Pharmaceutical Quality (Industry)
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Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Batch Formula: synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.3 Manufacture, subsection 3.2.P.3.2 Batch Formula.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

Bundle [documentation R4 R5 R6]
id: bundle-batch-formula-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-formula-pq
Type: collection
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stalbatolol
Name type: Proprietary [Proprietary] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example)


Batch Formula : Large Batch of Stelbatolol
The batch quantities shown represent the full scale manufacturing process for which the batch size is approximately 130 kg, producing approximately 722000 tablets.

mg/tablet Kg/batch
Active Ingredient:
Stelbatolol 15.2 10.98
Other Ingredients:
Mannitol 145.0 104.72
Maize starch 13.8 9.98
Calcium carboxymethylcellulose 4.0 2.90
Magnesium stearate 2.0 1.44
Total Weight 180.0 130.0


Batch Formula : Small Batch of Stelbatolol
The batch quantities shown represent the full scale manufacturing process for which the batch size is approximately 65 kg, producing approximately 371000 tablets.

mg/tablet Kg/batch
Active Ingredient:
Stelbatolol 15.2 5.98
Other Ingredients:
Mannitol 145.0 52.36
Maize starch 13.8 5.99
Calcium carboxymethylcellulose 4.0 1.45
Magnesium stearate 2.0 0.72
Total Weight 180.0 66.5

Ingredient - Active [100000072072] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: ingredient1
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a65
Status: active
Role: Active [100000072072] (http://hl7.org/fhir/ingredient-role)
Substance
Found a parent (Ingredient/code, id: ingredient1 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a65)
which is linked to this by resource.id
Found a parent (Substance/code, id: substanceIngredient-1 fullUrl: (none))
which is linked to this by resource.id
Found a parent (Substance/code, id: substanceIngredient-1 fullUrl: (none))
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substance1
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474
Name: Stelbatolol
Display: Stelbatolol
Strength
Presentation Strength: 15.2 mg per 1 tablet
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient1
fullUrl: urn:uuid:b89fd9d2-80f9-0cfb-70a1-5a6572e73a65
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Substance
Display: Mannitol
Strength
Presentation Strength: 145.0 mg per 1 tablet
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient2
fullUrl: urn:uuid:b89ed9d2-81f9-0cfb-70a1-5a6572e73a65
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Substance
Display: Maize starch
Strength
Presentation Strength: 13.8 mg per 1 tablet
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient3
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a66
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Substance
Display: Calcium carboxymethylcellulose
Strength
Presentation Strength: 4.0 mg per 1 tablet
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient4
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70b1-5a6572e73a66
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Substance
Display: Magnesium stearate
Strength
Presentation Strength: 2.0 mg per 1 tablet
Batch Instance
↸arrow indicates that this Medication resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via extension http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
Medication [documentation R4 R5 R6]
id: medication-batch-formula-unlinked
fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070
Code: Large Batch of Stelbatolol
Definition: Stalbatolol (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceIngredient-1
fullUrl: (none)
Instance: false
Definition: Stelbatolol (SubstanceDefinition) id: substance1
Active ingredient: true
Strength - Quantity: 10.98 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-1
fullUrl: (none)
Instance: false
Definition:
Display: Mannitol
Active ingredient: false
Strength - Quantity: 104.72 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-2
fullUrl: (none)
Instance: false
Definition:
Display: Maize starch
Active ingredient: false
Strength - Quantity: 9.98 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-3
fullUrl: (none)
Instance: false
Definition:
Display: Calcium carboxymethylcellulose
Active ingredient: false
Strength - Quantity: 2.90 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-4
fullUrl: (none)
Instance: false
Definition:
Display: Magnesium stearate
Active ingredient: false
Strength - Quantity: 1.44 kg
Batch
Manufacturing
Quantity: 130 kg
Items: 722000 tablets
↸arrow indicates that this Medication resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via extension http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
Medication [documentation R4 R5 R6]
id: medication-batch-formula-2-unlinked
fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071
Code: Small Batch of Stelbatolol
Definition: Stalbatolol (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceIngredient-1
fullUrl: (none)
Instance: false
Definition: Stelbatolol (SubstanceDefinition) id: substance1
Active ingredient: true
Strength - Quantity: 5.98 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-1
fullUrl: (none)
Instance: false
Definition:
Display: Mannitol
Active ingredient: false
Strength - Quantity: 52.36 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-2
fullUrl: (none)
Instance: false
Definition:
Display: Maize starch
Active ingredient: false
Strength - Quantity: 5.99 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-3
fullUrl: (none)
Instance: false
Definition:
Display: Calcium carboxymethylcellulose
Active ingredient: false
Strength - Quantity: 1.45 kg
Ingredient
Found a parent (Medication/item, id: medication-batch-formula-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11070)
which is linked to this by contained resource.id
Found a parent (Medication/item, id: medication-batch-formula-2-unlinked fullUrl: urn:uuid:bf17176f-9779-180b-5c59-e58cddc11071)
which is linked to this by contained resource.id
Substance [documentation R4 R5 R6]
id: substanceExcipient-4
fullUrl: (none)
Instance: false
Definition:
Display: Magnesium stearate
Active ingredient: false
Strength - Quantity: 0.72 kg
Batch
Manufacturing
Quantity: 65 kg
Items: 371000 tablets