Inspecting GMP at a Distance

"The term 'virtual inspection' applies to inspections that are performed off-site through the use of enhanced communication and information technology to fulfil legal requirements of on-site inspections," IFMPA said in an updated document on virtual inspections in July (2). The E...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2020-12, Vol.32 (12), p.6-8
Main Author: Milmo, Sean
Format: Article
Language:English
Subjects:
COVID-19
Good Manufacturing Practice
Manufacturing
Regulatory agencies
Online Access:Get full text
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Summary:"The term 'virtual inspection' applies to inspections that are performed off-site through the use of enhanced communication and information technology to fulfil legal requirements of on-site inspections," IFMPA said in an updated document on virtual inspections in July (2). The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA), representing national authorities, together with the European Commission have introduced a system during the pandemic under which the validity of GMP certificates for European manufacturing and importing sites for finished products and active substances will be extended to the end of 2021 (3). "The advantage of an assessment/inspection/ certification by a local inspectorate includes knowledge of the site-specific history, insight into culture, optimization of (regulatory agency) resources, and benefits from improved inspection logistics (e.g., no language barriers, less travel)," the EFPIA paper explained.
ISSN:1753-7967