GxPlex

DI revision concept paper

EMA and PIC/S concept paper on the revision of GMP guidance on data management and integrity

not yet verified

Last verified: not yet verified Last observed: SHA-256: 208b17ec5cbe3dec1e28bfe934cbc4ff156555c20195553caf8f086f888783f0

Frozen. Only a listing exists; no page describing this document on its own has been found.

Frozen does not mean abandoned. This entry is still fetched and hashed every day and its observation series continues; it is excluded only from the verification queue and from the unverified count, because a status that cannot be established is not outstanding work.

Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.

Resolution: metadata only · nothing is hashed for this entry

Nothing is hashed for this entry. The concept paper is announced from the EMA GMP compliance page, which covers many documents, and no stable URL for the paper alone has been found — one candidate path returned 404. Tracked so the revision is visible; nothing is hashed and no status is read from a page describing several documents.

Authority
European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme
Jurisdiction
International
Status
not yet verified
Effective date
Last changed
Last verified
: not yet verified
Watch cadence
weekly
Crawlable
yes · renders server-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) ema.europa.eu — a listing covering several documents; no page describing this one has been found, so no status is read from it
Topics
data integrity · data management · GMP · consultation

Current status#

No status has been confirmed against the primary source. Recorded as unknown rather than estimated.

Observation history#

First observed 31 July 2026. Last observed 3 August 2026. 13 observation(s) recorded.

13 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.

What is not known#

The recorded source is a page listing several documents. No status is read from it, because a statement on that page may describe a different document.

The source was retrieved, but no phrase stating a regulatory status was found near a mention of this instrument.

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. EMA and PIC/S concept paper on the revision of GMP guidance on data management and integrity [instrument record]. Observed 3 August 2026. https://gxplex.com/instrument/ema-pics-data-integrity-concept Primary source: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice

BibTeX

@misc{gxplexinstrumentemapicsdataintegri,
  author       = {{GxPlex}},
  title        = {{EMA and PIC/S concept paper on the revision of GMP guidance on data management and integrity}},
  year         = {2026},
  note         = {instrument record, observed 3 August 2026},
  howpublished = {\url{https://gxplex.com/instrument/ema-pics-data-integrity-concept}},
  urldate      = {2026-08-03},
  url          = {https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice}
}

APA

GxPlex. (2026). EMA and PIC/S concept paper on the revision of GMP guidance on data management and integrity [instrument record]. Retrieved 3 August 2026, from https://gxplex.com/instrument/ema-pics-data-integrity-concept

Observation history

Observed on 13 occasion(s) since 2026-07-31. 13 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
208b17ec5cbe3dec1e28bfe934cbc4ff156555c20195553caf8f086f888783f0

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.

This document's title states no subject term this archive matches. That is a fact about the reading, not a subject it lacks — it is filed under no self-stated subject.

This document does not call itself a regulation, a guidance or a standard, so no class is recorded. It is filed under no self-stated class.

Sources