-
Notifications
You must be signed in to change notification settings - Fork 7
/
FHIR-us-pq-cmc.xml
239 lines (239 loc) · 35.6 KB
/
FHIR-us-pq-cmc.xml
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
<?xml version="1.0" encoding="UTF-8"?>
<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/us/pq-cmc-fda/2024May" ciUrl="https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda" defaultVersion="1.0.0-ballot" defaultWorkgroup="brr" gitUrl="https://github.com/HL7/FHIR-us-pq-cmc" url="http://hl7.org/fhir/us/pq-cmc-fda">
<version code="current" url="https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda"/>
<version code="1.0.0-ballot" url="http://hl7.org/fhir/us/pq-cmc-fda/2024May"/>
<artifactPageExtension value="-definitions"/>
<artifactPageExtension value="-examples"/>
<artifactPageExtension value="-mappings"/>
<artifact id="SubstanceDefinition/278736ef-2ddf-49e4-895c-3a9f34db36cf" key="SubstanceDefinition-278736ef-2ddf-49e4-895c-3a9f34db36cf" name="278736ef-2ddf-49e4-895c-3a9f34db36cf"/>
<artifact id="Bundle/32532fe8-1bfb-4a0a-998d-9294742a9519" key="Bundle-32532fe8-1bfb-4a0a-998d-9294742a9519" name="32532fe8-1bfb-4a0a-998d-9294742a9519"/>
<artifact id="Organization/37a26b1a-ede3-4677-943e-72b513f945b7" key="Organization-37a26b1a-ede3-4677-943e-72b513f945b7" name="37a26b1a-ede3-4677-943e-72b513f945b7"/>
<artifact id="Organization/48beec35-843c-42f5-9251-7aa6fd693199" key="Organization-48beec35-843c-42f5-9251-7aa6fd693199" name="48beec35-843c-42f5-9251-7aa6fd693199"/>
<artifact id="SubstanceDefinition/55f2bbea-1a2d-4240-aef0-bc1a76b39212" key="SubstanceDefinition-55f2bbea-1a2d-4240-aef0-bc1a76b39212" name="55f2bbea-1a2d-4240-aef0-bc1a76b39212"/>
<artifact id="SubstanceDefinition/58ae52aa-c81e-415a-8791-e67a3195290d" key="SubstanceDefinition-58ae52aa-c81e-415a-8791-e67a3195290d" name="58ae52aa-c81e-415a-8791-e67a3195290d"/>
<artifact id="MedicinalProductDefinition/6248d2ea-c9e0-4280-9beb-08b7041071c2" key="MedicinalProductDefinition-6248d2ea-c9e0-4280-9beb-08b7041071c2" name="6248d2ea-c9e0-4280-9beb-08b7041071c2"/>
<artifact id="Bundle/7cdbb042-9275-4599-a1fe-08877846bf94" key="Bundle-7cdbb042-9275-4599-a1fe-08877846bf94" name="7cdbb042-9275-4599-a1fe-08877846bf94"/>
<artifact id="SubstanceDefinition/7f7c63b0-8ad8-4529-b000-bf4b6c384558" key="SubstanceDefinition-7f7c63b0-8ad8-4529-b000-bf4b6c384558" name="7f7c63b0-8ad8-4529-b000-bf4b6c384558"/>
<artifact id="SubstanceDefinition/8202d18a-df68-4cbd-912d-59c7cff5cfa6" key="SubstanceDefinition-8202d18a-df68-4cbd-912d-59c7cff5cfa6" name="8202d18a-df68-4cbd-912d-59c7cff5cfa6"/>
<artifact id="Organization/98effc99-db2b-428d-89aa-0ce426e02788" key="Organization-98effc99-db2b-428d-89aa-0ce426e02788" name="98effc99-db2b-428d-89aa-0ce426e02788"/>
<artifact id="Bundle/9e8f2d16-66b1-47ec-878d-f50ae021985b" key="Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b" name="9e8f2d16-66b1-47ec-878d-f50ae021985b"/>
<artifact deprecated="true" id="MedicinalProductDefinition/77ad6922-9c59-43d1-93cb-29d063cc2e8c" key="MedicinalProductDefinition-77ad6922-9c59-43d1-93cb-29d063cc2e8c" name="A DrugProductContainerClosure"/>
<artifact id="MedicinalProductDefinition/5772a6f2-cde1-4903-bfcf-1639340205cc" key="MedicinalProductDefinition-5772a6f2-cde1-4903-bfcf-1639340205cc" name="A DrugProductDescription for a multilayer product"/>
<artifact id="ManufacturedItemDefinition/a8316fc9-8ca8-4115-81c1-9f8f84c99149" key="ManufacturedItemDefinition-a8316fc9-8ca8-4115-81c1-9f8f84c99149" name="A FinishedProduct profile based on ManufacturedItemDefinition"/>
<artifact id="PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7" key="PlanDefinition-aa514363-d43f-4052-b44e-b67aa4d6dee7" name="A quality specification is for a drug product"/>
<artifact id="PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93" key="PlanDefinition-cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93" name="A quality specification is for a drug substance"/>
<artifact id="SubstanceDefinition/cbb54715-3928-4e3f-9abe-32914f694957" key="SubstanceDefinition-cbb54715-3928-4e3f-9abe-32914f694957" name="API used in two layer table example"/>
<artifact id="StructureDefinition/pq-additional-info-extension" key="StructureDefinition-pq-additional-info-extension" name="Additional Information"/>
<artifact id="StructureDefinition/pq-amount-ratio" key="StructureDefinition-pq-amount-ratio" name="Amount Ratio"/>
<artifact id="StructureDefinition/pqcmc-graphic-attachment" key="StructureDefinition-pqcmc-graphic-attachment" name="Analysis Graphic"/>
<artifact id="StructureDefinition/pqcmc-analytical-intstrument-data" key="StructureDefinition-pqcmc-analytical-intstrument-data" name="Analytical Instrument Data"/>
