One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies. The way in which study data, supporting human, animal and environmental safety assessment, is generated, handled, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies.
One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies. The way in which study data, supporting human, animal and environmental safety assessment, is generated, handled, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies.
One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies. The way in which study data, supporting human, animal and environmental safety assessment, is generated, handled, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies.
One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies. The way in which study data, supporting human, animal and environmental safety assessment, is generated, handled, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies.
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)
