This task involves identifying and gathering all the necessary documents and data that will be reviewed during the FDA GLP audit. The goal is to ensure that all relevant information is available for the audit process. This may include reports, study protocols, records, and any other documentation related to the preclinical studies. The task also involves organizing the collected documents and data in a structured manner for easy access and reference during the audit.
Upload relevant documents and data File will be uploaded hereBefore starting the audit, it is important to conduct an initial review of the Quality Assurance Program Plan (QAPP). The QAPP outlines the policies, procedures, and standards that ensure compliance with FDA GLP regulations. During this task, review the QAPP to gain an understanding of the organization's quality control measures, audit procedures, and overall compliance system. Pay special attention to any areas that require improvement or adjustment.
Notes on areas for improvement Select any areas for improvement Training programs Documentation procedures Audit frequency Equipment calibration Data managementThis task focuses on evaluating the organization's compliance with regulatory and organizational policies related to FDA GLP. Review the policies and procedures in place to ensure that they align with regulatory requirements. Look for any gaps or inconsistencies that may need to be addressed. Assess the effectiveness of the policies in promoting compliance and maintaining the integrity of the preclinical studies.
Select the level of compliance Full compliance Partial compliance Non-compliance Provide details on any identified gaps or inconsistenciesThis task involves reviewing the attributes of the facility where the preclinical studies are conducted. Assess the location, size, layout, and overall suitability of the facility for conducting GLP-compliant studies. Evaluate the equipment and resources available, ensuring that they meet the necessary requirements. Take note of any deficiencies or areas that require improvement to ensure the integrity and reliability of the study results.
Location of the facility Size of the facility Notes on equipment and resourcesIn this task, review the preclinical study protocols that have been conducted at the facility. Evaluate the design, methodology, and execution of the studies to ensure compliance with FDA GLP regulations. Check if the protocols are well-documented and clearly outline the objectives, procedures, and data analysis methods. Identify any areas of improvement or potential non-compliance with the regulations.
Select any areas requiring improvement Study design Protocol documentation Data analysis methods Adherence to timeline Sample size determinationInspecting study data, raw data, documentation, and test article control is a crucial part of the FDA GLP audit. Review the collected data and documentation related to the preclinical studies. Ensure that the data is complete, accurate, and well-documented. Verify the control measures in place for test article handling to prevent contamination or mix-ups. Look for any issues or discrepancies that may affect the validity and reliability of the study results.
Check the following Study data completeness Raw data documentation Test article control measures Data accuracy Data traceabilityDuring this task, verify the handling of test and control articles throughout the preclinical studies. Assess the storage conditions, proper labeling, and segregation of test and control articles. Check if the articles are handled in accordance with FDA GLP regulations to prevent cross-contamination or misidentification. Identify any deviations from the required procedures and recommend corrective actions if necessary.
Review storage conditions Select any deviations identified Improper labeling Inadequate segregation Cross-contamination MisidentificationThis task focuses on confirming the adequacy of training provided to the personnel involved in the preclinical studies. Review the training records and qualifications of the individuals conducting the studies. Assess if they have received appropriate training on GLP regulations, study methodologies, and data handling. Identify any gaps in training and recommend additional training if necessary.
Check the following Training records and qualifications GLP regulations knowledge Study methodologies Data handling techniques Documentation practicesThis task involves reviewing the final reports of the completed preclinical studies. Assess the structure, content, and overall quality of the reports. Verify if the reports contain all the necessary information required by FDA GLP regulations. Check if the reports accurately summarize the study findings and provide appropriate conclusions. Identify any deficiencies or areas for improvement in the report generation process.
Select the level of report quality High quality Moderate quality Low quality Notes on deficiencies or areas for improvement in report generationIn this task, ensure that the Standard Operating Procedures (SOPs) related to the preclinical studies are followed consistently. Review the SOPs to verify if they are up-to-date, well-documented, and aligned with FDA GLP regulations. Check if the personnel involved in the studies adhere to the prescribed procedures and record any deviations from the SOPs. Identify any gaps in the SOPs and recommend updates or modifications if necessary.
Check the following SOP documentation Adherence to SOPs Recorded deviations SOP updates or modifications requiredConducting interviews with staff and management provides additional insights and perspectives on the preclinical studies and the organization's compliance with FDA GLP regulations. During the interviews, ask relevant questions to understand their roles, responsibilities, and knowledge of the GLP requirements. Identify any potential gaps in understanding or implementation of the regulations and recommend necessary actions to address them.
Notes on staff and management interviews Check the following Roles and responsibilities Knowledge of GLP requirements Implementation of GLP regulations Identification of potential gaps Recommended actionsDuring this task, identify any instances of non-compliance with FDA GLP regulations or organizational policies. Review all the collected information, observations, and findings from the audit process. Identify any inconsistencies, deviations, or violations that may compromise the integrity and reliability of the preclinical studies. Document the instances of non-compliance and provide recommendations for corrective actions.
Check the following Instances of non-compliance Root causes Impact on study integrity Recommended corrective actions Responsibility for corrective actionsThis task involves preparing a preliminary audit findings report based on the observations and identified instances of non-compliance. Summarize the key findings, including any areas of strength and areas requiring improvement. Provide a detailed analysis of the instances of non-compliance, their root causes, and recommendations for corrective actions. The preliminary audit findings report serves as a basis for further discussions with the management.
Key findings and areas of strength Instances of non-compliance and root causes Recommended corrective actionsIn this task, hold a meeting with the management to discuss the preliminary audit findings and recommendations. Present the key findings, instances of non-compliance, and their impact on the preclinical studies. Engage in a constructive discussion to clarify any issues, address concerns, and provide further insights. Seek management's commitment to take appropriate actions to rectify the identified non-compliance and improve the organization's GLP compliance.
Select members to participate in the meetingThis task involves following up on the actions necessary to address the instances of non-compliance identified during the audit. Collaborate with the responsible individuals or teams to implement the recommended corrective actions. Ensure that the actions are effectively communicated, assigned to the relevant personnel, and documented for tracking and review. Monitor the progress of the corrective actions and provide support as needed.