What is GLP Archiving and Why is it Important?

May, 2024 | GLP Archiving

Good Laboratory Practices (GLP) are essential for ensuring the safety and efficacy of new products in the life sciences industry. These regulations ensure the quality and integrity of research, data, and samples generated in studies on chemicals, drugs, and other products meant for human, animal, or agricultural use. 

This development of new regulated products must follow Good Laboratory Practices (GLP) during all phases of product development from discovery to research and safety.  These studies, which require a significant investment of resources, generate valuable data, biological samples, and intellectual property for the sponsor. 

GLP archiving is the practice of retaining and managing the data, regulated material, and intellectual property generated from GLP studies for new product development. 

Why is GLP Archiving Important? 

Regulatory Compliance: Regulatory agencies like the FDA (USA) and EMA (EU) define how GLP studies are planned, conducted, recorded, and reported. GLP archiving covers the critical facets of recording and reporting. Effective GLP archiving ensures data and samples are readily available for audits and inspections. Without complete GLP compliance, a new product won’t be approved to advance to clinical trials and/or regulated manufacturing, marketing, and distribution. 

Prove Safety & Efficacy: GLP archiving safeguards the integrity of research data, fostering trust in scientific findings, and protecting public health. Proper GLP archiving allows a sponsor to further advance new products towards the approval of a safe and efficacious product.  

Manage Intellectual Property: Sponsors invest significant resources in the early identification and development of a new regulated product. GLP archiving protects this intellectual property by ensuring the secure storage and retrievability of valuable data and samples. Centralized GLP archives allow researchers to accelerate research progress. 

Challenges of GLP Archiving in Life Sciences: 

Non-Verified Custody & Inventory Records: Siloed regulated material storage and record keeping make it almost impossible to have a holistic view of GLP study materials and ensure a complete chain of custody. This lack of transparency can also raise doubts about data integrity and trigger deeper audits. 

Increasing Cost & Compliance Risks: Managing scattered regulated material across multiple providers is expensive and labor-intensive. The risk of losing or misplacing this material raises compliance concerns. In addition, costs increase with each new study, facility, and contractor. 

Poor Visibility & Slow Retrieval: Finding specific records or biological samples in diverse locations is time-consuming and may result in damaging regulatory inspection findings. If requested regulated material is eventually found, retrieval can take weeks. Rapid retrieval is crucial for research, audit, and other business licensing activities. 

The Path Forward: Embracing Modern GLP Archiving Solutions 

Centralized Archiving: Consolidating GLP materials in a centralized, secure facility streamlines data management, visibility, and retrieval. Partnering with a GLP archive storage provider offers scalable storage capacity across a variety of controlled environments without needing to manage multiple facilities or vendors. 

Validated Systems: Utilizing validated electronic archiving systems ensures data security and simplifies access control. The shipping, management, and security of regulated material should be controlled by a GLP compliant, audit-ready system that allows visibility into inventory without needing to reach out to customer service. 

Chain of Custody: Maintaining a documented chain of custody for data and samples guarantees their traceability and integrity. A validated system removes the need for paper and clipboards as chain of custody is archived throughout the whole lifecycle of the material. When materials are comprehensively tracked, rapid retrieval is a reality. 

Summary 

GLP studies in new product development are held to the highest standards, and GLP archiving requires a strategic plan that prioritizes data security, accessibility, and compliance.  Implementing a centralized, GLP-compliant archive with robust technology and validated procedures optimizes research efficiency, safeguards scientific integrity, and empowers continued innovation in the life sciences.  

 

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.

Talk to a GXP-Storage expert. We offer confidential consulations to assess your needs and design a tailored solution.

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To learn about how we can help you manage your regulated research and manufacturing material, download our information sheet.

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