<artifact id="ValueSet/pqcmc-analytical-instrument-data-types" key="ValueSet-pqcmc-analytical-instrument-data-types" name="Analytical Instrument Data File Types"/>
<artifact id="DocumentReference/22bd989e-8056-494f-9bc1-195d13428179" key="DocumentReference-22bd989e-8056-494f-9bc1-195d13428179" name="Base64 Document Reference - L-thyroxine-3D-structure-CT1000583834.sdf"/>
<artifact id="DocumentReference/d94ad7ac-b935-432f-bc68-312b6b8dcca7" key="DocumentReference-d94ad7ac-b935-432f-bc68-312b6b8dcca7" name="Base64 Document Reference - Levothyroid.png"/>
<artifact id="DocumentReference/0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3" key="DocumentReference-0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3" name="Base64 Document Reference - Monosodium_D-thyroxine_hydrate.png"/>
<artifact id="StructureDefinition/cmc-organization" key="StructureDefinition-cmc-organization" name="Basic Organization"/>
<artifact id="StructureDefinition/pqcmc-batch-formula-product" key="StructureDefinition-pqcmc-batch-formula-product" name="Batch Formula Drug Product Identification"/>
<artifact id="MedicinalProductDefinition/d0d2df25-5cfa-4417-b8d1-b8147957f53c" key="MedicinalProductDefinition-d0d2df25-5cfa-4417-b8d1-b8147957f53c" name="Batch Formula Drug Product Identification"/>
<artifact id="MedicinalProductDefinition/f0f3ff35-5cfa-6617-b8f1-b8167957f53c" key="MedicinalProductDefinition-f0f3ff35-5cfa-6617-b8f1-b8167957f53c" name="Batch Formula Drug Product Identification 2 layer"/>
<artifact id="ManufacturedItemDefinition/8a3e11d9-4323-43c4-be00-8f0ea1837070" key="ManufacturedItemDefinition-8a3e11d9-4323-43c4-be00-8f0ea1837070" name="Batch Formula for 2 layer tablet"/>
<artifact id="ManufacturedItemDefinition/249ef22b-d521-4304-a388-6b9035f97b22" key="ManufacturedItemDefinition-249ef22b-d521-4304-a388-6b9035f97b22" name="Batch Formula for Oxazepam / Propranolol-Hydrochloride product"/>
<artifact id="ValueSet/pqcmc-batch-utilization-terminology" key="ValueSet-pqcmc-batch-utilization-terminology" name="Batch utilization Terminology"/>
<artifact id="Bundle/30536c0e-456c-4f90-9f02-da7be1d289e9" key="Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9" name="Bundle for 3.2.S.1"/>
<artifact id="StructureDefinition/cmc-ectd-document-32p10" key="StructureDefinition-cmc-ectd-document-32p10" name="CMC eCTD 32P10 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-32p32" key="StructureDefinition-cmc-ectd-document-32p32" name="CMC eCTD 32P32 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-32p55" key="StructureDefinition-cmc-ectd-document-32p55" name="CMC eCTD 32P55 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-32s10" key="StructureDefinition-cmc-ectd-document-32s10" name="CMC eCTD 32S10 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-32s23" key="StructureDefinition-cmc-ectd-document-32s23" name="CMC eCTD 32S23 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-32s3" key="StructureDefinition-cmc-ectd-document-32s3" name="CMC eCTD 32S3 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-sp4151" key="StructureDefinition-cmc-ectd-document-sp4151" name="CMC eCTD SP4151 Document"/>
<artifact id="Bundle/bd0f0a7a-27ea-4884-801d-bd0546e80888" key="Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888" name="CMCeCTDDocument32P10 bundle"/>
<artifact id="ValueSet/capsule-classification-category" key="ValueSet-capsule-classification-category" name="Capsule Shell Classification Terminology"/>
<artifact id="PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e" key="PlanDefinition-ab241f8c-d21e-4382-a70a-52190dbdf07e" name="Carrageenan specification Example"/>
<artifact id="ValueSet/pqcmc-chemical-structure-datafile-type-terminology" key="ValueSet-pqcmc-chemical-structure-datafile-type-terminology" name="Chemical Structure Data File Type Terminology"/>
<artifact id="PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b" key="PlanDefinition-a2cba634-a481-4b07-9bd4-62c7ada31e1b" name="Citric acid specification Example"/>
<artifact id="ValueSet/pqcmc-closure-type-terminology" key="ValueSet-pqcmc-closure-type-terminology" name="Closure Type Terminology"/>
<artifact id="ValueSet/pqcmc-coating-purpose" key="ValueSet-pqcmc-coating-purpose" name="Coating Purpose Terminology"/>
<artifact id="Composition/4bd1ed57-852b-42be-a9b0-355f8a2aa7d4" key="Composition-4bd1ed57-852b-42be-a9b0-355f8a2aa7d4" name="Cochineal specification Composition Example"/>
<artifact id="PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e" key="PlanDefinition-37bf5cc0-33bf-478b-b84e-ccb35143ef6e" name="Cochineal specification Example"/>
