Generated Narrative: ValueSet cmc-comp-section-types-vs
http://terminology.hl7.org/CodeSystem/ICHContextOfUse| Code | Display |
| ich_3.2.s | m3.2.s drug substance |
| ich_3.2.s.1 | m3.2.s.1 general information |
| ich_3.2.s.2 | m3.2.s.2 manufacture |
| ich_3.2.s.2.1 | m3.2.s.2.1 manufacturer(s) |
| ich_3.2.s.2.2 | m3.2.s.2.2 description of manufacturing process and process controls |
| ich_3.2.s.2.3 | m3.2.s.2.3 control of materials |
| ich_3.2.s.2.4 | m3.2.s.2.4 controls of critical steps and intermediates |
| ich_3.2.s.2.5 | m3.2.s.2.5 process validation and/or evaluation |
| ich_3.2.s.2.6 | m3.2.s.2.6 manufacturing process development |
| ich_3.2.s.3 | m3.2.s.3 characterisation |
| ich_3.2.s.3.1 | m3.2.s.3.1 elucidation of structure and other characteristics |
| ich_3.2.s.3.2 | m3.2.s.3.2 impurities |
| ich_3.2.s.4 | m3.2.s.4 control of drug substance |
| ich_3.2.s.4.1 | m3.2.s.4.1 specification |
| ich_3.2.s.4.2 | m3.2.s.4.2 analytical procedures |
| ich_3.2.s.4.3 | m3.2.s.4.3 validation of analytical procedures |
| ich_3.2.s.4.4 | m3.2.s.4.4 batch analyses |
| ich_3.2.s.4.5 | m3.2.s.4.5 justification of specification |
| ich_3.2.s.5 | m3.2.s.5 reference standards or materials |
| ich_3.2.s.6 | m3.2.s.6 container closure system |
| ich_3.2.s.7 | m3.2.s.7 stability |
| ich_3.2.s.7.1 | m3.2.s.7.1 stability summary and conclusions |
| ich_3.2.s.7.2 | m3.2.s.7.2 post-approval stability protocol and stability commitment |
| ich_3.2.s.7.3 | m3.2.s.7.3 stability data |
| ich_3.2.p | m3.2.p drug product |
| ich_3.2.p.1 | m3.2.p.1 description and composition of the drug product |
| ich_3.2.p.2 | m3.2.p.2 pharmaceutical development |
| ich_3.2.p.2.1 | m3.2.p.2.1 components of the drug product |
| ich_3.2.p.2.2 | m3.2.p.2.2 drug product |
| ich_3.2.p.2.3 | m3.2.p.2.3 manufacturing process development |
| ich_3.2.p.2.4 | m3.2.p.2.4 container closure system |
| ich_3.2.p.2.5 | m3.2.p.2.5 microbiological attributes |
| ich_3.2.p.2.6 | m3.2.p.2.6 compatibility |
| ich_3.2.p.3 | m3.2.p.3 manufacture |
| ich_3.2.p.3.1 | m3.2.p.3.1 manufacturer(s) |
| ich_3.2.p.3.2 | m3.2.p.3.2 batch formula |
| ich_3.2.p.3.3 | m3.2.p.3.3 description of manufacturing process and process controls |
| ich_3.2.p.3.4 | m3.2.p.3.4 controls of critical steps and intermediates |
| ich_3.2.p.3.5 | m3.2.p.3.5 process validation and/or evaluation |
| ich_3.2.p.4 | m3.2.p.4 control of excipients |
| ich_3.2.p.4.1 | m3.2.p.4.1 specifications |
| ich_3.2.p.4.2 | m3.2.p.4.2 analytical procedures |
| ich_3.2.p.4.3 | m3.2.p.4.3 validation of analytical procedures |
| ich_3.2.p.4.4 | m3.2.p.4.4 justification of specifications |
| ich_3.2.p.4.5 | m3.2.p.4.5 excipients of human or animal origin |
| ich_3.2.p.4.6 | m3.2.p.4.6 novel excipients |
| ich_3.2.p.5 | m3.2.p.5 control of drug product |
| ich_3.2.p.5.1 | m3.2.p.5.1 specification(s) |
| ich_3.2.p.5.2 | m3.2.p.5.2 analytical procedures |
| ich_3.2.p.5.3 | m3.2.p.5.3 validation of analytical procedures |
| ich_3.2.p.5.4 | m3.2.p.5.4 batch analyses |
| ich_3.2.p.5.5 | m3.2.p.5.5 characterisation of impurities |
| ich_3.2.p.5.6 | m3.2.p.5.6 justification of specifications |
| ich_3.2.p.6 | m3.2.p.6 reference standards or materials |
| ich_3.2.p.7 | m3.2.p.7 container closure system |
| ich_3.2.p.8 | m3.2.p.8 stability |
| ich_3.2.p.8.1 | m3.2.p.8.1 stability summary and conclusion |
| ich_3.2.p.8.2 | m3.2.p.8.2 post-approval stability protocol and stability commitment |
| ich_3.2.p.8.3 | m3.2.p.8.3 stability data |
| ich_3.2.a | m3.2.a appendices |
| ich_3.2.a.1 | m3.2.a.1 facilities and equipment |
| ich_3.2.a.2 | m3.2.a.2 adventitious agents safety evaluation |
| ich_3.2.a.3 | m3.2.a.3 excipients |
| ich_3.2.r | m3.2 r regional information |
| ich_3.3 | m3.3 literature references |