Bundle bundle-drug-product-compatibility-pq-ex1 of type collection

Entry 1 - fullUrl = urn:uuid:1e1e1e1e-1e1e-1e1e-1e1e-1e1e1e1e1e1e

Resource MedicinalProductDefinition:

Language: en

Profile: MedicinalProductDefinition - Drug Product PQ

identifier: http://example.org/identifiers/product/PROD-12345

combinedPharmaceuticalDoseForm: Tablet

route: Oral use

Names

-	ProductName	Type
*	Stelbatolol 10mg Tablets	Invented Name

Entry 2 - fullUrl = urn:uuid:2e2e2e2e-2e2e-2e2e-2e2e-2e2e2e2e2e2e

Resource Medication:

Language: en

Profile: Medication - Batch Information Drug PQ

code:

batch

Medication Manufacturing Batch

url

manufacturingDate

value: 2020-06

url

batchQuantity

value: 100100 tablets

url

batchUtilization

value: Production

url

assignedManufacturer

value: Organization AAA Molybdenum Products, Inc.

closureSystemDescription: 100 cc HDPE Bottle 2 g desiccant

url

container

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Designation PQ: Maximum

Extension - Batch Number of Vials PQ: 3

Extension - Batch Substance Batch PQ: Substance

Extension - Packaging Date PQ: 2020-08

Extension - Packaging Site PQ: Organization AAA Molybdenum Products, Inc.

Extension - Actual Yield PQ: 4.81 kg

Extension - Actual Yield Unfiltered PQ: 4.91 kg

Extension Target Fill Weight PQ: 30 g

lotNumber: 33445

Entry 3 - fullUrl = urn:uuid:3e3e3e3e-3e3e-3e3e-3e3e-3e3e3e3e3e3e

Resource PlanDefinition:

Metadata
Title	Stability Monitoring Program
Subject Type	MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use
Description	Narrative description of Stability Study
Type	Stability Study Protocol
PlanDefinition Action
Title	Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg
PlanDefinition Sub-Action (Parent Action Title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg)
Title	Long-Term
Description	25°C/60% RH
PlanDefinition Sub-Action (Parent Action Title: Long-Term)
Title	Initial
Timing	Once
PlanDefinition Sub-Action (Parent Action Title: Initial)
Title	XYZ
Definition	http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90
Generated using version 0.5.4 of the sample-content-ig Liquid templates

Entry 4 - fullUrl = urn:uuid:4e4e4e4e-4e4e-4e4e-4e4e-4e4e4e4e4e4e

Resource ObservationDefinition:

Language: en

Profile: ObservationDefinition - Test Method PQ

status: Active

code: Assay

method: Assay by UHPLC

Entry 5 - fullUrl = urn:uuid:5e5e5e5e-5e5e-5e5e-5e5e-5e5e5e5e5e5e

Resource DiagnosticReport:

Language: en

Profile: DiagnosticReport - Analysis Drug PQ

Stability Study Report - 18 months

When For	2020-12
Performer	Organization AAA Molybdenum Products, Inc.
Identifier	https://eudract.europa.eu/example/identifier/ABC1234

Report Details

Code	Value	Flags	When For
Test Components - Long-term 25C etc - Initial (XYZ)		Final	2023-01-01 12:00:00+0000

The samples have been assessed for initial period; no shelf life determined.

Entry 6 - fullUrl = urn:uuid:6e6e6e6e-6e6e-6e6e-6e6e-6e6e6e6e6e6e

Resource Observation:

Language: en

Profile: Observation - Test Result Drug PQ

Triggered by: Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.

status: Final

code: Test Components - Long-term 25C etc - Initial (XYZ)

subject: Medication

effective: 2023-01-01 12:00:00+0000

performer: Organization AAA Molybdenum Products, Inc.

specimen: Specimen

hasMember:

• Observation Description
• Observation Degradation Products
• Observation Degradation Products
• Observation Degradation Products
• Observation Degradation Products
• Observation Degradation Products
• Observation Water Content
• Observation Microbiological Quality
• Observation Uniformity of dosage units (by weight)

Entry 7 - fullUrl = urn:uuid:7e7e7e7e-7e7e-7e7e-7e7e-7e7e7e7e7e7e

Resource Organization:

Language: en

Profile: Organization - Drug PQ

identifier: FDA Establishment Identifier/3003040516

active: true

type: Drug Substance Manufacture

name: AAA Molybdenum Products, Inc.

Contacts

-	Address
*	7233 W 116th Pl Ste C Broomfield Colorado 80020 USA