EudraLex Volume 4, Chapter 4 — Documentation
Chapter 4 describes expectations for the generation, control, review, approval, distribution, maintenance, and retention of GMP documentation and records, including paper, electronic, photographic, and other media.
What the authority record establishes
Chapter 4 describes expectations for the generation, control, review, approval, distribution, maintenance, and retention of GMP documentation and records, including paper, electronic, photographic, and other media.
Official GMP guidance applied within the EU medicinal-product legal framework
The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.
Why it matters to this market
Controlled content, executed records, metadata, review, retention, and retrieval are foundational eQMS concerns. Buyers must distinguish document-authoring convenience from regulated record control and maintain awareness of the pending revision path.
Affected operating stages
- Document Creation
- Review And Approval
- Issuance And Distribution
- Record Execution
- Correction And Change
- Retention And Retrieval
- Archival And Disposal
Capabilities to examine
Controlled Documents
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for controlled documents.
Training Management
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for training management.
Quality Events And Deviations
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for quality events and deviations.
CAPA
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for CAPA.
Change Control
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for change control.
Audit And Inspection Management
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for audit and inspection management.
Computerized-System Validation Support
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for computerized-system validation support.
Affected buyer audiences
- EU medicinal-product manufacturers and importers
- quality assurance and document-control teams
- contract manufacturers and laboratories
- computerized-system owners
- records-management teams
Implementation questions
- Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
- What is binding, what is guidance, and what is a technical or consensus standard?
- Which publication, adoption, effective, application, transition, and enforcement dates differ?
- Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
- How will a source revision affect open work and historical decisions?
Interpretation boundary
The 2025 consultation proposed revisions but did not itself replace the operative chapter. Product claims should be evaluated against current requirements and separately against likely future design implications.