Video Quality 19 min
Six Sigma Explained: DMAIC, CTQs and Variation in the Age of AI
Six Sigma fundamentals, recast for operations where part of the work is done by AI agents.
Article Regulatory 6 min read
FDA’s Warning Letter on AI-Written GMP Documents: What It Requires
What FDA cited when AI agents wrote a manufacturer’s drug procedures and specifications, what it asked for instead, and how to review an AI-drafted document so a missing requirement shows.
Article Regulatory 6 min read
EU GMP Annex 22: Can Generative AI Be Used in GMP Work?
What the EU’s draft GMP annex on artificial intelligence says about generative AI, what industry and regulators said at EMA’s 2026 expert workshop, and what a reviewer of AI output needs to know.
Article Quality 6 min read
Can a Supplier’s CoA Replace Your Own Testing? What FDA Requires
The two conditions FDA’s drug manufacturing rule puts on accepting a supplier’s certificate of analysis, what its warning letters found when firms skipped them, and how the supplement rule compares.
Article Regulatory 6 min read
How Long Is a Leaping Bunny Supplier Declaration Valid?
Why one supplier’s cruelty-free declaration can be current under the US and Canada Leaping Bunny Standard and out of date under Cruelty Free International’s twelve-month rule, and how to tell which rule a brand’s file is read against.
Article Regulatory 5 min read
EU Fragrance Allergen Labeling Starts With the Supplier Declaration
What the EU's expanded fragrance allergen labeling requires and by when, and why the hard part is keeping the supplier's declaration current.
Article Quality 6 min read
“None Detected” on a CoA: What It Means Without a Detection Limit
Three phrases on test reports and certificates of analysis that look like answers and are not, and what to ask a supplier for instead.