Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 Frequently Asked Questions
Knowledge Category: Regulatory
How to Build a Contamination Control Strategy: 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.
Contamination Control Strategy (CCS) Build – Questions and Answers
Answers to questions asked during the webinar “Considerations and Steps for Building a Contamination Control Strategy”. Many questions were asked about contamination monitoring requirements in cleanrooms and sampling placement pertaining to process design.
Cleanroom Design Questions & Answers
This FAQ paper is a follow up to the webinar, “3rd Annual Cleanroom Design and Engineering Forum” presented by Anna Campanella. Many thoughtful questions were asked about non-viable particle counting requirements in cleanrooms and sampling placement pertaining to process design. Questions submitted during and after the webinar are answered by Anna Campanella, below. If you have any additional queries for our experts, submit them directly here.