<artifact id="CodeSystem/pqcmc-comp-section-types" key="CodeSystem-pqcmc-comp-section-types" name="Code System PQCMC Comp Section Types"/>
<artifact id="Organization/4f3e9af1-306b-4fad-bf04-7881400b266a" key="Organization-4f3e9af1-306b-4fad-bf04-7881400b266a" name="CodedOrganization - Wunderwerke"/>
<artifact id="Organization/49438799-e286-432c-b8d8-68ac77e7f519" key="Organization-49438799-e286-432c-b8d8-68ac77e7f519" name="CodedOrganization J. Jones Research"/>
<artifact id="StructureDefinition/pqcmc-component-substance" key="StructureDefinition-pqcmc-component-substance" name="Component Substance"/>
<artifact id="SubstanceDefinition/393a14e7-3edc-4373-bbe5-9e569d504a1c" key="SubstanceDefinition-393a14e7-3edc-4373-bbe5-9e569d504a1c" name="Composition ingredient substance indentifying information - Maize starch"/>
<artifact id="SubstanceDefinition/fc878c4f-a98c-427c-816b-e03ccdf0e712" key="SubstanceDefinition-fc878c4f-a98c-427c-816b-e03ccdf0e712" name="Composition ingredient substance indentifying information - acetaminophen"/>
<artifact id="SubstanceDefinition/2d70d504-8cc6-4282-81d4-b20b0a98b78b" key="SubstanceDefinition-2d70d504-8cc6-4282-81d4-b20b0a98b78b" name="Composition ingredient substance indentifying information - aspirin"/>
<artifact id="ValueSet/pqcmc-conformance-to-criteria-terminology" key="ValueSet-pqcmc-conformance-to-criteria-terminology" name="Conformance to Criteria Terminology"/>
<artifact deprecated="true" id="StructureDefinition/pq-container-closure-extension" key="StructureDefinition-pq-container-closure-extension" name="Container Closure"/>
<artifact id="DocumentReference/928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b" key="DocumentReference-928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b" name="Container Closure Attached Document example"/>
<artifact id="ValueSet/pqcmc-container-type-terminology" key="ValueSet-pqcmc-container-type-terminology" name="Container Type Terminology"/>
<artifact id="StructureDefinition/ContainerClosure" key="StructureDefinition-ContainerClosure" name="ContainerClosure"/>
<artifact deprecated="true" id="StructureDefinition/content-percent" key="StructureDefinition-content-percent" name="Content Percent"/>
<artifact id="StructureDefinition/cmc-document-reference" key="StructureDefinition-cmc-document-reference" name="Document Reference Attachment"/>
<artifact id="Organization/e165f057-5eed-4e64-8328-4438fc88fb1b" key="Organization-e165f057-5eed-4e64-8328-4438fc88fb1b" name="Drug Manufacturing Site - Vandechemie"/>
<artifact id="StructureDefinition/pqcmc-product-batch-formula" key="StructureDefinition-pqcmc-product-batch-formula" name="Drug Product Batch Formula"/>
<artifact id="StructureDefinition/pqcmc-dp-ingredient" key="StructureDefinition-pqcmc-dp-ingredient" name="Drug Product Batch Formula Ingredient"/>
<artifact id="StructureDefinition/pqcmc-component" key="StructureDefinition-pqcmc-component" name="Drug Product Component"/>
<artifact id="ValueSet/pqcmc-drug-product-component-function-category-terminology" key="ValueSet-pqcmc-drug-product-component-function-category-terminology" name="Drug Product Component Function Category Terminology"/>
<artifact deprecated="true" id="StructureDefinition/pqcmc-drugproduct-container-closure" key="StructureDefinition-pqcmc-drugproduct-container-closure" name="Drug Product Container Closure"/>
<artifact id="StructureDefinition/pqcmc-drug-product-description" key="StructureDefinition-pqcmc-drug-product-description" name="Drug Product Description"/>
<artifact id="StructureDefinition/pqcmc-drug-product-handle" key="StructureDefinition-pqcmc-drug-product-handle" name="Drug Product Handle"/>
<artifact id="StructureDefinition/pqcmc-drug-product-with-impurities" key="StructureDefinition-pqcmc-drug-product-with-impurities" name="Drug Product Impurities"/>
<artifact id="ValueSet/spl-drug-route-of-administration-terminology" key="ValueSet-spl-drug-route-of-administration-terminology" name="Drug Route Of Administration Terminology"/>
<artifact id="StructureDefinition/pqcmc-drug-substance-characterisation" key="StructureDefinition-pqcmc-drug-substance-characterisation" name="Drug Substance"/>
<artifact id="StructureDefinition/pqcmc-routine-drug-substance" key="StructureDefinition-pqcmc-routine-drug-substance" name="Drug Substance Handle"/>
<artifact id="StructureDefinition/pqcmc-drug-product-substance-impurity" key="StructureDefinition-pqcmc-drug-product-substance-impurity" name="Drug Substance Impurity"/>
