The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released its "Guidance on Remote Assessments" effective from January 2025, to standardize the use of remote and hybrid inspections as tools for ensuring compliance with Good Manufacturing Practices (GMP). These methodologies, developed during the pandemic, have since proven their value and are now formalized for use in diverse scenarios.
Remote assessment including hybrid inspection are inspection processes developed during the pandemic to enable GMP inspections to continue where it has been difficult to conduct these on-site. The guidance aims to:
Standardize remote assessment practices globally.
Facilitate effective GMP inspection reliance across regulatory agencies.
Improve inter-agency communication.
Enhance the efficient allocation of global inspection resources.
The guidance introduces three primary types of remote assessments:
Fully Interactive Remote Assessment: Live, interactive evaluations using video streaming, document sharing, and real-time communication with firm personnel.
Partially Interactive Remote Assessment: Some live interactions with firm personnel combined with document-based evaluations.
Desktop Assessment: A document-only review conducted remotely, with no live interaction with the firm.
Additionally, a hybrid inspection combines remote and on-site assessments.
The logistics for remote assessments include:
Using tools like video conferencing software, secure data-sharing platforms, and live-streaming equipment.
Pre-assessment preparations such as connectivity tests, document uploads, and teleconferences.
Detailed risk assessments to determine the appropriateness of remote methods based on factors like site compliance history, nature of activities, and site complexity.
All inspection reports must indicate the type of assessment conducted (remote, on-site, or hybrid).
Regulatory databases and GMP certificates should reflect the inspection mode.
The effectiveness of remote assessments may be validated during subsequent on-site inspections.
This PIC/S guidance marks a significant step toward modernizing global GMP inspection practices. By leveraging remote and hybrid methods, regulatory authorities can enhance oversight efficiency while maintaining robust compliance standards. For detailed insights, refer to the official guidance.
Also, check this guidance for accession, released by (PIC/S).
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