Manufacturing· October 10, 2026 · 14 min read
Returned Drug Lots: When to Reprocess or Destroy Under CGMP
By Ran Chen
Section
Manufacturing
Capacity, CDMO strategy, inspections, supply bottlenecks, and manufacturing constraints that shape commercial reality.
45 articles · Last updated
Manufacturing· October 9, 2026 · 13 min read
A Missed Stability Pull: Documenting Impact and the Follow-Up Plan
By Ran Chen
Manufacturing· October 6, 2026 · 31 min read
Drug Substance vs Drug Product CDMOs: Dividing the Scope of Work
By Ran Chen
Manufacturing· October 5, 2026 · 24 min read
Reference vs Retention Samples: Planning Storage and Future Testing
By Ran Chen
Manufacturing· October 3, 2026 · 23 min read
Drug Shortage Notifications: Interruption vs Permanent Discontinuation
By Ran Chen
Manufacturing· September 28, 2026 · 32 min read
Nitrosamine Risk Reviews: What to Request From an API Supplier
By Ran Chen
Manufacturing· September 18, 2026 · 31 min read
A Supplier COA Is Not Component Identity Testing
By Ran Chen#API Manufacturing#CDMO#CMC
Manufacturing· September 17, 2026 · 27 min read
Equipment Qualification Is Not Process Performance Qualification
By Ran Chen#CMC#Manufacturing#Manufacturing Capacity
Manufacturing· September 16, 2026 · 31 min read
A Master Batch Record Is Not an Executed Batch Record
Manufacturing· September 15, 2026 · 29 min read
An Annual Product Review Is Not Continued Process Verification
By Ran Chen#CMC#Manufacturing#FDA