{"id":32731,"date":"2023-10-19T03:12:24","date_gmt":"2023-10-19T03:12:24","guid":{"rendered":"https:\/\/www.process.st\/templates\/fda-glp-audit-checklist\/"},"modified":"2024-03-05T14:41:06","modified_gmt":"2024-03-05T14:41:06","slug":"fda-glp-audit-checklist","status":"publish","type":"post","link":"https:\/\/www.process.st\/templates\/fda-glp-audit-checklist\/","title":{"rendered":"FDA GLP Audit Checklist"},"content":{"rendered":"\n<section id=\"identify-and-gather-appropriate-documents-and-data-for-review\"> \n <h2>Identify and gather appropriate documents and data for review<\/h2>\n <div class=\"text-content\">\n   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. \n <\/div> \n <div class=\"file-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Upload relevant documents and data <\/label> \n   <div class=\"file-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"initial-review-of-the-quality-assurance-program-plan-qapp\"> \n <h2>Initial review of the Quality Assurance Program Plan (QAPP)<\/h2>\n <div class=\"text-content\">\n   Before 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. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Notes on areas for improvement <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"multi-choice-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select any areas for improvement <\/label> <select disabled class=\"form-control\"> <option value=\"\">Multiple options can be selected from this list<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Training programs \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Documentation procedures \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Audit frequency \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Equipment calibration \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Data management \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"evaluate-compliance-with-regulatory-and-organizational-policies\"> \n <h2>Evaluate compliance with regulatory and Organizational Policies<\/h2>\n <div class=\"text-content\">\n   This 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. \n <\/div> \n <div class=\"select-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select the level of compliance <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Full compliance \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Partial compliance \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Non-compliance \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Provide details on any identified gaps or inconsistencies <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"review-facility-attributes-such-as-location-size-equipment-etc\"> \n <h2>Review facility attributes such as location, size, equipment etc<\/h2>\n <div class=\"text-content\">\n   This 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. \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Location of the facility <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Size of the facility <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Notes on equipment and resources <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"review-the-preclinical-study-protocols\"> \n <h2>Review the preclinical study protocols<\/h2>\n <div class=\"text-content\">\n   In 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. \n <\/div> \n <div class=\"multi-choice-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select any areas requiring improvement <\/label> <select disabled class=\"form-control\"> <option value=\"\">Multiple options can be selected from this list<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Study design \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Protocol documentation \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Data analysis methods \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Adherence to timeline \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Sample size determination \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"inspect-study-data-raw-data-documentation-and-test-article-control\"> \n <h2>Inspect study data, raw data, documentation, and test article control<\/h2>\n <div class=\"text-content\">\n   Inspecting 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. \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Check the following <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Study data completeness \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Raw data documentation \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Test article control measures \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Data accuracy \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Data traceability \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"verify-the-handling-of-test-and-control-articles\"> \n <h2>Verify the handling of test and control articles<\/h2>\n <div class=\"text-content\">\n   During 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. \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Review storage conditions <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n <div class=\"multi-choice-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select any deviations identified <\/label> <select disabled class=\"form-control\"> <option value=\"\">Multiple options can be selected from this list<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Improper labeling \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Inadequate segregation \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Cross-contamination \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Misidentification \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"confirm-adequate-training-for-personnel-involved-in-the-studies\"> \n <h2>Confirm adequate training for personnel involved in the studies<\/h2>\n <div class=\"text-content\">\n   This 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. \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Check the following <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Training records and qualifications \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      GLP regulations knowledge \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Study methodologies \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Data handling techniques \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Documentation practices \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"review-the-final-reports-of-the-completed-studies\"> \n <h2>Review the final reports of the completed studies<\/h2>\n <div class=\"text-content\">\n   This 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. \n <\/div> \n <div class=\"select-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select the level of report quality <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      High quality \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Moderate quality \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Low quality \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Notes on deficiencies or areas for improvement in report generation <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"ensure-the-standard-operating-procedures-sops-are-followed\"> \n <h2>Ensure the Standard Operating Procedures (SOPs) are followed<\/h2>\n <div class=\"text-content\">\n   In 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. \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Check the following <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      SOP documentation \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Adherence to SOPs \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Recorded deviations \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      SOP updates or modifications required \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"conduct-interviews-with-staff-and-management\"> \n <h2>Conduct interviews with staff and management<\/h2>\n <div class=\"text-content\">\n   Conducting 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. