Stem cell therapy sterility assurance is becoming more important in the pharmaceutical industry. The genetic manipulations of the cells involved create a powerful tool to treat serious diseases, such as cancer. In 2017, the Food and Drug Administration (FDA) made several advancements towards the regulation of stem cell therapy,,,
Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.
This paper addresses The 3 Steps of Developing a CCS: Assessment, Acceptance, and Remediation.
1. Assessment: Outline the CCS
2. Acceptance: Compilation of CCS Documentation
3. Remediation: CCS Evaluation
This FAQ paper is a follow up to the webinar, Leveraging Microbial Contamination Monitoring Data for Actionable Insights to Meet and Exceed the Auditor’s Expectations. Questions submitted during and after the webinar are answered in this paper.
