EMA Distant Assessment Guidance

Recommendation

16/17 May 2023

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Supervision of the Pharmaceutical Quality System: Challenges and Opportunities

Currently, on-site GMP/GDP inspections may not be possible because of reasons linked to the Covid-19 pandemic. As a result, Distant Assessments can support and help determining compliance with GMP/GDP principles and guidelines. EMA has now published a GMP/GDP Distant Assessment Guidance document (EMA/335293/2020), providing points for consideration to inspectors relating to Distant Assessments.

What is a "Distant Assessment"?

The documents starts with a useful definition of Distant Assessments: "Assessment of the compliance of a site with the Union GMP/GDP principles performed by officials of Union Competent Authorities on the basis of documents and interviews and supported by technology for communicating, accessing systems, sharing and reviewing documents and other information, without the inspectors being physically present at the sites where the activities subject to the assessment have taken place and where the inspection would ordinarily be hosted". However the authors clearly point out that the "guidance is not intended for use or to replace on-site inspections outside of crisis situations" and that "on-site inspections should be conducted when circumstances permit following the distant assessment". Limited or short on-site inspection in the EEA should be considered "if it is compatible with travel restrictions, health measures, and other restrictions".

Although mainly written for EU-GMP/GDP inspectors, the document gives useful guidance to GMP/GDP-Auditors from Pharmaceutical and API Industry and those who are involved in preparing and managing Distant Assessments (or remote audit, as some might still call it).

What are the pre-requisites?

• A risk assessment should support the decision making
• Early contact should be made to determine feasibility
• The use of appropriate platforms should allow for timely provision of data and electronic documents
• The use of teleconference/videoconference or alternative should allow real time discussions
• Evaluation of the capability for the live sharing of screens displaying computerised systems used at the site
• Provision of appropriate cameras or video recordings to allow remote review of manufacturing operations, equipment, facilities and relevant documentation such as logbooks

What are the key points for preparation and conduct?

The Guidance document gives details on planning, announcement, opening meeting, performance and closing meeting. Most of this is similar to on-site inspections however takes into consideration the certain circumstances.