HMA & EMA Revises Joint Audit Programme for GMP Inspectorat

On 2 August 2021, the HMA and EMA released the third revision of the Joint Audit Programme for EEA GMP inspectorates (JAP procedure). The most notable change is the adoption of the Distant Assessment for remote inspections in periods of crisis.

Key changes compared to version 2 are as follows:

4.2: Scope addition to include the Distant Assessment as a result of the COVID-19 pandemic: During crisis, where an on-site regular audit may not be possible, distant assessment of the GMP inspectorate could be carried out. The assessment will be done remotely via suitable means of exchange of information and interviews. The audit team will not perform an observed inspection; it will be postponed to the next regular audit at the latest

4.5: Notifying the auditee

In the case of a distant assessment, the following must also be considered in unison with previous guidelines:

• The use of appropriate platforms for the timely provision of documentation

• The use of teleconference/video conference or alternative system to allow for real-time interviews and discussions between the auditee and the auditors

• The possibility for live sharing of screens displaying computerized systems, information or documentation

• The time zones in which the auditee and the auditors are located

6.2: Collecting information

• Addition to guidance in the case of distant assessment: the way the information is obtained should be adapted to the specific situation, considering the absence of live physical interaction.

Please consult the attached source document for further information.

Reference document: please click here