A post-approval manufacturing change has two lives. In Quality, it is a change control record: proposed, assessed, approved, implemented, verified, closed. In Regulatory, it is a set of filings: a prior-approval supplement in one market, a notification in another, an annual report entry in a third.

In most companies those two lives are tracked in different systems. They meet in email, in a spreadsheet and in the memory of whoever coordinates them. And that is where a familiar inspection finding comes from: a change control closed as complete while a required approval was still pending in one market.

Put the markets on the change

The fix is not more coordination. It is a single record. In DnXT Quality Processes, each change control lists its affected items — sites, products, materials, equipment, documents, systems and markets. Each affected market carries two things:

  • A reporting category: none, annual report, notification or prior approval.
  • A status: not required, planned, submitted, approved or rejected — with the reference it rests on, linked to the registration and the submission.

A major or minor change cannot be submitted without at least one affected item, and a market must state its reporting category. A filing that is required cannot be marked as not required.

Let the filing state decide closure

Then the rule that matters: closure waits on the regulatory status.

  • A prior-approval market must be approved.
  • A notification market must be submitted or approved.
  • An annual-report market must be at least planned.
  • Any rejected filing blocks closure.

Because each market is linked to the registration and the submission, the status reflects the regulatory record rather than a value someone typed into a quality form. The change cannot close before the filings it depends on are where they need to be.

The rest of a change control that holds up

Markets are the part most quality systems miss, but they sit inside a process that has to be robust in its own right:

  • Impact assessments are assigned per function to a named assessor with a due date, and completed with a signature.
  • The approval route for each change class is company configuration, changed only by a Quality Manager with a signature. A change under approval keeps the route it was submitted with.
  • Independence is enforced. The originator cannot approve the change; the implementer cannot approve its closure. Each role is filled by a named person from a maintained role register.
  • A rejection starts a new cycle. Approvals given before it no longer count and must be given again; the earlier signatures stay in the history.
  • Emergency changes can start on a recorded verbal approval, and must be approved retrospectively within a set window.
  • Effectiveness checks, where required, are a step before closure, not an afterthought.

Every signature records the signer’s printed name, the date and time, and its meaning, and any record can be produced as a PDF with its full signature manifest.

Why it belongs in one system

The gap between Quality and Regulatory is not a people problem. Both teams usually know exactly what they are doing. It is a records problem: two systems, each correct on its own, with nothing that stops one from closing while the other is still waiting.

When the change and its regulatory consequences live in the same record, the question “can we close this?” has an answer the system can enforce. Quality Processes is currently in early access for companies managing manufacturing changes across several markets.

DnXT builds eCTD publishing, submission planning, document management and dossier review software for regulatory operations teams. Book a demo to see a manufacturing change tracked from impact assessment to market approvals in one record.