<artifact id="SubstanceDefinition/21b6b724-507e-4cf4-a462-93334b98d166" key="SubstanceDefinition-21b6b724-507e-4cf4-a462-93334b98d166" name="Drug Substance Nomenclature and Structure"/>
<artifact id="Ingredient/d01421cc-6488-468b-a676-d3e7281875e2" key="Ingredient-d01421cc-6488-468b-a676-d3e7281875e2" name="DrugProductComponent example for an excipient - Maize starch"/>
<artifact deprecated="true" id="CodeSystem/cmc-ema-dummy" key="CodeSystem-cmc-ema-dummy" name="Dummy EMA Codesystem"/>
<artifact deprecated="true" id="ValueSet/evmpd-substance-classification" key="ValueSet-evmpd-substance-classification" name="EVMPD Substance Classification"/>
<artifact id="Organization/e875ef93-a730-4c44-bead-53663ae7f501" key="Organization-e875ef93-a730-4c44-bead-53663ae7f501" name="East-West Manufacturing"/>
<artifact id="Composition/5dfbbf17-05c0-441d-af66-7a66072f4ae4" key="Composition-5dfbbf17-05c0-441d-af66-7a66072f4ae4" name="EctdComposition32P10 for 2 layer tablet"/>
<artifact id="Ingredient/95648837-ec81-42d9-970c-eac390f2f604" key="Ingredient-95648837-ec81-42d9-970c-eac390f2f604" name="Example 2-layer batch formula ingredient - Water"/>
<artifact id="SubstanceDefinition/254742fb-7b5b-49f5-b4af-e0d14d81f2f6" key="SubstanceDefinition-254742fb-7b5b-49f5-b4af-e0d14d81f2f6" name="Example 2-layer batch formula ingredient substance - Water"/>
<artifact id="Ingredient/d4713a90-38d1-49e5-a977-78c63e518562" key="Ingredient-d4713a90-38d1-49e5-a977-78c63e518562" name="Example Asprin Ingredient"/>
<artifact id="Ingredient/1c1a2a23-1fd7-4487-9682-49877f9f9f77" key="Ingredient-1c1a2a23-1fd7-4487-9682-49877f9f9f77" name="Example AtomexetineHydrochloride"/>
<artifact id="Bundle/49d3b79e-b436-a242-93ba-b706b4364ab2" key="Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2" name="Example Batch Formula bundle"/>
<artifact id="Bundle/a242b79e-b706-49d3-93ba-b4364ab2baa3" key="Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3" name="Example Batch Formula bundle"/>
<artifact id="Composition/0003c00b-bfc2-4775-8b1c-9f99d5cf1f39" key="Composition-0003c00b-bfc2-4775-8b1c-9f99d5cf1f39" name="Example Composition 3.2.P.3.2"/>
<artifact id="Composition/c00b0003-c2bf-7547-8b1c-f1f399f99d5c" key="Composition-c00b0003-c2bf-7547-8b1c-f1f399f99d5c" name="Example Composition 3.2.P.3.2 two layer tablet"/>
<artifact id="Composition/5c0d341e-6e4f-457c-811d-cfaf3eb62ecd" key="Composition-5c0d341e-6e4f-457c-811d-cfaf3eb62ecd" name="Example Composition for CTD 3.2.S.2.3"/>
<artifact id="PackagedProductDefinition/77ad6922-9c59-43d1-93cb-29d063cc2e8c" key="PackagedProductDefinition-77ad6922-9c59-43d1-93cb-29d063cc2e8c" name="Example Container Closure"/>
<artifact deprecated="true" id="SubstanceDefinition/5f66b17e-e3c0-4ee4-8106-59faa34d70f7" key="SubstanceDefinition-5f66b17e-e3c0-4ee4-8106-59faa34d70f7" name="Example RoutineSubstanceDefinition"/>
<artifact id="SubstanceDefinition/0efb1188-04f0-44ba-bfe7-ca6169ca8703" key="SubstanceDefinition-d8242262-2187-4ea2-907f-b66752202b46" name="Example SubstanceDefinition for Carrageenan"/>
<artifact id="SubstanceDefinition/fd84a8b5-9e96-451c-a5c6-097c943eb38a" key="SubstanceDefinition-fd84a8b5-9e96-451c-a5c6-097c943eb38a" name="Example SubstanceDefinition for anhydrous citric acid"/>
<artifact id="SubstanceDefinition/d3a11b25-e160-4688-b807-6383364096fd" key="SubstanceDefinition-d3a11b25-e160-4688-b807-6383364096fd" name="Example SubstanceDefinition for water"/>
<artifact id="SubstanceDefinition/717d868e-6696-4ebb-adf4-63eadb3bf058" key="SubstanceDefinition-717d868e-6696-4ebb-adf4-63eadb3bf058" name="Example SubstanceDefinition- ATOMOXETINE HYDROCHLORIDE"/>
<artifact id="SubstanceDefinition/580c28ac-1a2c-49fa-9be3-de997da5edcf" key="SubstanceDefinition-580c28ac-1a2c-49fa-9be3-de997da5edcf" name="Example SubstanceDefinitionHandle - IBUPROFEN"/>
<artifact id="SubstanceDefinition/cd84a8b5-4e96-551c-15c6-c97c943eb38a" key="SubstanceDefinition-cd84a8b5-4e96-551c-15c6-c97c943eb38a" name="Example SubstanceDefinitionHandle for Asprin"/>
<artifact id="Ingredient/fbd464cc-2511-4a3a-b058-3cec4fffd14f" key="Ingredient-fbd464cc-2511-4a3a-b058-3cec4fffd14f" name="Example batch formula ingredient - Acetaminophen"/>
<artifact id="Ingredient/12cce82f-8595-4860-b7ca-06c9ec0327f2" key="Ingredient-12cce82f-8595-4860-b7ca-06c9ec0327f2" name="Example batch formula ingredient - Acetic Acid"/>
<artifact id="Ingredient/4e394a0c-4b25-492e-aac7-0faf121ffc4f" key="Ingredient-4e394a0c-4b25-492e-aac7-0faf121ffc4f" name="Example batch formula ingredient - Grape skinn"/>
<artifact id="Ingredient/9973ba9a-b257-425a-8fb9-6dcfe379ca08" key="Ingredient-9973ba9a-b257-425a-8fb9-6dcfe379ca08" name="Example batch formula ingredient - Maize starch"/>
