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Good laboratory practices awervness course ay
The document discusses good laboratory practice (GLP) standards, including the history and purpose of GLP, key aspects of GLP such as facilities, equipment, personnel, documentation, and quality assurance, and the consequences for noncompliance with GLP, which include potential disqualification from conducting laboratory studies and starting new studies. GLP standards were established to ensure the integrity and reliability of nonclinical safety data submitted to regulatory authorities and promote consistent practices internationally.
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Overview of GLP and its significance, agenda items include GLP essentials and historical development.
Key components of GLP, including fundamentals, resources, rules, documentation, and quality assurance.
GLP's origins from FDA, global impact, and reasons for establishment due to poor lab practices and investigations.
Ensures accurate data reflection, traceability, and reduces false positives/negatives in lab testing.
Core missions of GLP including quality assurance, organization, management, and basic operating procedures.
Requirements for lab cleanliness, appropriate design, and maintenance of premises for safety and compliance.
Importance of qualified personnel, their roles, maintenance of SOPs, and oversight of audit processes.
Proper management and documentation of reagents and lab equipment, including calibration and storage.
Detailed guidelines on representing bulk samples, written SOPs, labeling, and cleaning of sampling equipment.Importance of documentation in GLP, detailing record keeping processes for data integrity and compliance.
Guidelines for laboratory testing, validation of methods, quality assurance programs, and compliance checks.Documented quality policy, audit responsibilities, and corrective actions based on non-conformities.
SOP requirements for various lab processes, including analysis, safety, and documentation control.
Consequences faced by facilities not adhering to GLP, including potential disqualification and FDA procedures.
Recap of essential GLP components: facilities, trained personnel, validated methods, and record integrity.
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Good laboratory practices awervness course ay
- 1. Good Laboratory Practice Edited & Preparedby ADEL YOUNIS Quality & BD Consultant PHD in TQM Awareness Course
- 2. Agenda GLP BOK. History of Standard Development GLP Essentials -resources -characterization -Rules -results -QA Summary
- 3. Good Laboratory Practice- BOK 1) Fundamentals of GLP 2) Resources 2.1 Personnel 2.2 Facility “building & Equipment” 3) Rules 3.1 Protocols / Study plan 3.2 Procedures / SOPs 4) Characterization 4.1 test item 4.2 test system
- 4. GLP – BOK(II) 5) Documentation /Results 5.1 raw data & data collection 5.2 final reports 5.3 archives 5.4 indexing 6) Quality Assurance
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- 6. GLP isa formal regulation that was created by the FDA (United states food and drug administration) in 1978. Although GLP originated in the United States , it had a world wide impact. Non-US companies that wanted to do business with the United states or register their pharmacies in the United States had to comply with the United States GLP regulations. They eventually started making GLP regulations in their home countries. In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard.
- 7. Purpose for creatingGLP standard In the early 70‟s FDA became aware of cases of poor laboratory practice all over the United States. FDA decided to do an in-depth investigation on 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study 3. Inadequate test systems
- 8. One ofthe labs that went under such an investigation made headline news. The name of the Lab was Industrial Bio Test. This was a big lab that ran tests for big companies such as Procter and Gamble. It was discovered that mice that they had used to test cosmetics such as lotion and deodorants had developed cancer and died. Industrial Bio Test lab threw the dead mice and covered results deeming the products good for human consumption. Those involved in production, distribution and sales for the lab eventually served jail time.
- 9. FDA investigation findings •Poorly-trained Study Directors and study personnel • Poorly-designed protocols • Protocols not followed - procedures not conducted as prescribed • Raw data badly collected - not correctly identified - without traceability - not verified or approved by responsible persons • Lack of standardized procedures • Poor animal husbandry
- 10. • Inadequate characterizationof test items and test systems. • Inadequate resources. • Equipment not properly calibrated or otherwise qualified. • Reports not sufficiently verified, inaccurate account of study or raw data • Inadequate archives and retrieval processes FDA investigation findings (II)
- 11. Objectives of GLP GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study. GLP also makes sure that data is traceable. Promotes international acceptance of tests.
- 12. Aim of GLP tomake the incidence of False Negative More obvious to make the incidence of False Positive More obvious
- 13. MISSION OF GLP Test systems Archiving of records and materials. Apparatus, material and reagent facilities. Quality assurance programs. Performance of the study. Reporting of study results. Standard operating procedures (SOP) Personnel and test facility organization
- 14. GLP , WHOapproach Part (1) Management & Infrastructure 1. Organization & Management 2. QMS 3. Control of docs. 4. Records 5. Data processing equipments 6. Personnel 7. Premises 8. Equipments, instruments and other devices 9. contracts Part (3) working procedure 14. Incoming samples 15. Analytical worksheet 16. Validation of analytical procedures 17. Testing 18. Evaluation of test results 19. Certificate of analysis 20. Retained samples Part (2) materials & Equipments 10. Reagents 11. Reference substance & RM 12.Calibration and verification of performance 13. Traceability Part (4) safety 21. General rules
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- 16. Cleanliness Control laboratories& equipment should be kept clean., in accordance with written cleaning schedules. All laboratory personnel should wear clean protective clothing appropriate to the duties being performed. The disposal of waste material should be done carefully & responsibly in accordance with procedures which should be documented. Keep the work place clean & uncluttered& do not get distracted at work by other people.
