The first domestic off-site inspection guidelines are planned to be released in the post-epidemic era, "delegation of control and service" will deepen

Text|Drip Sinan

The current situation of China's epidemic prevention and control continues to improve, but the rapid spread of the global epidemic has significantly increased the risks and challenges facing China's development

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On June 10, 2020, the European Union EMA took the lead in publishing "Guidance on remote GCP inspections during the COVID-19 pandemic" internationally; on October 15, 2020, the European Union EMA Also released "Guidance relate to GMP/GDP and PMF distant assessments" (GMP/GDP and PMF remote assessment guide), which introduces the detailed process of planning, preparation and implementation of remote assessment; the new implementation will be implemented on December 1, 2019.

✦(1) Avoid the personal and health risks of on-site supervision and inspection personnel caused by force majeure such as sudden infectious diseases and natural disasters;

✦(2) Based on the drug GSP compliance risk of drug business sites, reduce the economic burden of compliant drug business sites for inspections, and reduce the investment of supervision and inspection agencies;

✦(3) Further improve the supervision and inspection ability and level of drug dealers inspectors

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✦(1) The on-site inspection cannot be carried out due to crisis factors such as health risks;

✦(2) The inspected business enterprise or site has a good history of drug GSP and drug GPP compliance, but there are the following situations that require inspection: drug sales, storage, transportation, or multiple business sites (such as chain stores) , Multi-warehouse coordination, etc.

✦(3) When necessary, a mixed inspection method can be adopted

✦It needs to be specially explained: due to inspections, initial permit inspections and other circumstances that are not applicable to off-site inspections, on-site inspections should be adopted

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(1) Two preparations

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(2) Three steps for off-site inspection

The first stage: inspection start-off-site inspection preparation and data verification

✦Time limit requirements: The inspection team is generally completed within 1 working day; the inspected company should generally reply within 2 working days and provide relevant electronic documents
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✦Implementation points: In accordance with the off-site inspection plan, an inspection team is formed, an off-site inspection plan is developed, and an off-site inspection notice is formally issued to the inspected company, informing the preparation requirements and materials to be submitted
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The materials that need to be submitted include at least the following:

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The master file of the drug business site or the quality and safety information report of vaccine circulation activities;

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List of documents of the drug business quality management system;

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If drugs are entrusted for sales, storage, and transportation, provide relevant quality audit reports, quality agreements and regular on-site audit reports
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The second stage: remote assessment and inspection report writing

✦Time limit requirements: The inspection team generally conducts remote evaluation within 1 working day
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✦Implementation points: According to the first-stage data review and remote evaluation, the inspection report should be completed in accordance with the requirements of the "Pharmaceutical Business Activity Inspection Report Format and Writing Guidelines", and the off-site inspection conclusions should be proposed
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The third stage: Comprehensive assessment and disposal of inspection results

✦Time limit: generally completed within 3 working days after off-site inspection

✦Implementation points: if the inspection result basically meets the requirements or does not meet the requirements, it shall be handled in accordance with the "Administrative Measures for Administrative Measures for Pharmaceutical Business Activities"
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If suspected of violations of laws and regulations, a case should be filed for investigation and handling
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references

[1] fda.
hubei.
gov.
cn