<artifact id="Ingredient/29c0ee76-f62f-41d3-b761-73d5f205e552" key="Ingredient-29c0ee76-f62f-41d3-b761-73d5f205e552" name="Example batch formula ingredient - Mannitol"/>
<artifact id="Ingredient/44fad9fd-826a-4f0c-9f25-e0a78d1c4269" key="Ingredient-44fad9fd-826a-4f0c-9f25-e0a78d1c4269" name="Example batch formula ingredient - Metacresol"/>
<artifact id="Ingredient/45eb4f05-83d9-4819-bb60-96c7c5ce2b76" key="Ingredient-45eb4f05-83d9-4819-bb60-96c7c5ce2b76" name="Example batch formula ingredient - Sodium Acetate Anhydrous"/>
<artifact id="Ingredient/d0574580-7694-4a36-8a27-5bdbccfc5557" key="Ingredient-d0574580-7694-4a36-8a27-5bdbccfc5557" name="Example batch formula ingredient - Water"/>
<artifact id="SubstanceDefinition/45942749-64db-4f91-88c3-51adb680fed1" key="SubstanceDefinition-45942749-64db-4f91-88c3-51adb680fed1" name="Example batch formula ingredient substance - Acetic Acid"/>
<artifact id="SubstanceDefinition/a339a562-e325-4ce6-a830-d25c27b5e2da" key="SubstanceDefinition-a339a562-e325-4ce6-a830-d25c27b5e2da" name="Example batch formula ingredient substance - MANNITOL"/>
<artifact id="SubstanceDefinition/c75df5fb-e962-43a6-9dd3-c6682da10a7e" key="SubstanceDefinition-c75df5fb-e962-43a6-9dd3-c6682da10a7e" name="Example batch formula ingredient substance - METACRESOL"/>
<artifact id="SubstanceDefinition/07c598ee-3dcf-45b7-b4e5-b24812c22aff" key="SubstanceDefinition-07c598ee-3dcf-45b7-b4e5-b24812c22aff" name="Example batch formula ingredient substance - Sodium Acetate Anhydrous"/>
<artifact id="SubstanceDefinition/c4e5b7c6-2e52-48e3-813b-d227cf29329b" key="SubstanceDefinition-c4e5b7c6-2e52-48e3-813b-d227cf29329b" name="Example batch formula ingredient substance - Water"/>
<artifact id="Organization/8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9" key="Organization-8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9" name="Example of CodedOrganization profile on Organization"/>
<artifact id="Organization/d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" key="Organization-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" name="Example of a Supplier Organization"/>
<artifact id="StructureDefinition/pqcmc-excipient" key="StructureDefinition-pqcmc-excipient" name="Excipient Drug Substance"/>
<artifact id="ValueSet/pqcmc-excipient-function-terminology" key="ValueSet-pqcmc-excipient-function-terminology" name="Excipient Function Terminology"/>
<artifact id="Bundle/4a7e17c1-a611-4cc7-9a71-8005a8b427ab" key="Bundle-4a7e17c1-a611-4cc7-9a71-8005a8b427ab" name="FHIR Document example of 3.2.P.5.1."/>
<artifact id="Bundle/6004e36e-7df9-469d-9b29-8e9f9bd7e95f" key="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f" name="FHIR Document example of 3.2.S.4.1."/>
<artifact deprecated="true" id="ValueSet/genc-country-codes" key="ValueSet-genc-country-codes" name="GENC Country Code Values"/>
<artifact deprecated="true" id="CodeSystem/genc-country-codes-cs" key="CodeSystem-genc-country-codes-cs" name="GENC Country Codes"/>
<artifact id="StructureDefinition/pqcmc-graphic-reference" key="StructureDefinition-pqcmc-graphic-reference" name="Graphic Reference"/>
<artifact id="ValueSet/pqcmc-graphical-file-types" key="ValueSet-pqcmc-graphical-file-types" name="Graphical File Types"/>
<artifact id="StructureDefinition/pq-hierarchical-level-extension" key="StructureDefinition-pq-hierarchical-level-extension" name="Hierarchical Level"/>
<artifact deprecated="true" id="CodeSystem/pqcmc-test-category-codes" key="CodeSystem-pqcmc-test-category-codes" name="Hierarchical Test Category Codes"/>
<artifact deprecated="true" id="ConceptMap/ISOtoGENC" key="ConceptMap-ISOtoGENC" name="ISO to GENC Country Code Mapping"/>
<artifact id="ValueSet/pqcmc-impurity-classification-terminology" key="ValueSet-pqcmc-impurity-classification-terminology" name="Impurity Classification Terminology"/>
<artifact id="SubstanceDefinition/496f83ad-2365-4b12-8672-a349d99f7d67" key="SubstanceDefinition-496f83ad-2365-4b12-8672-a349d99f7d67" name="IngredComponentSubstance example showing the use of the sourceMaterial backbone element"/>
<artifact id="ValueSet/pqcmc-product-part-ingredient-physical-location" key="ValueSet-pqcmc-product-part-ingredient-physical-location" name="Ingredient Location Terminology"/>
<artifact id="SubstanceDefinition/a4624559-6c4f-4e90-996d-bc3bf2f5a3f4" key="SubstanceDefinition-a4624559-6c4f-4e90-996d-bc3bf2f5a3f4" name="Ingredient substance indentifying information - Grape skin extract"/>