- 17. Premises Located, designed,constructed or adapted 7 maintained to suit the performance of all quality control tests & analysis required before, during & after manufacture. Away from external & internal traffic.
- 18. Premises (II) Design& construction should prevent entry of rodents & insects Interior surfaces of walls, floors& ceilings should be smooth& free from cracks Temp. & relative humidity should be appropriate for desired functions Bio-burden will be routinely maintained.
- 19. Premises (III) Separatefacility for Instrumentation Chemical analysis/wet chemistry Micro lab/sterility/ pyrogen testing lab Hot room: fuming hood Stability room Reference sample/control samples room
- 20. Premises – animalfacility To minimize the effects of environmental variables on the animal, the facility should be designed and operated to prevent the animal coming into contact with disease, or with a test item other than the one under investigation. Requirements will be different depending upon the nature and duration of the studies being performed in the facilities.
- 21. A typical animalhouse would have separation maintained by provision of areas for : – species – studies – quarantine – changing rooms – receipt of materials – storage - bedding and diet - test doses - cages – cleaning equipment – necropsy – laboratory procedures – utilities – waste disposal. Premises – animal facility – (II)
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- 24. Personnel Adequate education,training & experience keeping of OC, CVs, JDs, and training records is essential Head of laboratory shall be responsible for 1. Maintenance of SOPs, Protocol & documentation 2. Organizing audits & follow up of Corrective action 3. Investigation of technical complaints
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- 26. Reagents The reagentsshould be dated upon receipt or preparation & labeled for identification. Reagents made up in the laboratory should be prepared by competent persons according to laid-down procedures. The labels on the reagent bottles should indicate the concentration, standardization factor, shelf life & storage conditions , date of preparation, date of re-standardisation & signature of the chemist who has prepared it. Reference standards & working standards should be dated & stored at proper conditions. They should be handled & used carefully in consultation with senior chemist. MSDS of hazardous & poisonous chemicals Distilled /DM water- analysis
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- 28. Equipments Laboratory instruments& equipments should be serviced & calibrated at suitable intervals according to written procedures by persons or a service agency & validated. (SOP for operation & calibration) Readily available records must be maintained for each one of them. Next servicing or calibration due date should also be mentioned on them. Separate room under control temp. & humidity
- 29. Equipments (II) Writtenoperating instructions should be readily available or preferably be displayed for each instrument. Records shall have Name of eqip., Mfg.‟s name & instruction manual, model no., list of spares &accessories, etc. Defective instrument should be withdrawn from use until the fault has been rectified.
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- 31. Sampling Sample shouldbe a proper representative of bulk product. A trained & authorized sampler should sample out using appropriate , clean Sampling equipments , following safety precautions & sampling norms.
- 32. Sampling (II) WrittenSampling SOP should include Method of sampling Equipment to be used The amount of sample to be taken Instructions for any required sub division of sample The type & condition of sample container to be used Any special precaution to be observed Cleaning & storage of sampling equipment.
- 33. Sampling (III) TheSample container should have labels bearing details about Name of material, Batch no., Mfg. Date, expiry date , Name of manufacturer,& quantity sampled. Those containers from which samples are drawn, are marked with „sampled‟ stamp with date & signature of the chemist so that they are identifiable from bulk containers. Sampling equipments should be cleaned after each use & stored separately from other laboratory equipments.
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- 35. Documents All thedepartmental systems & procedures , specifications for all input materials, intermediates & finished products & all tests and methods of analysis should be documented. All raw data, formats of analytical reports , under test, approved & rejected labels , various in-process checks , calibration check records should be documented & available. Archives for storage,& retrieval of records. Retention time should be maintained.
- 36. Procedure & documentation Method of analysis & specifications SOP for systems, instruments Reports- Analytical reports of batch, stability report, working standards, validation reports, Monitoring quality of water, effluents discharged, RM, In- process, FP.
- 37. Standard Operating Procedures(II) To store data in paper format, humidity conditions shall be maintained. Data in the form of disc & tape should be stored with care. For storage on optical disc, its life shall be longer than storage time. Keep a photocopy of data on thermal paper.
- 38. Documents Documents shallspecify the title, nature & purpose. They shall be laid out in an orderly fashion & easy to check. Documents shall be approved, signed, regularly reviewed, and dated by appropriate & authorized person.
- 39. Records Raw data refersto records of original observations. Make detailed records of the results of the tests & analyses of all materials, intermediates & finished products & in process tests done, environmental monitoring, calibrations etc. Changes or corrections in the entry should be single line strike. Authorized persons will have access to data to maintain its integrity & security.
