What are the Regulations and Requirements for GLP Archiving?

May, 2024 | GLP Archiving

In the life sciences industry, public trust in the safety and efficacy of regulated products is upheld through the standards set by Good Laboratory Practices (GLP). Developed by the Organization for Economic Co-operation and Development (OECD), GLP principles provide a framework for ensuring the quality and reliability of non-clinical health and environmental safety studies. 

But GLP isn’t just about conducting the studies themselves; it also emphasizes the importance of proper archiving. There are specific GLP principles that govern archiving and how they impact life science research. 

The Importance of Archiving in GLP 

If groundbreaking research findings cannot be verified because the underlying data is lost or inaccessible, the entire study is invalid. This is precisely what GLP archiving safeguards against. By mandating proper archiving practices, the OECD ensures several key benefits: 

Regulatory Confidence: Regulatory bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) often rely on GLP studies for product approvals. Proper archiving allows them to conduct thorough inspections and verify the conduct and findings of these studies, upholding the highest standards for public health. 

Data Integrity is Maintained: GLP archiving fosters a complete audit trail, meticulously documenting every step of the research process. This transparency promotes data integrity and strengthens the reliability of research conclusions, fostering trust in the scientific community. 

Future Research Empowered: Archived data serves as a treasure trove for future research endeavors. If new questions arise about a product’s safety years later, researchers can refer to the original study data, gleaning valuable insights and potentially accelerating future discoveries. 

What Needs to be Archived 

According to OECD principles, all study documentation like procedures/protocols, raw data, reports, regulated material and samples, and other relevant information needs to be archived. The period of time varies depending on the regulations, but a typical period is 10-15 years. 

Key OECD GLP Principles for Archiving 

The OECD GLP principles provide a framework that allows researchers to utilize various technologies and archiving methods while maintaining the core principles of data integrity. Here’s a closer look at some key points: 

Format Agnostic: The principles apply to both paper-based and electronic data. Regardless of format, the focus is on ensuring data security, accessibility, and readability throughout the archiving period. 

Chain of Custody: Documented procedures are crucial for tracking the movement and ownership of samples and data throughout the study.  This meticulous chain of custody fosters trust and ensures the validity of research findings. Examples of regulations that emphasize chain of custody include the US EPA’s Good Laboratory Practice Regulations (40 CFR Part 160) and the European Union’s Directive 2004/10/EC (GLP Directive). 

Security and Access Control: Archived data, whether physical records or electronic files, must be protected from unauthorized access or modification.  This includes robust physical security measures for physical records and stringent access control protocols for electronic data, as outlined in regulations like the FDA’s 21 CFR Part 11 on Electronic Records and Signatures. 

Verifiable Format: All archived records, regardless of format, should be maintainable and accessible even as technology evolves.  This may involve using standardized formats or employing conversion strategies to ensure long-term accessibility. 

Retention on Record: While the OECD doesn’t dictate a universal archiving period, it emphasizes retaining data for a period that meets regulatory requirements and allows for future reference. National and regional regulations often dictate specific retention times.  For instance, the FDA’s GLP regulations typically require data retention for at least two years after the marketing approval of a product or until marketing rights are no longer pursued. 

Beyond the OECD: National and Regional Regulations 

It’s important to remember that many countries have adopted or adapted the OECD GLP principles into their own national regulations.  These national regulations may include additional or more specific requirements for GLP archiving. 

For instance, the FDA (USA) has its own GLP regulations outlined in 21 CFR Part 58, which mirror many OECD principles but may have specific nuances regarding data storage and retrieval practices.  Staying informed about these national and regional regulations is crucial for ensuring compliance and staying ahead of audits. 

Specific Requirements 

There are too many requirements to list, but GLP archiving spans across all categories including audit trail, backup and recovery, electronic signature, compliance, hardware, software, security, training, and more. Here’s a look at some of the key documents to understand: 

  • OECD M No. 17 
  • OECD M No. 22 
  • FDA 21 CFR Part 11 
  • FDA 21 CFR Part 13 
  • ISO 9001 
  • GAMP 5 2 Edition 
  • EMA Annex 11 

Note that this is not a comprehensive list of regulations to follow. GLP archivers may also follow best practices from ISBER, CAP, SQA, and their own standard operating procedures. Many of the above documents also have updated editions and supplements to keep up with. Following the regulations is of the utmost importance for GLP archiving and maintaining the validity of non-clinical research. 

Join Professional Local Chapters  

When it comes to regional regulations and compliance, it’s helpful to join the local chapters of life sciences professionals to stay abreast of quality assurance practices and changes in the market. 

In addition to complying with national and regional regulations, GXP-Storage is involved in the following local chapters: 

  • IFMA: International Facility Management Association 
  • ISBER: International Society for Biological and Environmental Repositories 
  • ISPE: International Society for Pharmaceutical Engineering 
  • SQA: Society of Quality Assurance 

Conclusion: Building Trust Through Archiving Excellence 

By following the OECD GLP principles and adhering to specific national regulations, life science companies can build a strong foundation for trust and transparency. Implementing best practices for GLP archiving ensures the integrity of research data, facilitates future scientific endeavors, and ultimately paves the way for the development of safe and effective products for human, animal, and agricultural health. 

GXP-Storage takes care of compliant GLP Archiving solutions so you don’t have to. We specialize in purpose-built regulated storage facilities along with our 21 CFR Part 11 compliant validated inventory management system: GXP-Guardian℠.   

 

Sources & Additional Resources: 

GXP-Storage offers compliant GxP solutions tailored to meet your requirements.

With decades of combined experience, we specialize in offering scalable storage solutions in our purpose-built restricted access facilities along with our 21 CFR Part 11 compliant validated inventory management system: GXP-Guardian℠. To learn about how we can help you consolidate and manage your research and manufacturing material, contact us or download our information sheet below.

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