Operations and Quality Oversight of CMOs
Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.
CMO partnerships can be challenging both for the CMO and the product owner. The article maps out optimal organizational designs for CMOs and product owners that increase the likelihood of a successful partnership and ensure consistent, reliable, and quality supply of drug product.
Download BioPharm International's
2017 Outsourcing Resources eBook.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck
May 28th 2025Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.