<artifact id="SubstanceDefinition/99f4a24f-880f-45f1-8364-8e4e03977b2e" key="SubstanceDefinition-99f4a24f-880f-45f1-8364-8e4e03977b2e" name="Ingredient substance indentifying information - Maize starch"/>
<artifact id="SubstanceDefinition/ca1ff85f-3f05-46be-8cc4-30b076d88c13" key="SubstanceDefinition-ca1ff85f-3f05-46be-8cc4-30b076d88c13" name="Ingredient substance indentifying information - acetaminophen"/>
<artifact deprecated="true" id="StructureDefinition/pq-interpretation-code-extension" key="StructureDefinition-pq-interpretation-code-extension" name="Interpretation Code"/>
<artifact deprecated="true" id="ValueSet/pqcmc-interpretation-code-terminology" key="ValueSet-pqcmc-interpretation-code-terminology" name="Interpretation Code Terminology"/>
<artifact id="ValueSet/pqcmc-manufactured-dose-form-terminology" key="ValueSet-pqcmc-manufactured-dose-form-terminology" name="Manufactured Dose Form Terminology"/>
<artifact id="StructureDefinition/pqcmc-product-part" key="StructureDefinition-pqcmc-product-part" name="Manufactured Drug Product"/>
<artifact id="Organization/4b565cf3-5353-48af-8cd6-5ccf4e9fd579" key="Organization-4b565cf3-5353-48af-8cd6-5ccf4e9fd579" name="Manufacturing Site (J. Jones Research)"/>
<artifact deprecated="true" id="StructureDefinition/mfg-test-site-organization" key="StructureDefinition-mfg-test-site-organization" name="Manufacturing and/or Test Site Organization"/>
<artifact id="ValueSet/pqcmc-non-percentage-units" key="ValueSet-pqcmc-non-percentage-units" name="Non-Percentage Units"/>
<artifact deprecated="true" id="StructureDefinition/optional-denominator" key="StructureDefinition-optional-denominator" name="Optional Denominator"/>
<artifact id="ValueSet/pqcmc-org-identifier-type-terminology" key="ValueSet-pqcmc-org-identifier-type-terminology" name="Organization-Site Identifier Terminology"/>
<artifact id="CodeSystem/cmc-ncit-dummy" key="CodeSystem-cmc-ncit-dummy" name="PQ-CMC-FDA Temporary Codes"/>
<artifact id="StructureDefinition/pqcmc-attachment" key="StructureDefinition-pqcmc-attachment" name="PQCMC Attachment"/>
<artifact id="ValueSet/pqcmc-name-part-terminology" key="ValueSet-pqcmc-name-part-terminology" name="PQCMC Name Part Terminology"/>
<artifact id="ValueSet/pqcmc-product-characteristic" key="ValueSet-pqcmc-product-characteristic" name="PQCMC Product Characteristic"/>
<artifact id="ValueSet/pqcmc-percentage-units" key="ValueSet-pqcmc-percentage-units" name="Percentage Units"/>
<artifact id="ValueSet/spl-pharmaceutical-dosage-form-terminology" key="ValueSet-spl-pharmaceutical-dosage-form-terminology" name="Pharmaceutical Dosage Form Terminology"/>
<artifact id="StructureDefinition/pqcmc-polymorphic-form" key="StructureDefinition-pqcmc-polymorphic-form" name="Polymorphic Form"/>
<artifact id="SubstanceDefinition/832f22b4-6f0c-41f8-9b7d-f26f55e9973c" key="SubstanceDefinition-832f22b4-6f0c-41f8-9b7d-f26f55e9973c" name="Polymorphic Form Example"/>
<artifact id="StructureDefinition/pq-cmc-address" key="StructureDefinition-pq-cmc-address" name="PqAddress"/>
<artifact id="StructureDefinition/pq-product-batch-ingredient-extension" key="StructureDefinition-pq-product-batch-ingredient-extension" name="Product Batch Ingredient Extension"/>
<artifact id="CodeSystem/cmc-product-name-types" key="CodeSystem-cmc-product-name-types" name="Product Name Types Code Types"/>
<artifact id="ValueSet/cmc-product-name-types-vs" key="ValueSet-cmc-product-name-types-vs" name="Product Name Types Terminology"/>
<artifact id="ValueSet/pqcmc-product-part-type" key="ValueSet-pqcmc-product-part-type" name="Product Part Type Terminology"/>
<artifact deprecated="true" id="StructureDefinition/pq-ig-version" key="StructureDefinition-pq-ig-version" name="Profile IG Version"/>
<artifact id="ValueSet/pqcmc-quality-benchmark-terminology" key="ValueSet-pqcmc-quality-benchmark-terminology" name="Quality Benchmark Terminology"/>
<artifact id="StructureDefinition/pqcmc-quality-specification" key="StructureDefinition-pqcmc-quality-specification" name="Quality Specification"/>
<artifact id="CodeSystem/cmc-relationship-types" key="CodeSystem-cmc-relationship-types" name="Relationship Types Codes"/>
<artifact id="ValueSet/cmc-relationship-types-vs" key="ValueSet-cmc-relationship-types-vs" name="Relationship Types Terminology"/>
<artifact id="ValueSet/pqcmc-release-mechanism" key="ValueSet-pqcmc-release-mechanism" name="Release Mechanism Terminology"/>
<artifact id="ValueSet/pqcmc-release-profile" key="ValueSet-pqcmc-release-profile" name="Release Profile Terminology"/>
<artifact deprecated="true" id="StructureDefinition/pqcmc-routine-drug-product" key="StructureDefinition-pqcmc-routine-drug-product" name="Routine Drug Product"/>
