GxP documentation refers to the controlled documents and records required to demonstrate compliance with Good Practice (GxP) regulations, including GMP, GDP, GLP, and GCP. It ensures data integrity, product quality, patient safety, and regulatory compliance.
What Is GxP Documentation?
GxP documentation provides evidence that regulated processes are defined, followed, and controlled according to Good Practice requirements. It is essential for organisations operating in pharmaceutical, biotech, medical device, and life sciences industries.
What Is GxP Documentation?
GxP documentation includes policies, procedures, records, logs, and reports that support compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). These documents demonstrate consistent, compliant operations across the product lifecycle.
Why GxP Documentation Is Important
- Ensures patient safety and product quality
- Demonstrates compliance with regulatory authorities
- Maintains data integrity and traceability
- Supports audits, inspections, and certifications
Common GxP Documentation Examples
- Standard Operating Procedures (SOPs)
- Batch records and manufacturing logs
- Validation and qualification documentation
- Training records and deviation reports
Where GxP Documentation Is Required
- Pharmaceutical and biotechnology companies
- Medical device manufacturers
- Clinical research organisations (CROs)
- Laboratories and regulated life sciences operations
Manual vs Digital GxP Documentation
- Manual documentation: Paper-based records prone to errors and compliance risk
- Digital documentation: Controlled systems with version control, audit trails, and access controls
How GxP Documentation Supports Compliance
GxP documentation provides verifiable evidence that regulated processes are executed as approved. Regulators rely on controlled documentation, approval history, and audit trails to assess compliance with GxP requirements.
Next Steps for Organisations
- Identify processes governed by GxP regulations.
- Standardise templates and approval workflows.
- Implement a document management system designed for GxP compliance.
Learn how modern document management platforms support GxP documentation by exploring document management software features, book a demo, or contact our team.
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Frequently Asked Questions
What does GxP stand for?
GxP stands for Good Practice and includes regulations such as GMP, GDP, GLP, and GCP that govern regulated industries.
Is GxP documentation mandatory?
Yes. Organisations operating under GxP regulations must maintain controlled documentation to demonstrate compliance.
What happens if GxP documentation is incomplete?
Incomplete GxP documentation can result in audit findings, regulatory actions, product recalls, or operational shutdowns.
Can GxP documentation be automated?
Yes. Modern document management systems automate version control, approvals, audit trails, and access control for GxP documentation.
