10 Things to Verify in Your SmPC Translation Workflow Ahead of Upcoming QRD Template Update (v11)
The QRD Template is more than a formatting framework. It defines how SmPC content is structured and aligned across multilingual regulatory submissions. Upcoming QRD updates provide a valuable opportunity to review translation workflows and identify areas where consistency, compliance, and process control can be strengthened.
In regulated product information, even minor inconsistencies can affect package leaflets, labelling, regulatory submissions, and country-specific materials. The risks extend beyond language quality and may impact version control, terminology management, document consistency, traceability, and regulatory readiness.
The following checklist highlights ten areas worth reviewing before your next update cycle.
1. Source text control
Question:
Are all teams working from the latest approved SmPC version under a controlled version management system?
What to check:
Verify that a single approved source document is used as the basis for translation. Confirm that translators, reviewers, regulatory teams, and local stakeholders have access to the same version, including the relevant version number, approval status, and change history. Clear version control helps prevent outdated content from entering the translation workflow or being translated.
2. QRD terminology alignment
Question:
Are standard QRD headings, section titles, and terminology aligned with the latest QRD requirements and official language versions?
What to check:
Review whether mandatory QRD headings, standard phrases, and approved terminology are applied consistently across all target languages. Check that validated wording is maintained in terminology resources, translation memories, or approved reference materials and is reused where appropriate.
3. Country-specific language requirements
Question:
Are local linguistic, legal, and regulatory requirements embedded into the workflow for each target market?
What to check:
Ensure that country-specific requirements are identified before translation begins. This may include local terminology preferences, mandatory wording, abbreviations, units, formatting conventions, and national regulatory expectations. Linguists should have visibility of these requirements from the outset.
4. Change visibility and management
Question:
Can translators and reviewers clearly identify changes compared to the previous approved version?
What to check:
Confirm that updated content is provided with tracked changes, comparison files, or detailed change logs. Translators and reviewers should be able to distinguish between new, modified, and unchanged content to reduce review effort and minimize the risk of overlooked updates.
5. Standard phrase reuse
Question:
Does the workflow ensure systematic reuse of approved QRD phrases and validated wording?
What to check:
Review how approved phrases, standard QRD wording, and previously validated translations are managed and reused. Consistent phrase reuse supports harmonization across SmPCs, package leaflets, labelling, and related regulatory documents while reducing unnecessary retranslation.
6. Formatting and structural checks
Question:
Are headings, numbering, tables, cross-references, units, symbols, and abbreviations systematically verified before submission?
What to check:
Review whether translated files preserve the structure of the source document. Particular attention should be paid to tables, numbering, references, units of measure, special characters, abbreviations, and document navigation elements that may be affected during translation or formatting.
7. Independent linguistic QA
Question:
Is there an independent linguistic QA step, ideally performed by a qualified linguist not involved in the initial translation?
What to check:
Ensure that a qualified reviewer performs a final linguistic quality review separate from the initial translation process. Whenever possible, this reviewer should not have been involved in the initial translation in order to provide an objective assessment.
8. Terminology consistency across deliverables
Question:
Is terminology consistently aligned across all related documents, including SmPCs, package leaflets, labelling, and regulatory materials?
What to check:
Review whether key terms, product information, and approved wording remain consistent across all document types. Inconsistencies between related deliverables can create confusion, increase review effort, and trigger regulatory questions.
9. Traceability of decisions
Question:
Is there full documentation of translation and regulatory decisions throughout the workflow?
What to check:
Verify that translation choices, terminology decisions, review comments, and regulatory updates are documented and retained. Decision records should be accessible, understandable, and retrievable throughout the product lifecycle to support audits and inspections.
10. Final regulatory compliance check
Question:
Is there a final end-to-end review confirming alignment with QRD requirements and applicable local regulations?
What to check:
Confirm that all deliverables undergo a final compliance review before submission. This should verify alignment with applicable QRD requirements, country-specific expectations, approved terminology, formatting standards, and internal quality procedures.
Why this matters
Translation quality alone is not enough for regulated product information. Successful multilingual submissions depend on controlled workflows, terminology governance, structured quality assurance, and full traceability throughout the document lifecycle.
As regulatory requirements evolve, organizations that proactively review their translation workflows are better positioned to maintain consistency across markets, reduce operational risk, and support efficient submission processes.
At Janus Worldwide, we support pharmaceutical and biotechnology companies with multilingual translation workflows for SmPCs, package leaflets, labelling, and related regulatory content. Our Life Sciences teams combine regulatory expertise, terminology management, structured quality assurance, and controlled delivery processes to help ensure accuracy and consistency across languages and markets.
If your organization is planning updates to SmPCs, package leaflets, or labelling, now may be a good time to assess whether your translation workflow is prepared for the next regulatory update cycle.
Talk to our Life Sciences translation experts today to assess your current workflow and find practical ways to improve regulatory readiness.