Industries
API manufacturing
Active pharmaceutical ingredient manufacturers sit at the raw-material end of the supply chain, where a single unqualified supplier or an expired certificate can hold up every formulator downstream. The workflows below are built around that specific position in the chain.
Start with supplier qualification
Confirming an incoming raw-material lot has a valid, in-spec, currently-qualified CoA on file before it reaches your line is the single most common gap we’ve found across QMS, ERP, and LIMS software for API manufacturers — it’s usually nobody’s discrete job. Our Supplier & CoA Qualification tool exists specifically to own that check.
Relevant tools
- Supplier & CoA Qualification — Verify every incoming batch has an in-spec, non-expired CoA from a qualified supplier before it reaches your line.
- Export Documentation & Compliance — CoAs, CoPPs, WHO-GMP certificates, and shipping documents — tracked, versioned, and never expired without warning.
- Country Dossier Checklist — Living, country-specific dossier checklists for CTD, ACTD, and Module 1 requirements across emerging markets.
- Deviation & CAPA Tracker — Mobile-first deviation logging and CAPA tracking built for the shop floor, not just the QA office.
On ICH Q7 and GMP for APIs
ICH Q7 is the reference guideline most API manufacturers build their quality system against, particularly around raw-material qualification, batch documentation, and supplier oversight. Plumely is built with those workflows in mind — we don’t claim certification against ICH Q7 or any other standard; that determination is your quality system’s to make.