Considerations and Steps for Building a Contamination Control Strategy (CCS)
Mass-produced pharmaceuticals have come far since the industrial manufacturing of synthetic drugs at the end of the 19th century with rapid advancement in technology, process control, and sterility requirements. Yet even as improvements to Pharma develop and stick, recalls still occur with regularity and their significant impact on both the manufacturer and consumer are why worldwide regulation of the industry is so enforced. Environmental monitoring (EM) is one facet of the greater picture of current good manufacturing practices (cGMPs) that has been standardized for the safety of human health.
Download this paper by Anna Campanella of Particle Measuring Systems (PMS), to get specific insights to:
- The importance of viable and non-viable particle data, and where to find environmental monitoring (EM) limits.
- Where and how to fit Quality by Design into your process.
- Steps to creating and completing your Contamination Control Strategy (CCS).
- How to use Quality Risk Management to ensure regulatory compliance.