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Notes on staff and management interviews <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Check the following <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Roles and responsibilities \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Knowledge of GLP requirements \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Implementation of GLP regulations \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Identification of potential gaps \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Recommended actions \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"identifying-any-instances-of-noncompliance\"> \n <h2>Identifying any instances of non-compliance<\/h2>\n <div class=\"text-content\">\n   During 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. \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Check the following <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Instances of non-compliance \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Root causes \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Impact on study integrity \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Recommended corrective actions \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Responsibility for corrective actions \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"approval-qa-manager-to-review-initial-findings-and-issues\"> \n <h2>Approval: QA Manager to review initial findings and issues<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Inspect study data, raw data, documentation, and test article control<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"prepare-preliminary-audit-findings-report\"> \n <h2>Prepare preliminary audit findings report<\/h2>\n <div class=\"text-content\">\n   This 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. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Key findings and areas of strength <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Instances of non-compliance and root causes <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Recommended corrective actions <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"hold-meeting-with-management-to-discuss-findings\"> \n <h2>Hold meeting with management to discuss findings<\/h2>\n <div class=\"text-content\">\n   In 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. \n <\/div> \n <div class=\"members-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select members to participate in the meeting <\/label> <select disabled class=\"form-control\"> <option value=\"A member or group will be selected here\">A member or group will be selected here<\/option> <\/select> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"followup-actions-to-correct-any-noncompliance-found\"> \n <h2>Follow-up actions to correct any non-compliance found<\/h2>\n <div class=\"text-content\">\n   This 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. \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Check the following <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Communication of corrective actions \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Assignment of responsibilities \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Documentation of actions \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Progress monitoring \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Support provided \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"prepare-the-final-audit-report\"> \n <h2>Prepare the final audit report<\/h2>\n <div class=\"text-content\">\n   This task involves preparing the final audit report based on the comprehensive assessment and all the collected information. Summarize the key findings, instances of non-compliance, and the implemented corrective actions. Provide a detailed analysis of the organizational strengths, improvements, and recommendations for sustained compliance. The final audit report serves as a conclusive document highlighting the audit outcomes and the organization's commitment to GLP compliance. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Key findings and areas of improvement <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Instances of non-compliance and corrective actions <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Recommendations for sustained compliance <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"approval-senior-management-to-review-final-audit-report\"> \n <h2>Approval: Senior Management to review final audit report<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Prepare preliminary audit findings report<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"release-the-final-audit-report\"> \n <h2>Release the final audit report<\/h2>\n <div class=\"text-content\">\n   In this task, release the final audit report to the appropriate stakeholders, including the management, quality assurance team, and relevant personnel involved in the preclinical studies. Ensure that the report is comprehensive, well-structured, and clearly communicates the audit outcomes and recommendations. Consider any confidential or sensitive information that may require appropriate handling or redaction before releasing the report. \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Check the following <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Review final audit report \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Ensure confidentiality measures \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Identify report recipients \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Coordinate release \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"schedule-next-audit-date\"> \n <h2>Schedule next audit date<\/h2>\n <div class=\"text-content\">\n   This task involves scheduling the next audit date for the FDA GLP audit. Consider the frequency and requirements of the regulatory audits and the organization's internal audit program. Coordinate with the relevant stakeholders to identify a suitable timeframe for the next audit. Ensure that all necessary preparations and improvements are made before the scheduled audit date. \n <\/div> \n <div class=\"date-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select the next audit date <\/label> \n   <div class=\"date-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-calendar btn-icon\"><\/i> Date will be set here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n <div class=\"members-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select members to coordinate the audit preparations <\/label> <select disabled class=\"form-control\"> <option value=\"A member or group will be selected here\">A member or group will be selected here<\/option> <\/select> \n  <\/div> \n <\/div> \n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>Identify and gather appropriate documents and data for review 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 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ep_exclude_from_search":false,"cover_icon_emoji":"\ud83d\udd0d","cover_icon_url":"","tasks_count":"20","template_description":"","template_id":"mBEgte3u1BHUdStL3HhIcw","task_0":"Identify and gather appropriate documents and data for review","task_slug_0":"identify-and-gather-appropriate-documents-and-data-for-review","task_1":"Initial review of the Quality Assurance Program Plan (QAPP)","task_slug_1":"initial-review-of-the-quality-assurance-program-plan-qapp","task_2":"Evaluate compliance with regulatory and Organizational Policies","task_slug_2":"evaluate-compliance-with-regulatory-and-organizational-policies","task_3":"Review facility attributes such as location, size, equipment etc","task_slug_3":"review-facility-attributes-such-as-location-size-equipment-etc","task_4":"Review the preclinical study protocols","task_slug_4":"review-the-preclinical-study-protocols","task_5":"Inspect study data, raw data, documentation, and test article control","task_slug_5":"inspect-study-data-raw-data-documentation-and-test-article-control","task_6":"Verify the handling of test and control articles","task_slug_6":"verify-the-handling-of-test-and-control-articles","task_7":"Confirm adequate training for personnel involved in the studies","task_slug_7":"confirm-adequate-training-for-personnel-involved-in-the-studies","task_8":"Review the final reports of the completed studies","task_slug_8":"review-the-final-reports-of-the-completed-studies","task_9":"Ensure the Standard Operating Procedures (SOPs) are followed","task_slug_9":"ensure-the-standard-operating-procedures-sops-are-followed","task_10":"Conduct interviews with staff and 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