Key Considerations When Selecting a Working Reference Standard
A well-qualified working reference standard (WRS) is the cornerstone of consistent analytical testing in pharmaceutical and biopharmaceutical manufacturing. But before qualification begins, choosing the right candidate material is a critical first step—one that directly impacts the reliability of analytical methods and the quality of finished products.
Why WRS Selection Matters
The accuracy of your analytical results depends on the integrity of the standard used. If the WRS material is unstable, impure, or inconsistent across batches, even the most robust qualification protocol won’t save your lab from variability issues down the line. That’s why careful selection of the source material—whether derived from a commercial reference standard, batch of API, or in-house material—is so vital.
Key Criteria to Evaluate
When selecting a working reference standard, here are several criteria to keep in mind:
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Purity and Potency: The selected material must be of known, documented purity and appropriate strength for its intended analytical use.
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Homogeneity: Ensure that the material is uniform throughout, minimizing lot-to-lot variability.
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Stability: Choose a compound that is physically and chemically stable under the storage and usage conditions expected throughout its lifespan.
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Availability: Ideally, the source material should be available in sufficient quantity for qualification, requalification, and potential bridging studies.
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Traceability: Documentation of origin, manufacturing, and prior test results should be readily available and verifiable.
Role of a Biopharma Consultant in WRS Selection
Selecting and qualifying a WRS is not just a laboratory task—it’s a strategic decision with regulatory implications. An experienced biopharma consultant can assist with WRS planning, sourcing, and method alignment while ensuring that your protocols remain compliant with current FDA, USP, and ICH guidance.
Whether you’re managing a new product launch or maintaining ongoing production, pharma consulting companies with deep experience in analytical development can help mitigate risk and ensure testing integrity.
Bridging to WRS Qualification
Once a suitable candidate is selected, the next step is formal qualification. If you’re ready to move forward, be sure to read our full post on Creating Working Reference Standard (WRS) Qualification Protocols, where we cover the key elements of a scientifically sound and regulator-ready approach.
Article by:
Christopher M. LeBlanc
Founder & Principal Consultant
Christopher LeBlanc is the founder and Principal Consultant of BioPharma Consulting Group, LLC, a patient passionate, innovative consulting agency that provides quality services to the Biotechnology, Pharmaceutical and Gene Therapy industries.
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