Articles by Martin van Trieste - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

  • Search
  • Suppliers
  • Careers

Enter a company or product name

Keyword Location
About Search
Articles by Martin van Trieste

Biosimilars Development and Supply: How Complex Can the Process Be?

As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Sep 2, 2013

As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.

Achieving More Effective and Efficient GMP Auditing

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products. Due to the limitations of quality-control testing and repeatedly occurring major API adulterations, the regulations for supplier qualification have been globally tightened. As a consequence, authorities demand more vigilance of the pharmaceutical supply chain. API and other starting material manufacturers are facing an ever-increasing demand for on-site audits from their pharmaceutical customers.
Feb 1, 2013

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
FindPharma Custom Search
Click here