Eesti Farmaatsia GruppESTONIAN PHARMACEUTICAL GROUP
← Insights Practice · Veiko Saluste · 15 November 2026

An SOP changed. Which forms did you miss?

A procedure is revised, approved and trained. Three months later an inspector opens a form that still carries the old limit. Here is why that happens, and a short check to run before the new version takes effect.

In shortEU GMP expects a change to reach every document it affects. Many misses are broken references; in our test set that was seven of fifteen. Fixed rules found six of them, and the local AI found the seventh, a circular reference. The rest are numbers, roles and deadlines copied from one document into another, and finding those takes reading.
1

Why it happens

An SOP is rarely alone. It names forms, appendices, specifications and other SOPs, and other documents quote it in return. When it changes, change control asks which documents are affected, and the answer usually comes from the author's memory.

Your document management system shows which version is in force and who approved it, and many systems track linked documents. What most of them do not compare is content: that the limit in a form was copied from section 5.3 of a procedure that has just been rewritten.

2

What the rules say

  • In force: documents containing instructions are approved, signed and dated, with a defined effective date, and are regularly reviewed and kept up to date (EU GMP 4.3, 4.5). Planned changes are evaluated before they are made and checked afterwards (EU GMP 1.4 (xii)–(xiii), Annex 15 section 11, ICH Q10 3.2.3).
  • Draft: revised texts of Chapter 4 and Annex 11 were published for consultation in July 2025, together with the new Annex 22. No final text had been published when we checked on 15 November 2026.
  • Our view: "which documents are affected" deserves a search, not a recollection, and the search belongs in the change record.
3

Five places a change hides

  • Forms and templates that repeat a limit, a frequency or a role from the SOP.
  • Other SOPs that quote the changed step, or point to a section number that has moved.
  • Specifications and the quality manual that state the same value in their own words.
  • Training records and job descriptions that still name the old version.
  • References out of the SOP: appendices, forms and equipment it names that were renumbered, withdrawn or retired.
4

What we saw in our own test

We planted fifteen errors of exactly this kind in a synthetic quality system of 25 documents. Seven were simple reference errors: a form that does not exist, a superseded version, a wrong title, a missing appendix. Fixed rules found six of them in under a second; the seventh, two SOPs pointing to each other, was found by the AI.

The others needed reading: a deviation closed in 30 calendar days in one SOP and 20 working days in another, assay limits of 90–110 % against a specification of 95–105 %, a procedure still using an autoclave that had been retired. A local AI model found most of these and missed one, a limit given in a table. In total 13 of the 15 were found in full, one in part, and one was missed. Full results and answer key →

5

A short check before the effective date

  • List every document code the SOP mentions and confirm that each exists in its current version.
  • Search the whole document set for the SOP's own code and open every hit.
  • Search for each value you changed: the limit, the frequency, the deadline, the job title.
  • Compare the revision date of each form with the revision date of the SOP it belongs to.
  • Write the searches and their results into the change record.
6

Where AI helps, and where it stops

A model can read the whole document set every time and point to passages that may no longer agree, quoting both. It cannot decide which document is right. That decision, and the change that follows, stay with the document owner and QA. How we check → · What we build with you →