Points to Consider in Remote and Hybrid GMP/GDP Inspections (single user digital version)

May 2021
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Remote assessments increasingly are seen as useful tools in obtaining meaningful insights into a site's operations. But what factors should companies and health authorities consider when adjusting to a remote inspection format? How do you determine, address, and plan for the technological hurdles and considerations in remote inspections?

PDA Points to Consider in Remote and Hybrid GMP/GDP Inspections examines advantages and best practices for planning and implementing all types of remote regulatory inspections, including desktop, virtual, and hybrid inspections. It describes best practices that will help all participants engage efficiently and avoid unnecessary or unexpected delays, stressors, or complications in the remote inspection process. The suggestions in this document may be useful to sites that are the target of inspections and to health authorities.

This Points to Consider document also presents the complete results of a PDA global survey on biopharmaceutical manufacturing experiences related to remote inspections. These results may provide insights about industry's needs and concerns.

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Table of Contents

Table of Contents:

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  1. Planning and Notification of a Remote Inspection
  2. Remote Inspection Realization
  3. Remote Inspection Closing, Conclusion, and Response
  4. References
  5. Relevant Global Guidances
  6. Appendix 1: List of Quality Documents to be Reviewed During Inspection
  7. Appendix 2: 2021 PDA Research: Global Industry Responses to Remote Regulatory Inspections

Figures and Tables Index