<artifact id="ValueSet/pqcmc-source-type-terminology" key="ValueSet-pqcmc-source-type-terminology" name="Source Type Terminology"/>
<artifact id="ValueSet/cmc-specification-types-vs" key="ValueSet-cmc-specification-types-vs" name="Specification Section Type Terminology"/>
<artifact id="StructureDefinition/pq-specification-status-extension" key="StructureDefinition-pq-specification-status-extension" name="Specification Status"/>
<artifact id="ValueSet/pqcmc-specification-status-terminology" key="ValueSet-pqcmc-specification-status-terminology" name="Specification Status Terminology"/>
<artifact deprecated="true" id="StructureDefinition/pq-specification-type-extension" key="StructureDefinition-pq-specification-type-extension" name="Specification Type"/>
<artifact id="ValueSet/pqcmc-specification-type-terminology" key="ValueSet-pqcmc-specification-type-terminology" name="Specification Type Terminology"/>
<artifact deprecated="true" id="StructureDefinition/cmc-sponsor-organization" key="StructureDefinition-cmc-sponsor-organization" name="Sponsor Organization"/>
<artifact id="Organization/b69435a0-45c6-4d44-9fde-b354e17408d7" key="Organization-b69435a0-45c6-4d44-9fde-b354e17408d7" name="Sponsor of API"/>
<artifact id="StructureDefinition/strength-extension" key="StructureDefinition-strength-extension" name="Strength Extension"/>
<artifact deprecated="true" id="ValueSet/pqcmc-strength-operator-terminology" key="ValueSet-pqcmc-strength-operator-terminology" name="Strength Operator Terminology"/>
<artifact id="ValueSet/pqcmc-strength-type-terminology" key="ValueSet-pqcmc-strength-type-terminology" name="Strength Type Terminology"/>
<artifact id="Ingredient/fc09842a-8f71-48f2-9f9f-ff2441b2eb6f" key="Ingredient-fc09842a-8f71-48f2-9f9f-ff2441b2eb6f" name="Strength info for the Active Ingredient"/>
<artifact id="Ingredient/3791c4ce-2b43-4d7b-b195-0e5f88f28dab" key="Ingredient-3791c4ce-2b43-4d7b-b195-0e5f88f28dab" name="Strength information - Grape skin extract"/>
<artifact id="Ingredient/7f10a35e-228d-42db-8918-6ccada78454d" key="Ingredient-7f10a35e-228d-42db-8918-6ccada78454d" name="Strength information for the Active Ingredient - acetaminophen"/>
<artifact id="StructureDefinition/pqcmc-structure-data" key="StructureDefinition-pqcmc-structure-data" name="Structure Data"/>
<artifact id="StructureDefinition/pqcmc-structure-reference" key="StructureDefinition-pqcmc-structure-reference" name="Structure Data Reference"/>
<artifact id="ValueSet/pqcmc-structure-data-types" key="ValueSet-pqcmc-structure-data-types" name="Structure Data Types"/>
<artifact id="SubstanceDefinition/3419cdae-4d99-4068-bfaa-8037550bf327" key="SubstanceDefinition-3419cdae-4d99-4068-bfaa-8037550bf327" name="Substance Characterization - EthylAcetate"/>
<artifact id="Composition/d52acdbd-6881-495a-84a2-0dccf07ee5ab" key="Composition-d52acdbd-6881-495a-84a2-0dccf07ee5ab" name="Substance Characterization for EthylAcetate"/>
<artifact id="ValueSet/substance-classification" key="ValueSet-substance-classification" name="Substance Classification"/>
<artifact id="StructureDefinition/pqcmc-drug-substance-nomenclature-structure" key="StructureDefinition-pqcmc-drug-substance-nomenclature-structure" name="Substance General Information"/>
<artifact id="ValueSet/pqcmc-substance-name-type" key="ValueSet-pqcmc-substance-name-type" name="Substance Name Type"/>
<artifact deprecated="true" id="StructureDefinition/supplier-organization" key="StructureDefinition-supplier-organization" name="Supplier Organization"/>
<artifact id="StructureDefinition/pq-target-range" key="StructureDefinition-pq-target-range" name="Target Range"/>
<artifact id="ValueSet/pqcmc-test-category-terminology" key="ValueSet-pqcmc-test-category-terminology" name="Test Category Terminology"/>
<artifact id="ValueSet/pqcmc-test-method-origin-terminology" key="ValueSet-pqcmc-test-method-origin-terminology" name="Test Method Origin Terminology"/>
<artifact deprecated="true" id="StructureDefinition/pq-order-extension" key="StructureDefinition-pq-order-extension" name="Test Order | Stage Sequence Order"/>
<artifact id="ValueSet/pqcmc-test-usage-terminology" key="ValueSet-pqcmc-test-usage-terminology" name="Test Usage Terminology"/>
<artifact id="ValueSet/pqcmc-units-of-measure" key="ValueSet-pqcmc-units-of-measure" name="Units Of Measure"/>
<artifact deprecated="true" id="ValueSet/pqcmc-units-of-measure-terminology" key="ValueSet-pqcmc-units-of-measure-terminology" name="Units Of Measure Terminology"/>
<artifact id="Organization/e99bddfa-c1b5-435b-bbe8-24816b4e23e5" key="Organization-e99bddfa-c1b5-435b-bbe8-24816b4e23e5" name="Vidinaid"/>
