Adopted by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee on 15 November 2024, the two new guidelines for inspectors Guidance on Remote Assessments (PI 056-1) and Aide Memoire on Remote Assessments (PI 057-1) entered into force on 1 January 2025. Starting from the same date, it applies also revision 4 of the Guidelines for Accession to the Pharmaceutical Inspection Co-operation Scheme (PS/W 14/2011 (Rev. 4)).
The PIC/S Scheme is open to participation by competent regulatory authorities of different geographical regions that comply to the requirements and procedures established by the Scheme itself, based on the mutual confidence between the associated parties. Guidance PS/W 14/2011 (Rev. 4) provides information on the accession procedure to be followed by regulatory authorities interested in applying for participation in the PIC/S Scheme. We summarise the main features of the new documents.
A consolidated inspection tool
The Aide-Memoire and the Guidance on Remote Assessment (including hybrid inspections) have been drafted by the PIC/S Working Group to provide GMP inspectors with a harmonised approach to conducting GXP assessments from remote across different geographical areas. This type of practice was first introduced during the pandemic as a way to perform inspections of manufacturing plants despite the lockdowns and then consolidated as a possibility to conduct various kinds of regulatory assessments from remote.
The new guidance outlines five different cases where it is possible to run remote assessments and hybrid inspections, i.e. in case travel restrictions would occur or for re-inspections of a manufacturer already characterised by a good level of compliance and limited activities for the inspected site. Remote assessment could also be used to verify certain aspects of corrective or preventive actions, rapidly assess GMP aspects in specific circumstances, or gather information for an inspection. The PIC/S should also support the improvement of inter-agency communication, facilitate reliance on GMP inspection and allow more efficient use of global inspection resources.
Three types of remote assessment
The level of interaction between GMP inspectors and the inspected facility determines the specific type of remote assessment applicable to the case. The table in the appendix to the guideline resumes the differences between kind of remote assessment.
Fully Interactive Remote Assessments rely on the complete procedure to be carried out remotely by national competent authorities (NCAs), using different types of audio, video and document-sharing technologies to interact with the inspected site. Various terms could apply in other regions to identify this type of assessment, i.e. remote inspection, virtual inspection, desktop inspection, or distant assessment. Among the typical features highlighted by the PIC/S guidance are fully interactive video meetings and video streaming of the inspected areas, including document sharing and video discussions or video interviews of subject matter experts located at the firm. The review of QA documents should start during the preparation phase, and it should be, as for manufacturing records and QC documentation, as comprehensive as during on-site inspections. Assessment of corrective and preventive plans could also occur. The process is closed by the issuing of a final report.
Partially Interactive Remote Assessment (also defined as distant assessment, virtual assessment, or remote GMP evaluation) refers to the inclusion of some interactive components in the remote assessment, which does not require a fully interaction to occur. In substance, meetings and interviews with experts and review of QA/QC and manufacturing documentation, are only organised if deemed necessary. All relevant documentation should be shared through agreed IT tools or platforms (e.g. e-mails, screen sharing, etc.). In this case, too, a report is the outcome of the process.
The third procedure is Desktop Assessment (also known as desktop paper assessment, remote GMP evaluation, or document assessment), which is based only on the NCA’s remote review of the relevant documentation without interaction with the inspected site. The process often closes with issuing a compliance note; an on-site inspection could be required in case deficiencies are identified during the desktop assessment.
The combination of on-site and remote assessment results in the so-called hybrid inspections. According to the PIC/S guidance, this could refer to a single inspector performing both the on-site and remote inspection activities or to the presence of different on-site and remotely connected inspectors (possibly representing other regulatory agencies).
How to prepare and run a remote or hybrid inspection
The PIC/S guidance lists the technical requirements to consider when preparing for a remote or hybrid inspection. The Aide-Memoire provides a list of prompts and the respective references to guide the preparation of the needed activities.
The elements to be included depend on the desired level of remote interaction, and may interest among others the availability of conferencing software, secure shared data storage, and robust data connection. High efficiency scanning should also be available to scan relevant documentation. The verification of data integrity could be based on sharing of the screens of computerised systems.
Preparatory activities to be run before the remote assessment should include a teleconference to inform the company of relevant details for the inspection, as well as technical and logistical requirements. A connectivity test should also be performed, and all relevant documentation shared through secure tools. Should translations be needed, machine translation can be used, provided it is indicated.
Inspectors should run the fully or partially remote assessments according to the same principles used for on-site inspections, taking in due consideration elements such as different time zones. The extension of the documentation to be assessed by a desktop procedure has to be precisely defined ahead of the actual assessment.
The PIC/S guidance also indicates that the suitability of a remote assessment or hybrid inspection should be determined based on a risk assessment. Should high and/or multiple medium risk factors emerge from this exercise, and if they cannot be considered acceptable even after mitigation, an alternative approach to run the inspection should be considered. The guidance provides some examples of factors to be considered in the risk analysis, including the previous inspection history of the site, the type of activities performed, or the time passed since the last on-site inspection. Information on the site coming from other regulators or sources (including complaints, intelligence or whistleblowers) should also be considered. Other valuable elements to inform the decision include changes that occurred at the site since the last inspection, the number of buildings involved, the organisational culture and site communication style.
The final report of the remote assessment should clearly mention the specific type of inspection performed, the inspected areas, and those not involved in the assessment. In case a GMP certificate is issued, this also should clearly state the remote, on-site or hybrid assessment. To support the issuing of GMP certificates, the Appendix to the PIC/S guidance also provides some examples of standard phrases to be used.
