The published changes to the chapter are to continue preventing harm through microbial contamination, excessive bacterial endotoxins and inappropriate quality of ingredients. Additionally, USP 797 was updated to reduce risk associated with unintended physical and chemical contaminants, as well as variability in intended strength. Currently, USP 797 is enforceable by the U.S. Food and Drug Administration, as well as 28 State Boards of Pharmacy.
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