{"id":605872,"date":"2024-06-03T09:32:54","date_gmt":"2024-06-03T13:32:54","guid":{"rendered":"https:\/\/platohealth.ai\/drap-guidelines-on-good-clinical-practice-inspections-process-pakistan\/"},"modified":"2024-06-04T21:14:03","modified_gmt":"2024-06-05T01:14:03","slug":"drap-guidelines-on-good-clinical-practice-inspections-process-pakistan","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/drap-guidelines-on-good-clinical-practice-inspections-process-pakistan\/","title":{"rendered":"DRAP Guidelines on Good Clinical Practice Inspections: Process | Pakistan","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
The new article describes in detail the relevant inspection process, highlighting the key points to be considered by the parties involved.<\/span><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p>\n \t\t\t\t <\/p><\/div>\n <\/p>\n <\/p>\n The <\/span>Drug Regulatory Authority of Pakistan<\/b><\/a> (DRAP), the country\u2019s regulating agency in healthcare products, has published a guidance document dedicated to conducting and reporting good clinical practice inspections. <\/span> In particular, the document describes in detail the inspection process and relevant regulatory requirements associated to it.<\/span><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\n The <\/span>Good Clinical Practice <\/b>(GCP) inspection is a crucial mechanism designed to ensure compliance with the established standards for conducting clinical trials. It involves a detailed scrutiny carried out by nominated inspectors from the Clinical Standards Committee (CSC) or designated authority. <\/span> <\/p>\n \t\t\t\t According to the guidance, the GCP inspection team is formed by members nominated by the CSC or notified by the Authority. The team\u2019s composition is tailored to the specific requirements of the clinical trial or research being inspected, considering the phase, type of trial, investigational product, and other pertinent variables. <\/span> <\/p>\n As set forth by the relevant requirements, before an inspection, relevant entities such as investigators, sponsors, Contract Research Organizations (CROs), and bio-analytical laboratories are notified of the inspection schedule. <\/span> <\/p>\n By the existing legal framework, inspectees must submit detailed information related to the clinical trial, including enrollment status, standard operating procedures, trial-specific documents such as the Trial Master File, updated CVs of principal investigators, and arrangements for direct access to trial data stored on computerized systems. <\/span> <\/p>\n Once the inspection dates are confirmed, the inspection team reviews all relevant documents and finalizes the inspection plan. <\/span> <\/p>\n The document further describes the key steps of the inspection process, namely:<\/span><\/p>\n <\/p>\n The inspection concludes with a closing meeting where the inspectors present their findings and discuss any issues or non-compliance observed. This meeting is essential for ensuring the inspectee fully understands the inspection outcomes and the necessary corrective actions.<\/span><\/p>\n<\/div><\/div>\n <\/p>\n The scope of the guidelines published by DRAP also covers the matters related to the most essential documents to be used in the context of GCP inspections. In particular, the <\/span>Trial Master File <\/b>(TMF) and <\/span>Investigator Site File<\/b> (ISF) form the core of the documentation reviewed during the inspection. <\/span> <\/p>\n Another critical component of the GCP inspection is the verification of source data, which includes a wide array of medical records, laboratory reports, and case report forms. The availability and accuracy of this data are vitally crucial for validating the trial\u2019s findings and ensuring the reliability of the data collected.<\/span><\/p>\n<\/div><\/div>\n <\/p>\n The document explains that the GCP inspection process is a rigorous and structured approach to ensuring the integrity, compliance, and ethical conduct of clinical trials. From the nomination of the inspection team to the final discussion of findings, each step is designed to scrutinize the trial\u2019s adherence to established guidelines and standards. The comprehensive review of documents, interviews with the trial team, and visits to trial sites are vitally important steps in assessing the trial\u2019s conduct and the quality of the data produced.<\/span><\/p>\n<\/div><\/div>\n <\/p>\n https:\/\/www.dra.gov.pk\/wp-content\/uploads\/2024\/03\/DRAP-Guideline-for-conduct-and-reporting-of-GCP-Inspection-2nd-edition.pdf<\/a><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\n RegDesk<\/strong><\/a> is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.<\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p><\/div>\n \t\t<\/div>\n \n\t<\/div>\n <\/p><\/div>\n <\/p>\n –><\/p>\n The new article describes in detail the relevant inspection process, highlighting the key points to be considered by the parties involved. Table of content The Drug Regulatory Authority of Pakistan (DRAP), the country\u2019s regulating agency in healthcare products, has published a guidance document dedicated to conducting and reporting good clinical practice inspections. The document provides […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":605876,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/605872"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=605872"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/605872\/revisions"}],"predecessor-version":[{"id":605875,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/605872\/revisions\/605875"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/605876"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=605872"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=605872"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=605872"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/span>\n\t\t\t<\/div>\n<\/p><\/div>\n
<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n
<\/span>
<\/span>The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance to them. <\/span>
<\/span>
<\/span>The authority also reserves the right to change the guidelines and recommendations provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. <\/span><\/p>\n<\/span>Introduction to the GCP Inspection Process<\/span><\/h2>\n
<\/span>
<\/span>This process encompasses several stages, from the inspection team\u2019s nomination to the concluding meeting where inspection findings are discussed.<\/span><\/p>\n<\/div><\/div>\n<\/span>\n\t\t\t<\/div>\n
<\/span>Formation of the GCP Inspection Team<\/span><\/h2>\n
<\/span>
<\/span>Inspectors are selected based on their qualifications and GCP certification, ensuring a thorough and competent examination of the clinical trial processes.<\/span><\/p>\n<\/div><\/div>\n<\/span>Notification and Scheduling<\/span><\/h2>\n
<\/span>
<\/span>This notification, generally issued 7-10 days before the inspection, includes details like the study, proposed sites, and inspection dates. <\/span>
<\/span>
<\/span>In triggered inspections, the notice period may be shorter, and inspections can be unannounced.<\/span><\/p>\n<\/div><\/div>\n<\/span>Pre-inspection Requirements<\/span><\/h2>\n
<\/span>
<\/span>This documentation is vitally important for the inspectors to assess the compliance and integrity of the clinical trial.<\/span><\/p>\n<\/div><\/div>\n<\/span>Inspection Preparation<\/span><\/h2>\n
<\/span>
<\/span>This includes familiarizing themselves with the study protocol, informed consent forms, clinical trial reports, and other essential documentation. <\/span>
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<\/span>The objective is to ensure a comprehensive understanding of the trial\u2019s conduct and the data quality generated.<\/span><\/p>\n<\/div><\/div>\n<\/span>Inspection Execution<\/span><\/h2>\n
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<\/span><\/li>\n
<\/span><\/li>\n<\/span>Conclusion of Inspection<\/span><\/h2>\n
<\/span>Essential Documentation and Compliance<\/span><\/h2>\n
<\/span>
<\/span>These files contain all the essential documents required to evaluate the trial\u2019s conduct and data quality. The authority additionally emphasizes the importance of ensuring these files are comprehensive, up-to-date, and accessible for inspection, showcasing the trial\u2019s adherence to GCP standards and regulatory requirements.<\/span><\/p>\n<\/div><\/div>\n<\/span>Source Data Verification<\/span><\/h2>\n
<\/span>Conclusion<\/b><\/span><\/h2>\n
<\/span>Source<\/span><\/h2>\n
<\/span>How Can RegDesk Help?<\/span><\/h2>\n
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