Manufacturing, CMC & supply
Deviation triage, batch record review, process modelling, forecasting and inspection — the GMP estate, where the validation bar is highest and the payback is fastest.
- Deviation & CAPA triage
- Batch record review
- CMC & process development
- Supply planning & forecasting
- Visual inspection & PAT
The guide
The long, definitive pieces on manufacturing. Everything else on this page goes deeper on one part of them.
5 articles
Specific problems, specific answers, each written against a named source and dated.
Review by Exception After Twenty Years of Trying
Pfizer struggled two decades with electronic batch records; costs per site fell eighty percent once leadership changed, not the software.
Manufacturing · 13 min readFDA's First AI Warning Letter Cites a 1978 Rule
Purolea used AI agents to draft specifications and batch records; FDA cited the quality unit rule, not any AI legislation.
Manufacturing · 11 min readSerialisation Proves Where a Package Went, Not Whether the Next One Ships
Two hundred twenty-seven active shortages, half sole-source, and manufacturers reporting most causes unknown: what supply chain AI can genuinely predict.
Manufacturing · 11 min readDigital Twins Cannot Release Your Batch
FDA says a control strategy relying solely on process models is insufficient, and that sentence caps every real-time release pitch.
Manufacturing · 13 min readWhy Adding Agents Makes Deviation Investigations Worse
Agentic deviation triage cuts investigation time sharply, yet published evidence shows pipeline and swarm architectures degrade regulated decision quality badly.
Manufacturing · 11 min read