Links a CTD table-of-contents heading to the document(s) placed under it. Module 1 codes are regionally defined; Modules 2-5 are ICH-defined.
|
HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
|
Term
Term Description as defined by the Health Authority
|
Code
Code, if any, associated with the term by the Health Authority
|
Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
|
Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
|
|---|---|---|---|---|
| ICH Context of Use | m3.2.p.3.3 description of manufacturing process and process controls |
ich_3.2.p.3.3
|
ICH | Active |
| ICH Context of Use | m3.2.p.3.4 controls of critical steps and intermediates |
ich_3.2.p.3.4
|
ICH | Active |
| ICH Context of Use | m3.2.p.3.5 process validation and/or evaluation |
ich_3.2.p.3.5
|
ICH | Active |
| ICH Context of Use | m3.2.p.4 control of excipients |
ich_3.2.p.4
|
ICH | Active |
| ICH Context of Use | m3.2.p.4.1 specifications |
ich_3.2.p.4.1
|
ICH | Active |
| ICH Context of Use | m3.2.p.4.2 analytical procedures |
ich_3.2.p.4.2
|
ICH | Active |
| ICH Context of Use | m3.2.p.4.3 validation of analytical procedures |
ich_3.2.p.4.3
|
ICH | Active |
| ICH Context of Use | m3.2.p.4.4 justification of specifications |
ich_3.2.p.4.4
|
ICH | Active |
| ICH Context of Use | m3.2.p.4.5 excipients of human or animal origin |
ich_3.2.p.4.5
|
ICH | Active |
| ICH Context of Use | m3.2.p.4.6 novel excipients |
ich_3.2.p.4.6
|
ICH | Active |
| ICH Context of Use | m3.2.p.5 control of drug product |
ich_3.2.p.5
|
ICH | Active |
| ICH Context of Use | m3.2.p.5.1 specification(s) |
ich_3.2.p.5.1
|
ICH | Active |
| ICH Context of Use | m3.2.p.5.2 analytical procedures |
ich_3.2.p.5.2
|
ICH | Active |
| ICH Context of Use | m3.2.p.5.3 validation of analytical procedures |
ich_3.2.p.5.3
|
ICH | Active |
| ICH Context of Use | m3.2.p.5.4 batch analyses |
ich_3.2.p.5.4
|
ICH | Active |
| ICH Context of Use | m3.2.p.5.5 characterisation of impurities |
ich_3.2.p.5.5
|
ICH | Active |
| ICH Context of Use | m3.2.p.5.6 justification of specifications |
ich_3.2.p.5.6
|
ICH | Active |
| ICH Context of Use | m3.2.p.6 reference standards or materials |
ich_3.2.p.6
|
ICH | Active |
| ICH Context of Use | m3.2.p.7 container closure system |
ich_3.2.p.7
|
ICH | Active |
| ICH Context of Use | m3.2.p.8 stability |
ich_3.2.p.8
|
ICH | Active |
| ICH Context of Use | m3.2.p.8.1 stability summary and conclusion |
ich_3.2.p.8.1
|
ICH | Active |
| ICH Context of Use | m3.2.p.8.2 post-approval stability protocol and stability commitment |
ich_3.2.p.8.2
|
ICH | Active |
| ICH Context of Use | m3.2.p.8.3 stability data |
ich_3.2.p.8.3
|
ICH | Active |
| ICH Context of Use | m3.2.s drug substance |
ich_3.2.s
|
ICH | Active |
| ICH Context of Use | m3.2.s.1 general information |
ich_3.2.s.1
|
ICH | Active |
Showing 276–300 of 380 terms . Data sourced from public health authority publications and updated periodically.