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来源：GMP干货
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently released two documents aimed at creating a harmonized approach for planning, conducting, and following up on remote and hybrid inspections among its members.
The documents also highlight important factors for assessing whether certain high-risk facilities are unsuitable for remote evaluations.
One document provides guidance on conducting remote assessments, while the other is an aide memoire to complement the inspection guideline.
The documents were developed by the PIC/S Working Group on Remote Assessments, which is led by Jenny Hantzinikolas from Australia’s Therapeutic Goods Administration (TGA). The group approved both documents on November 15; they will go into effect on 1 January 2025.
In the inspection guidance, PIC/S states that remote assessments and hybrid inspections will continue to be important tools in an inspector's toolkit even after the COVID-19 pandemic.
The guidance for remote assessments describes important principles for planning, conducting, and following up on remote inspections. Its aim is to establish uniformity among inspectorates in carrying out these inspections. This consistency will enhance communication between agencies, promote reliance on Good Manufacturing Practice (GMP) inspections, and lead to more efficient use of global inspection resources.
The guidance outlines the differences between fully interactive remote assessments, partially interactive remote assessments, desktop assessments, and hybrid inspections.
It discusses the logistics for conducting remote assessments, including the necessary technical aspects such as adequate conferencing software and reliable data connections.
For desktop inspections, the guidance outlines the documents that should be reviewed, such as previous inspection reports and core standard operating procedures requested from the firm.
The guidance also outlines several factors for specific high-risk facilities where a remote assessment may not be the preferred option. These factors include sites with a history of previous inspections, facilities that engage in aseptic operations, or those that have not been inspected in over four years. Additionally, sites with recalls, complaints, or those under a whistleblower complaint are included. All these factors are considered high-risk and could lead to the necessity of an onsite inspection.
The aide memoire document provides best practices and summaries for preparing for and conducting remote assessments and post-inspection activities. It includes prompts and questions to guide users through these processes.
When planning remote inspections, the aide memoire suggests that inspectors consider holding a teleconference with the site prior to the inspection to discuss the assessments. It also recommends using various breakout rooms to allow for simultaneous discussions among different inspectors at the site.
The guide recommends that inspectors conduct connectivity tests prior to remote assessments. This includes evaluating the type of network, expected bandwidth, and the hardware to be used. Additionally, inspectors should consider utilizing independent translators.
To conduct remote assessments, inspectors must consider how to present their identification at the site. Additionally, they should prepare a daily schedule to ensure that subject matter experts (SMEs) are available for interviews.
The guide also addresses post-assessment activities and recommends that inspectors consider the type of documentation they will use after the remote assessment, such as a remote assessment report or a list of observations. Additionally, it suggests that inspectors evaluate whether to issue a GMP certificate or an equivalent document following an inspection.
For inspections with “unacceptable compliance outcomes,” inspectors must decide whether to conduct an onsite inspection or withhold a GMP certificate.
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