Good Laboratory Practices

Good Laboratory Practices

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

Introduction
• 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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices

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.
Good Laboratory Practices

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.
Good Laboratory Practices
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
Good Laboratory Practices

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
Good Laboratory Practices

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
Good Laboratory Practices
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
Good Laboratory Practices
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
Good Laboratory Practices
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
Good Laboratory Practices
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
Good Laboratory Practices
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

Good Laboratory Practices
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
If you would like to donate us?
Scan below and donate us 0.013$ (US dollar) (5Rs Indian rupee)
Contact: If you want PPT/PDF files, please contact below.
Email: gnccmysore@gmail.com
Telegram:+919738137533(only for Chat)