by Jeffrey Wotton | May 30, 2025 | Biopharma Consultant, Biotech Consulting, Insights, Pharma Consulting, Quality assurance compliance consulting, Working Reference Standard, Working standard qualification
Stability Testing Strategies for Working Standards In the biopharmaceutical industry, maintaining the integrity and reliability of analytical results is paramount. One crucial element in achieving this is ensuring the stability of working reference standards (WRS)....
by Jeffrey Wotton | May 30, 2025 | Biopharma Consultant, Biotech Consulting, GMP Good Manufacturing Practices, Insights, Pharma Consulting, Quality assurance compliance consulting
How to Prepare for a GMP Inspection: A Consultant’s Perspective Good Manufacturing Practice (GMP) inspections are pivotal events for pharmaceutical and biotech companies. A successful inspection can affirm your organization’s commitment to quality and regulatory...
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 25, 2025 | Biopharma Consultant, Biotech Consulting, Pharma Consulting
The Importance of Vendor Qualification in GMP Environments In biopharmaceutical manufacturing, quality is only as strong as the weakest link in your supply chain. From raw materials and equipment to testing labs and logistics providers, third-party vendors play a...
by Jeffrey Wotton | Apr 18, 2025 | Biopharma Consultant, Insights
Bridging the Gap Between R&D and Commercialization in Biopharma In the high-stakes world of biopharmaceutical development, the path from laboratory research to commercial product is rarely linear. Complex regulatory landscapes, evolving quality requirements, and...