- 40. Records Records shouldhave following details. Analytical report no. Name of the sample Date of receipt of sample Batch/lot no. Protocols of tests applied Signature of the analyst Opinion & sign of approved analyst Any other relevant & extra information e.g. date of expiry , date of release & in case of drugs, requirements complying schedule U Records should also contain the basic data & calculations from which test results were derived.(e.g. weighings, readings, recorder charts, instrument printouts etc.)
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- 42. Testing Samples shouldbe tested in accordance with the written methods & referred to in relevant specifications. In- process checks done by QC personnel on the batches in production should also be attached to the analytical reports for the batch. Test methods should be validated. Where the results of testing appear doubtful, repeat the test/s but do not fabricate the results to cover up mistakes or to avoid work.
- 43. Good house keeping& Safety People working in the laboratory should look after safety aspects of their work for themselves, their colleagues &the organization. They should wear appropriate safety gadgets while working with hazardous , corrosive chemicals & inflammable solvents. Persons in the department should be trained to operate fire fighting apparatus. Persons in the department should be familiar to first-aid techniques in case of emergency till medical help is available.
- 44. Good house keeping& Safety (II) Government of specifies SOPs as Circulation of safety data sheet Eating, drinking, smoking and keeping food items in the lab is prohibited. Adequate facilities for storage & disposal of animal waste Protective clothing to be provided.
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- 46. Safety Waste materialsawaiting disposal should be safely stored. Flammable & halogenated solvents & other contaminated waste liquids should not be poured into the drains carrying the factory effluent. They should be collected separately & disposed off suitably . There should be separate waste containers for broken glass.
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- 48. Training Persons inthe department should be adequately qualified & provided suitable training to carry out their responsibilities in a competent & reliable manner. Records of training should be maintained.
- 49. Reference materials Traceableto Government body Or international agency. Working std. shall be prepared using ref. std. & records of same will be maintained Maintain a register for ref. material including source of supply, code no. ID no., storage conditions, mfg. & expiry date. Handled & stored properly.
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- 51. Quality System Documentedquality policy Compliance with GLP Non conformities noted by internal & external audits should be corrected & CA documented. The head of laboratory is responsible for schedule & conduct of the audit.
- 52. Internal system qualityaudits The head of laboratory is responsible for schedule & conduct of audit. Manager will be responsible to maintain all records & protocols of the analysis which are being checked by audit team. Should be carried out by competent personnel to meet regulatory requirements. Any non compliance reported in the audit should be analyzed & CA should be documented.
- 53. Management Review Atleast once in 12 months to cover Internal & external audit report Complaints & customer feedback received from laboratory customers Training records of the staff. Other laboratory requirements.
- 54. Standard Operating Procedures Sopsrequired for Analysis of drugs Sample handling & accountability Receipt, identification, storage & sampling of test & control articles. Cleaning, maintenance and calibration of equipments Responsibilities of audit team personnel.
- 55. Standard Operating Procedures Healthy& safety precaution Storage & maintenance of microbial cultures. Maintenance of animal rooms. Use & storage of reference standards Training programs & their frequency House Keeping Document control
- 56. Standard Operating Procedures Retention& disposal of control samples SOPs should be reviewed periodically SOPs should include designation of the person responsible for intended activity. Complaints & Product recall procedures
- 57. What happens ifa workplace does not comply with federal Good Laboratory Practice standards?
- 58. Disqualification of aFacility Before a workplace can experience the consequences of noncompliance, an explanation of disqualification is needed The FDA states the purpose of disqualification as the exclusion of a testing facility from completing laboratory studies or starting any new studies due to not following the standards of compliance set by the Good Laboratory Practice manual
- 59. Possible Violations Falsifyinginformation for permit, registration or any required records Falsifying information related to testing~ protocols, ingredients, observations, data equipment, ect. Failure to prepare, retain, or submit written records required by law
- 60. Grounds for Disqualification The testing facility failed to comply with one or more regulations implemented by the GLP manual The failure to comply led to adverse outcomes in the data; in other words, it affected the validity of the study Warnings or rejection of previous studies have not been adequate to improve the facility‟s compliance
- 61. Consequences of Noncompliance The FDA states the following consequences of noncompliance: The commissioner will send a written proposal of disqualification to the testing facility A regulatory hearing on the disqualification will be scheduled If the commissioner finds that after the hearing, the facility has complied, then a written statement with an explanation of termination of disqualification will be sent to the facility Thus, if it can be shown that such disqualifications did not affect the integrity and outcome of the study itself, or did not occur at all, then the study may be reinstated at the will of the commissioner
- 62. Upon Disqualification… If thecommissioner finds that the facility was noncompliant on any of the grounds after the hearing, then a final order of noncompliance will be sent to the facility with explanations If a testing facility has been disqualified, any studies done before of after the disqualification will need to be determined as essential to a decision (acceptable or not) If the study is determined unacceptable, then the facility itself may need to show that the study was not affected by the noncompliance that led to the disqualification Once finally disqualified, the facility may not receive or be considered for a research or marketing permit and the study is rejected.
- 63. Summary Adequate facility,trained personnel, approved procedures. Validated test methods Records- Reports, specifications, calibration SOPs Analysis of RM, In-process & FP for release Product complaints & recall