{"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":"
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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

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<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n

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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>
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<\/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>
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<\/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

In particular, the document describes in detail the inspection process and relevant regulatory requirements associated to it.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Introduction to the GCP Inspection Process<\/span><\/h2>\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>
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<\/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

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<\/span>Formation of the GCP Inspection Team<\/span><\/h2>\n

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>
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<\/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

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<\/span>Notification and Scheduling<\/span><\/h2>\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>
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<\/span>This notification, generally issued 7-10 days before the inspection, includes details like the study, proposed sites, and inspection dates. <\/span>
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<\/span>In triggered inspections, the notice period may be shorter, and inspections can be unannounced.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Pre-inspection Requirements<\/span><\/h2>\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>
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<\/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

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<\/span>Inspection Preparation<\/span><\/h2>\n

Once the inspection dates are confirmed, the inspection team reviews all relevant documents and finalizes the inspection plan. <\/span>
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<\/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

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<\/span>Inspection Execution<\/span><\/h2>\n

The document further describes the key steps of the inspection process, namely:<\/span><\/p>\n