Multi-source GMP knowledge base for sterile pharmaceutical manufacturing — PDA Technical Reports, ISPE Guidelines, FDA, PIC/S Annex 1, ISO standards. HTML dashboards + AI-queryable Markdown.
-
Updated
Jul 13, 2026 - HTML
#
aseptic-processing
Here are 4 public repositories matching this topic...
GMP-compliant CLI tool to analyze aseptic process simulation (media fill) contamination data per USP <1116> – contamination rates, Wilson score confidence intervals, and Cochran-Armitage trend test.
-
Updated
Jun 21, 2026 - Python
A GMP-compliant CLI tool to assess aseptic media fill runs using exact binomial confidence intervals and regulatory acceptance criteria (PDA, USP).
-
Updated
Jun 25, 2026 - Go
CLI tool to statistically evaluate media fill results (aseptic process simulation) against acceptance criteria using binomial confidence limits, per USP <1116> and GMP expectations.
-
Updated
Aug 5, 2026 - Python
Improve this page
Add a description, image, and links to the aseptic-processing topic page so that developers can more easily learn about it.
Add this topic to your repo
To associate your repository with the aseptic-processing topic, visit your repo's landing page and select "manage topics."