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.
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Jul 13, 2026 - HTML
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aseptic-processing
Here are 4 public repositories matching this topic...
CLI tool to statistically evaluate media fill results (aseptic process simulation) against acceptance criteria using binomial confidence limits, per USP <1116> and GMP expectations.
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Aug 5, 2026 - Python
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.
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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).
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Jun 25, 2026 - Go
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