Rx-360 Remote Audit Best Practice Guide

Rx-360 through our Member Consortium has developed a Version 1.0 Best Practice Guide for Remote Auditing. This initial version will present a foundation on best practices that the Rx-360 membership have utilized and observed as well as processes that have been incorporated into the Rx-360 Audit Program.

This guide is will be followed by versions that will focus on best practices for specific area such as:

• API
• Supply Chain Security
• Single Use Systems
• Excipients
• GMP / GMP Service Providers
• GDP
• Cell and Gene Therapy

This foundational guide will focus on definition of terms, types of remote auditing, IT capability, pre-audit surveying and a decision tree around deciding on a remote audit versus an onsite audit.

Remote auditing during the coronavirus pandemic of 2019 and 2020 has grown in its utility within the pharmaceutical industry. The processes involved with a remote audit will continue to evolve as the industry continues to adopt best practices. Being able to understand the growing bandwidth issues on both the pharmaceutical supplier side and the manufacturer side will position remote auditing to continue its growth and utilization for the long term.

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