<artifact id="PlanDefinition/5819b223-d3d2-419f-b617-b3a9a3625b89" key="PlanDefinition-5819b223-d3d2-419f-b617-b3a9a3625b89" name="Water Specification Example"/>
<artifact id="Bundle/a7a2d35b-5d9d-4a8c-b012-d04a07662c0a" key="Bundle-a7a2d35b-5d9d-4a8c-b012-d04a07662c0a" name="a7a2d35b-5d9d-4a8c-b012-d04a07662c0a"/>
<artifact id="SubstanceDefinition/ac7ac2da-df69-4ed9-b399-4dc40a71b332" key="SubstanceDefinition-ac7ac2da-df69-4ed9-b399-4dc40a71b332" name="ac7ac2da-df69-4ed9-b399-4dc40a71b332"/>
<artifact id="MedicinalProductDefinition/ddd3abad-347c-4d2f-95f3-dd804e250502" key="MedicinalProductDefinition-ddd3abad-347c-4d2f-95f3-dd804e250502" name="ddd3abad-347c-4d2f-95f3-dd804e250502"/>
<artifact id="DocumentReference/de75e338-626c-4503-a25d-4fcdd8e39bee" key="DocumentReference-de75e338-626c-4503-a25d-4fcdd8e39bee" name="de75e338-626c-4503-a25d-4fcdd8e39bee"/>
<artifact id="MedicinalProductDefinition/89676a69-1fe7-422c-ab00-92abe4ef6ea9" key="MedicinalProductDefinition-89676a69-1fe7-422c-ab00-92abe4ef6ea9" name="drug product for specification"/>
<artifact id="StructureDefinition/ectd-composition-32p32" key="StructureDefinition-ectd-composition-32p32" name="eCTD Batch Formula"/>
<artifact id="Composition/260f5aa3-23d2-4999-8e5f-70f247390ee5" key="Composition-260f5aa3-23d2-4999-8e5f-70f247390ee5" name="eCTD Composition for 3.2.S.1"/>
<artifact id="Bundle/7ce2088d-d281-4e2f-9a25-120a1f9805d1" key="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1" name="eCTD Document for 32S23"/>
<artifact id="Composition/55d92f43-e328-4011-bbcf-744e3afd954f" key="Composition-55d92f43-e328-4011-bbcf-744e3afd954f" name="eCTD Drug Substance Specification Composition SP4151"/>
<artifact id="Composition/45ec3ebc-ec1a-4b4d-bfc4-c50edc67f2ce" key="Composition-45ec3ebc-ec1a-4b4d-bfc4-c50edc67f2ce" name="eCTD Product Characterisation of Impurities"/>
<artifact id="StructureDefinition/ectd-composition-32p55" key="StructureDefinition-ectd-composition-32p55" name="eCTD Product Characterisation of Impurities Composition"/>
<artifact id="Composition/8a07e353-9cf6-4f27-8a30-2c2d4f439847" key="Composition-8a07e353-9cf6-4f27-8a30-2c2d4f439847" name="eCTD Product Characterisation of Impurities Composition for TabletCoatedBeadsCoatedAll"/>
<artifact id="StructureDefinition/ectd-composition-32p10" key="StructureDefinition-ectd-composition-32p10" name="eCTD Product Description and Composition"/>
<artifact id="Composition/d332acdf-4874-407b-9950-528f14c6bea2" key="Composition-d332acdf-4874-407b-9950-528f14c6bea2" name="eCTD Product Specification Composition SP4151"/>
<artifact id="StructureDefinition/ectd-composition-sp4151" key="StructureDefinition-ectd-composition-sp4151" name="eCTD Specification Composition"/>
<artifact id="StructureDefinition/ectd-composition-32s3" key="StructureDefinition-ectd-composition-32s3" name="eCTD Substance Characterisation"/>
<artifact id="StructureDefinition/ectd-composition-32s23" key="StructureDefinition-ectd-composition-32s23" name="eCTD Substance Control of Materials Composition"/>
<artifact id="StructureDefinition/ectd-composition-32s10" key="StructureDefinition-ectd-composition-32s10" name="eCTD Substance General Information"/>
<artifact id="ValueSet/cmc-comp-section-types-vs" key="ValueSet-cmc-comp-section-types-vs" name="eCTD sections Terminology"/>
<artifact id="Organization/f22ab70c-20c0-4ee4-848b-622b67ec8592" key="Organization-f22ab70c-20c0-4ee4-848b-622b67ec8592" name="f22ab70c-20c0-4ee4-848b-622b67ec8592"/>
<artifact id="SubstanceDefinition/ffa30c0b-8031-436a-87f1-635b3bbe5989" key="SubstanceDefinition-ffa30c0b-8031-436a-87f1-635b3bbe5989" name="ffa30c0b-8031-436a-87f1-635b3bbe5989"/>
<page key="NA" name="(NA)"/>
<page key="many" name="(many)"/>
<page deprecated="true" key="profiles" name="(profiles)"/>
<page key="artifacts" name="Artifact List"/>
<page key="change_notes" name="Change Notes"/>
<page key="eCTD32P10" name="Description and Composition of the Drug Product (3.2.P.1)"/>
<page key="downloads" name="Downloads"/>
<page key="eCTD32S10" name="General Information (3.2.S.1)"/>
<page key="instruction" name="General Instructions"/>
<page key="index" name="Home"/>
<page key="eCTD32P32" name="Product Batch Formula (3.2.P.3.2)"/>
<page key="eCTD32P55" name="Product Characterisation of Impurities (3.2.P.5.5)"/>
<page key="eCTDSP4151" name="Specification (3.2.S.4.1, 3.2.P.4 and 3.2.P.5.1)"/>
<page key="eCTD32S23" name="Substance Control of Materials (3.2.S.2.3)"/>
<page key="toc" name="Table of Contents"/>
<page key="eCTD32S3" name="eCTD Substance Characterisation (3.2.S.3)"/>
</specification>