Regulatory authorities worldwide carry out pharmacovigilance (PV) inspections to ensure that marketing authorization holders (MAHs) and their partners comply with all applicable PV regulations, obligations, and standards. These inspections assess both products and operational processes. National competent authorities appoint inspectors to perform these evaluations, which may be either announced or unannounced. In the case of announced inspections, authorities notify MAHs and related organizations of the inspection schedule in advance.
The primary objectives of PV audit inspections are to confirm that MAHs’ systems, infrastructure, and processes meet regulatory requirements, and to detect any instances of non-compliance that could potentially endanger patient safety. When non-compliance is identified, corrective measures must be taken to mitigate risks.
Types of Pharmacovigilance Inspections:
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System-based pharmacovigilance inspections
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Product-specific pharmacovigilance inspections
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Routine inspections
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For-cause inspections
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Pre-authorization inspections
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Announced and unannounced inspections
For More Details Read our blog -: https://resource.ddregpharma.com/blogs/preparedness-for-inspections/
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