Lessons Learned from FDA Inspections of Foreign API Facilities
Certifying Excipient cGMPs
PAT Paves the Way for Continuous Manufacturing
Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry
The PharmTech/CPhI Connection
Utilizing Run Rules for Effective Monitoring in Manufacturing
Pharmaceutical Technology, September 2015 APIs, Excipients, and Manufacturing Supplement (PDF)
Cleaning of Dedicated Equipment: Why Validation is Needed
Excipient Selection for Protein Stabilization
Import Testing of Pharmaceutical Products Has Limited Safety Benefits and Can Add Risk to Patients