GxPlex

ICH Q11

ICH Q11 — Development and Manufacture of Drug Substances

not yet verified

Last verified: not yet verified Last observed: no observation recorded Tier: 1 · Sector: pharma

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.

Authority
International Council for Harmonisation
Jurisdiction
International
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
quarterly
Crawlable
unknown
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) ich.org
Topics
quality guideline

Current status#

Status not yet verified against the primary source. Recorded as unknown rather than estimated.

Scope#

ICH quality guideline in the Q-series, addressing development and manufacture.

Key dates#

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

Sources#

NEEDS VERIFICATION. The regulatory status of this instrument has not yet been confirmed against its primary source. It is recorded as unknown rather than estimated. See /methodology for what verification means here.

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 Q11 — Development and Manufacture of Drug Substances [instrument record]. Observed 27 July 2026. https://gxplex.com/instrument/ich-q11 Primary source: https://ich.org/page/quality-guidelines

BibTeX

@misc{gxplexinstrumentichq11,
  author       = {{GxPlex}},
  title        = {{ICH Q11 — Development and Manufacture of Drug Substances}},
  year         = {2026},
  note         = {instrument record, observed 27 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/ich-q11}},
  urldate      = {2026-07-28},
  url          = {https://ich.org/page/quality-guidelines}
}

APA

GxPlex. (2026). ICH Q11 — Development and Manufacture of Drug Substances [instrument record]. Retrieved 27 July 2026, from https://gxplex.com/instrument/ich-q11

Observation history

No observations recorded yet.

Sources