info@pmeasuring.com

Knowledge Category: Regulatory

Microbial Data Collection environmental monitoring biocapt single use 10 years
Microbial Data Collection: Managing the Expectations of Auditors

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.
contamination control strategy for a fill line
Contamination Control Strategy (CCS) Considerations and Steps

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, 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.