GxPlex

ICH Q12

ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

final

Last verified: Last observed: no observation recorded Tier: 1 · Sector: pharma
Authority
International Council for Harmonisation
Jurisdiction
International
Status
final
Effective date
—
Last changed
—
Last verified
:
Watch cadence
quarterly
Crawlable
partial · renders client-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) ich.org
Topics
lifecycle management · established conditions

Current status#

Recorded as final against the primary source on 2026-07-29. See the evidence record for the text that supported it.

Scope#

ICH guideline introducing established conditions and post-approval change management protocols for lifecycle management.

Key dates#

No dates have been verified against the primary source for this entry.

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. ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [instrument record]. Observed 28 July 2026. https://gxplex.com/instrument/ich-q12 Primary source: https://ich.org/page/quality-guidelines

BibTeX

@misc{gxplexinstrumentichq12,
  author       = {{GxPlex}},
  title        = {{ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management}},
  year         = {2026},
  note         = {instrument record, observed 28 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/ich-q12}},
  urldate      = {2026-07-29},
  url          = {https://ich.org/page/quality-guidelines}
}

APA

GxPlex. (2026). ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [instrument record]. Retrieved 28 July 2026, from https://gxplex.com/instrument/ich-q12

Observation history

No observations recorded yet.

Change history

Sources

Last updated: