How to Build a Transfer Master Plan Between Sites

Recognizing early warning signs during site-to-site transfers is crucial to mitigating risks. Symptoms may manifest through unexpected deviations in manufacturing processes, quality control data anomalies, or stakeholder concerns. Common signals…

Site-to-Site Transfer Gap Assessment for MSAT and QA

During routine batch testing and quality assessments, the quality control (QC) team observed deviations in the expected assay results of the biologic therapy. Specifically, the potency of three consecutive production…

Site-to-Site Transfer Gap Assessment for MSAT and QA

During the initial weeks of the site transfer, several critical signals emerged that indicated potential risks to product quality and regulatory compliance. Key symptoms included:Click to read the full article.

Site Transfer Case Study: Sterility Assurance Gap

Recognizing the early signs of sterility assurance gaps is crucial. This can help in timely intervention and containment of potential contamination incidents. Symptoms may include:Click to read the full article.

How to Review Receiving Site QMS Before Transfer

During a recent site-to-site transfer project, quality control personnel identified several alarming symptoms that indicated potential issues with the receiving site's QMS:Click to read the full article.