GxPlex

EU GMP Annex 15

EudraLex Volume 4, Annex 15 — Qualification and Validation

in force as of 30 March 2015

Last verified: Last observed: SHA-256: 50a728365a3bb10f991e3266a2efdcbaa57d68add68296126ddeb6dcf6f1c609

Resolution: listing resolved

Authority
European Commission
Jurisdiction
EU
Status
in force
Effective date
Last changed
Last verified
:
Watch cadence
weekly
Crawlable
yes · renders server-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) health.ec.europa.eu
Listed at
discovery route (opens in new tab) health.ec.europa.eu
Topics
qualification · validation · GMP · computerised systems

Current status#

Recorded as in-force against the primary source on 31 July 2026.

No evidence record is stored for the current status.

Observation history#

First observed 31 July 2026. Last observed 3 August 2026. 14 observation(s) recorded.

14 of those returned a document to a standard HTTP client and produced a content hash.

No change to the retrieved text has been detected since observation began.

Sources#

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. EudraLex Volume 4, Annex 15 — Qualification and Validation [instrument record]. Observed 31 July 2026. https://gxplex.com/instrument/eu-gmp-annex-15 Primary source: https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en?filename=2015-10_annex15.pdf

BibTeX

@misc{gxplexinstrumenteugmpannex15,
  author       = {{GxPlex}},
  title        = {{EudraLex Volume 4, Annex 15 — Qualification and Validation}},
  year         = {2026},
  note         = {instrument record, observed 31 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/eu-gmp-annex-15}},
  urldate      = {2026-07-31},
  url          = {https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en?filename=2015-10_annex15.pdf}
}

APA

GxPlex. (2026). EudraLex Volume 4, Annex 15 — Qualification and Validation [instrument record]. Retrieved 31 July 2026, from https://gxplex.com/instrument/eu-gmp-annex-15

Observation history

Observed on 14 occasion(s) since 2026-07-31. 14 produced a content hash.

··············

One mark per observation, oldest first. · unchanged · ! content changed · ~ fetched but rendered client-side, no hash · × could not be fetched, no hash.

First observed
2026-07-31
Last observed
2026-08-03 (HTTP 200)
Fetch method
direct
Current hash
50a728365a3bb10f991e3266a2efdcbaa57d68add68296126ddeb6dcf6f1c609

Subject and class (as stated)

The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.

Dates

Recorded dates for this instrument
DateEvent ConfidenceSource
2015-03-30 effective date
EU GMP Annex 15 recorded as in force as of this date
confirmed link (opens in new tab) · retrieved

Sources

Last updated: