Good Laboratory Practice (GLP) in Pharma-LikeWays

1. Good Laboratory Practices

2. Good Laboratory Practices GXP Definitions

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. 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

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

25. Get ready to use editable documents in MS Word Format Regulatory standard SOPs (Including Format, Template, and Annexure) Starting at Only Rs-49₹/- Contact: Email: contact@likeways.co.in WhatsApp/Telegram No: +919738137533(Only for Message) Note: Kindly note that you will receive the document through email only after the payment has been completed. Please send the screenshot of your payment confirmation via WhatsApp/Telegram. A payment QR code will be provided from our end.