ISO 11616:2017
ISO 11616:2017 is a compliance framework with 7 domains and 17 controls. The largest domains are Identification strata and levels – ISO 11616:2017 (5 controls), Pharmaceutical product identifier elements – ISO 11616:2017 (4 controls), Association with medicinal product identifiers – ISO 11616:2017 (2 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (7)
Association with medicinal product identifiers – ISO 11616:2017
| Code | Title |
|---|---|
| iso-11616-2017::8.1 | Concepts for MPID and PCID association with PhPIDs |
| iso-11616-2017::8.2 | Pharmaceutical product identification criteria |
Conceptual model – ISO 11616:2017
| Code | Title |
|---|---|
| iso-11616-2017::10 | Conceptual model |
Identification strata and levels – ISO 11616:2017
| Code | Title |
|---|---|
| iso-11616-2017::7.1 | Pharmaceutical product identification strata and levels |
| iso-11616-2017::7.1.2 | PhPID specified substance |
| iso-11616-2017::7.1.3 | Pharmaceutical product specified substance identification |
| iso-11616-2017::7.2 | Cardinality |
| iso-11616-2017::7.3 | Representation of strength concentration |
Investigational products – ISO 11616:2017
| Code | Title |
|---|---|
| iso-11616-2017::9 | Relationship between IMPID and IPCID and the PhPID |
Modelling principles – ISO 11616:2017
| Code | Title |
|---|---|
| iso-11616-2017::6.1 | General modelling considerations |
| iso-11616-2017::6.4 | Detailed description diagrams and relationships |
Pharmaceutical product identifier elements – ISO 11616:2017
| Code | Title |
|---|---|
| iso-11616-2017::7.4 | Pharmaceutical product identifier (PhPID) |
| iso-11616-2017::7.5 | Substance stratum elements |
| iso-11616-2017::7.6 | Specified substance stratum elements |
| iso-11616-2017::7.7 | Identifying characteristics to express strength |
Requirements for identification and exchange – ISO 11616:2017
| Code | Title |
|---|---|
| iso-11616-2017::5.1 | Elements required for unique identification |
| iso-11616-2017::5.2 | Exchange of pharmaceutical product information |
What is ISO 11616:2017 and who does it apply to?
ISO 11616:2017 is a compliance framework with 7 domains and 17 controls. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does ISO 11616:2017 actually require?
ISO 11616:2017 has 17 controls organised across 7 domains. The largest domains are Identification strata and levels – ISO 11616:2017 (5 controls), Pharmaceutical product identifier elements – ISO 11616:2017 (4 controls), Association with medicinal product identifiers – ISO 11616:2017 (2 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of ISO 11616:2017 do I already cover?
ISO 11616:2017 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement ISO 11616:2017?
Start your ISO 11616:2017 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 11616:2017 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 17 controls and track your progress.
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