Lecture 1 - GLP Slides.pdf

Good Laboratory Practice (GLP) Ensuring Quality and Integrity in Laboratory Operations A basic guide for biomedical and bioengeering Students By Frank J. Hernandez What is this course about? Provide basic information about Good Labo...

Good Laboratory Practice (GLP) Ensuring Quality and Integrity in Laboratory Operations A basic guide for biomedical and bioengeering Students By Frank J. Hernandez What is this course about? Provide basic information about Good Laboratory Practice (GLP) and demonstrate its implementation in experimental labs during the course. Gain knowledge about the regulatory system governing non- clinical work and understand its importance. Learn the fundamental terminology and concepts necessary to comprehend industry requirements and standards  Different types of labs It was not me!!!!! GLP Research Teaching Products/services Publications & Funding Knowledge & Education GLP in a nutshell Science Academic work Quality Compliance & Integrity Introduction to GLP What is GLP? A set of principles intended to ensure the quality, integrity and compliance of non-clinical laboratory studies. Quality Reagent /materials Assurance certification Speciment/sample Instrumentation tracking validation Accountability Certification of analysts Certification of Statistical Documentation & laboratory facilities procedures records  GxP GLP Good Laboratoy practice Non-Clinical Link between GCP Good Clinical practice Clinical trials GxP GMP Good Manufacturing practice Production GxP Interaction Agencies applying GLP Research and Discovery Good Laboratory Practice (GLP) Good Clinical Practice (GCP) Good Manufacture Practice (GMP) Pharmaco-Vigilance (PV) Good Distribution Practice (GDP) Organisation for Economic Co-operation and Development  Main source for GLP information https://www.oecd-ilibrary.org/environment/oecd-series-on-principles- of-good-laboratory-practice-and-compliance-monitoring_2077785x GLP and the story behind Before the mid-1970s, authorities generally accepted safety study reports on industrial chemicals, potential drugs, and pesticides without question. Scientists were trusted to deliver complete, accurate, and unbiased data. In 1976, significant events in the USA led to a shift in how scientists were trusted, resulting in the development of Good Laboratory Practice (GLP) principles for Non-clinical laboratories studies (21 CFR Part 58). These principles are now applied worldwide and are mandatory for non-clinical product testing. Class discussion about the paper: History of FDA Good Laboratory Practices Why is GLP important? GLP guarantees that data obtained in non-clinical studies are reliable and reproducible, which is essential for evaluating the safety and effectiveness of pharmaceuticals, chemicals, and other products. GLP implementation is often mandatory for studies submitted to regulatory bodies like the FDA, EMA, and OECD member countries. Compliance with GLP streamlines regulatory review and approval processes. GLP offers a globally recognized framework, fostering collaboration and data sharing among laboratories and regulatory bodies worldwide. Key Principle of GLP 1. Organization and Personnel 2. Study planning and Documentation 3. Facilities and Equipment 4. Test system and data collection 5. Quality assurance Key Principle 1: Organization and Personnel Responsibilities: Clearly defining roles and responsibilities promotes accountability. The test facility management, study director, and quality assurance personnel each carry specific duties.  Key Principle 1: Organization and Personnel Test facility management Overall Responsibility: Ensures that the facility is in compliance with GLP regulations. Resources: Provides adequate resources (staff, facilities, equipment) to conduct studies. Personnel Training: Ensures personnel are adequately trained and qualified. Standard Operating Procedures (SOPs): Ensures SOPs are in place and adhered to. Facility Maintenance: Maintains and monitors the facility's infrastructure and environment to ensure it supports GLP-compliant work.  Key Principle 1: Organization and Personnel Study director Single Point of Control: Has overall responsibility for the design, conduct, interpretation, and reporting of the study. Protocol Approval: Ensures the study protocol is developed and approved. Study Conduct: Ensures the study is conducted according to the protocol and GLP regulations. Data Integrity: Ensures the integrity of data collected and maintains the study records. Reporting: Prepares and signs the final report, ensuring it accurately reflects the conduct and results of the study.  Key Principle 1: Organization and Personnel Quality assurance Compliance Monitoring: Independently monitors the conduct of studies to ensure compliance with GLP. Inspections and Audits: Conducts regular inspections of study activities, facilities, and records. Reporting: Reports any deviations from GLP to test facility management and the study director. Documentation: Maintains records of all quality assurance activities. Training and Guidance: Provides training and guidance on GLP compliance to facility personnel.  Key Principle 1: Organization and Personnel What is a Standard Operating Procedure (SOP)? A document that details the necessary steps to consistently and efficiently complete specific tasks within an organization  Key Principle 2: Study planning & Documentation Study planning Create a Study Plan: ✓ Define what the study aims to achieve, ✓ Outline how the study will be conducted, including methods and materials. ✓ Get necessary approvals before starting. Assign Resources: ✓ Ensure qualified staff are assigned to the study. ✓ Make sure the necessary facilities and equipment are available. Follow Standard Procedures: ✓ Use up-to Document any deviations from these procedures and explain why.  Key Principle 2: Study planning & Documentation Documentation Collect and Manage Data: ✓ Keep accurate and complete records of all data and observations. ✓ Ensure data is secure, confidential, and easily traceable. Report and Archive: ✓ Prepare interim reports as needed to show progress. ✓ Write a final report with all findings and conclusions. ✓ Archive all study documents and data securely for future reference. ✓ -date standard operating procedures (SOPs) for all tasks. Key Principle 3: Facilities and Equipment Facility: Design: Built to support study needs and prevent contamination. Maintenance: Keep clean and well-maintained. Space: Provide enough space for all materials and activities. Equipment: Appropriate: Use the right equipment for the job. Calibration: Regularly check and maintain equipment. Records: Keep detailed logs of use and maintenance.  Key Principle 4: Test system and data collection System Requirements: Overview of hardware and software systems used to collect and manage data, ensuring they meet GLP standards. Data Integrity: Processes and protocols to ensure accuracy, consistency, and security of data collected. Documentation: Importance of thorough and precise documentation for traceability and reproducibility. Validation: Procedures for validating systems and data collection methods to confirm they function as intended.  Key Principle 4: Test system and data collection Data integrity ALCOA ALCOA +  Key Principle 5: Quality assurance QA: aims to report high standards of accuracy and reliability Independent Oversight: QA provides unbiased reviews of study processes and data to ensure compliance with GLP regulations. Regular Audits: Routine inspections and audits of procedures, documentation, and facilities to identify and correct deviations. Training and Competency: Ensures all personnel are adequately trained and qualified to perform their tasks. Documentation Review: Systematic checks of study plans, reports, and raw data to verify completeness and correctness. Corrective Actions: Implementing and tracking corrective actions for identified deficiencies to prevent recurrence. Compliance Verification: Continuous monitoring to ensure adherence to GLP guidelines and regulatory requirements. Summary of GLP process Resources: This course was adapted from the course “Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management: from RQA FDA website OECD website Sketchbuble https://www.colabra.ai/blog/what-are-good-laboratory-practices- compliance/ Qual Assur J 2003; 7, 157–161. DOI: 10.1002/qaj.228 https://www.collaboris.com/standard-operating-procedures-a- complete-guide-scope-and-purpose/