by Jeffrey Wotton | May 2, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Key Considerations for Maintaining Qualified Working Standards Over Time Establishing a qualified working standard is only the beginning of a larger commitment to data integrity, product consistency, and regulatory compliance. Once a working standard is qualified,...
by Jeffrey Wotton | Apr 11, 2025 | Biopharma Consultant, Insights, Pharma Consulting, Working Reference Standard, Working standard qualification
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...
by Jeffrey Wotton | Apr 1, 2025 | Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Understanding the Difference Between Working Standards and Reference Standards in Biopharma In the biopharmaceutical industry, accurate and consistent analytical testing is essential to ensure product quality, safety, and regulatory compliance. One of the key...
by Jeffrey Wotton | Oct 23, 2023 | Case Study, Working Reference Standard, Working standard qualification
Creating Working Reference Standard (WRS) Qualification Protocols Approved and ready to use WRS qualification protocols significantly reduce workload, time and resources when transitioning from one WRS lot to another. Primary reference standards (PRS), secondary...
