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GMP

Methodology

How we source, grade, and review regulatory claims

We publish one kind of material: plain-language explanations of published GMP standards, written so that an operator can understand what the text requires and then go and read the text itself. This page sets out the status ladder we apply to every regulatory claim and the three rules that govern everything we publish.

Expert-signed pages

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Zero is correct while no one has signed. Automation may lower a page’s trust level, but it may never raise it.

  1. 01DraftUnverified material that you can read as education, but that isn’t presented as a signed fact or submitted for indexing.
  2. 02CitedA primary source is attached, but no one has yet signed to confirm that the page says what the source says.
  3. 03Expert-signedA named, credentialed reviewer has checked the page against that version of the source and confirmed it.

  1. 1. Every regulatory claim traces to a named primary source

    We cite only the publisher of record: the European Commission for EudraLex Volume 4 (including Annex 7), the EMA for the GACP guideline, the ICH database for ICH Q7, the eCFR for 21 CFR Parts 210 and 211, and the FDA/DEA primary record for US federal questions. We use industry bodies, consultancies, and vendor blogs to help find a source, but never as the source itself. If a regulatory value has no primary citation, we don’t publish it. The page explains the general framing and leaves the figure out.

  2. 2. Every claim carries a status on a three-rung ladder

    Every regulatory value on the site is in one of three states. DRAFT means it is unverified and isn’t presented as fact. SOURCE_LINKED means a primary source is attached. SME_VERIFIED means a credentialed reviewer opened that source and confirmed it says what we claim. Only a person can grant that top status; no automated process can. Sourced is not the same as verified, and only SME_VERIFIED takes the draft label off a page. Automation on this site can lower a page’s trust state, but it can never raise it.

  3. 3. A credentialed QP or RA professional reviews each guide before it is indexed

    Review is a separate step from sourcing. Sourcing establishes that a value exists in a document. Review establishes that a named person with the right credential agrees the page is a fair account of that document. No guide carries an expert signature yet, and no page on the site suggests otherwise. We don’t invent reviewers, dates, or certificates to make a page look finished.

See also our editorial and ethics policy and the regulatory timeline.