by Jeffrey Wotton | Aug 29, 2025 | Biopharma Consultant, Biotech Consulting, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Primary Reference Standard, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
The Critical Role of Gap Assessment in Reference Standard Qualification Programs In the biopharmaceutical industry, the establishment of Primary Reference Standards (PRS) and Working Reference Standards (WRS) is a cornerstone of quality control, regulatory compliance,...
by Jeffrey Wotton | Aug 29, 2025 | Biopharma Consultant, Biotech Consulting, Case Study, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Primary Reference Standard, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Implementation of Primary Reference Standard and Working Reference Standard Procedures in a Biopharmaceutical Company A case study from BioPharma Consulting Group Background Biopharmaceutical Company A, a mid-sized company specializing in monoclonal antibody...
