Identity of the personnel involved in sampling, preparation
and testing of the samples
– Instruments, equipment, etc.

15. Laboratory Test Results and
Records
• Procedures are in place for identification, collection, indexing,
access, storage, maintenance and disposal of quality
documentation and technical records
• All final results are retained on records for an appropriate
period of time in accordance to national regulations
• The records of samples for legal proceedings should be kept
according to legal requirements.

16. Laboratory Data Processing Equipment
• Includes computers, automated tests or calibration equipment
• Used for collection, processing, recording, reporting, storage or
retrieval of test and/or calibration data
• Laboratory Analytical Equipment's which produce raw data
outputs include
– Weighing balances
– Automated Instruments such HPLC/GC
– Stability Software's
– Software's such as Parallel Line Analysis and Probit Analysis
• Procedures in place to describe how:
– Changes are made, documented and controlled for information
– To protect and keep back-up data at all times
– To prevent unauthorized access or amendments to the data

17. Personnel
• Competence ensured for activities, performing tests and/or
calibrations, validations or verifications, evaluation of results
and signing test reports, certificate of analysis, and calibration
certificates
• Staff undergoing training – supervised, with formal assessment
after training
• Personnel must be qualified on the basis of appropriate
education, training, experience and/or demonstrated skills

18. Personnel
• Permanently employed, or under contract
• Contracted personnel to be supervised and sufficiently
competent, motivated – work complying good practice of the
laboratory
• Current job descriptions are in place for managerial, technical
and key support personnel
• Records of competence, educational and professional
qualifications, training, skills and experience
– Readily available, and include date of confirmation of
competence, plus criteria for confirmation and name of the
confirming authority

19. Premises
• Separate areas for receipt, storage, sample preparation and
testing to prevent contamination or mix-ups
• Cold Room, Freezers and Deep freezers for samples to be
maintained at low temperature conditions
• Controlled access to special testing areas such as Sterility
Testing
• Separate areas for secure storage of samples, retained samples,
reagents, laboratory accessories, reference materials
• Safe storage of hazardous substances
• Fire regulations
• Flammable reagents, fuming and concentrated acids, bases,
volatile amines – safe storage separately

20. Laboratory Safety
• Handling and disposal of wastes
– Decontaminate biomedical waste in dedicated autoclaves
– Liquid waste generated shall be drained off to kill tank after
decontamination in dedicated autoclave
– Yellow color bins – animal waste, blood and body fluids,
stocks or specimens of micro organisms, live or attenuated
vaccines, media culture(Biohazard/Biomedical)
– Red Color bins – Glassware and tips
– White Color bins – Sharps
– Needle Burners – incinerate needles

21. Laboratory Do’s
• Wear Personnel Protective Equipment : Lab coats, appropriate
shoes, safety goggles (prescribed glasses) and gloves
• Keep work area neat and free of any unnecessary objects.
• Know emergency procedures
• Turn off all heating apparatus, gas valves, and water faucets
when not in use
• Keep the floor clear of all objects (e.g., ice, small objects,
spilled liquids, boxes)
• Immediately report any spills, accidents, or injuries

22. Laboratory Do’s
• Follow all safety guidelines given in SOPs while testing
• Check the label to verify it is the correct substance before
using it
• Handle hot glassware and apparatus using appropriate gloves.
• Use the laboratory chemical fume hood when there is a
possibility of release of toxic chemical vapors, dust, or gases.
• Always use a spatula or scoopula to remove a solid reagent
from a container.
• Document all procedures and results concurrently
• Follow GDP while making any entries in log books etc

23. Laboratory Don’ts
• Do not sit on work benches
• Never use laboratory glassware for eating or drinking purposes.
• Eating, chewing of gum and drinking in laboratory is forbidden
• Performance or unauthorized experiments is strictly forbidden
• Never leave experiments while in progress
• Never attempt to catch falling objects

24. Laboratory Don’ts
• Never fill a pipette using mouth suction. Always use a pipetting
device.
• Never add water to a concentrated acid.
• Don’t use damaged glassware or equipment. In case of
equipment requiring repair notify supervisor immediately
• Do not directly touch any chemical with your hands.
• Never touch, taste, or smell any reagents or inhale the vapors.
• Follow appropriate containerization methods when handling
biohazard waste

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