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.
Want to learn how to become compliant with cGMPs? In this paper, by Anna Campanella, of Particle Measuring Systems (PMS), we discuss:
- The importance of viable and non-viable particle data, and where to find EM limits.
- Where to fit Quality by Design into your process.
- Steps to completing a Contamination Control Strategy (CCS).
- How to use Quality Risk Management to ensure regulatory compliance.
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