08.17.23 -- 4 Key Considerations for Onshoring or Nearshoring Drug Production

The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.

Is reshoring or nearshoring right for your organization? It's important to undertake rigorous internal assessments to arrive at a decision. Here are four key considerations.

The publication of the ASTM (American Society for Testing and Materials) E3106 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation in 2018 brought an increased emphasis on performing cleaning process development studies prior to any validation efforts.