Key Considerations for Maintaining Qualified Working Standards Over Time

For a detailed overview of how to develop and qualify a working reference standard, refer to our working standard qualification protocols guide.

Why Maintenance Matters

Once a working standard is put into use, factors such as degradation, contamination, or inconsistent handling can jeopardize its reliability. If left unchecked, this could result in inaccurate test results, product deviations, or even regulatory citations during inspections.

By implementing a structured maintenance plan, organizations can:

• Extend the usable life of the working standard

• Ensure consistency across analytical batches

• Maintain compliance with regulatory expectations

• Detect issues before they affect product quality

Best Practices for Lifecycle Management

To preserve the integrity of your working standards over time, consider the following strategies:

1. Controlled Storage Conditions

Maintain documented, validated storage conditions aligned with the material’s known stability profile. Use temperature and humidity monitoring devices, and establish alarm systems for any deviations.

2. Defined Requalification Schedule

Set a scientifically justified requalification interval, based on data from your initial qualification and any ongoing stability studies. Include clear criteria for extending or retiring the standard.

3. Routine Visual and Analytical Checks

Regularly inspect for physical changes (e.g., discoloration, clumping) and perform periodic retesting to confirm continued suitability.

4. Robust Documentation and Traceability

Track all usage, storage conditions, and test results in a controlled document system. Ensure that analysts know how to access the current status of the working standard at any time.

5. Training and SOP Adherence

Ensure your team is properly trained on handling and documentation procedures, and that your SOPs are clear, accessible, and updated as needed.

How Biopharma Consulting Supports Ongoing Quality

Maintaining qualified working standards is a cross-functional task that requires collaboration between Quality Assurance, Analytical Development, and Operations. Organizations looking to scale or formalize these practices often benefit from working with a trusted biopharma consulting partner.

Expert consultants can:

• Audit existing standard management programs

• Develop or update SOPs

• Design requalification protocols

• Train staff on best practices and regulatory expectations

Conclusion
Establishing a working standard is only half the battle—the real work lies in maintaining its qualified status throughout its lifecycle. With the right controls, documentation, and support, you can ensure your standards remain reliable and inspection-ready for as long as they’re in use.

For more insights, visit our cornerstone post on creating working reference standard qualification protocols.