Manufacturing· September 18, 2026 · 31 min read
A Supplier COA Is Not Component Identity Testing
By Ran Chen#API Manufacturing#CDMO#CMC
Topic
CDMO
Contract development and manufacturing organizations, CDMO oversight, quality agreements, manufacturing site changes, and supply chain strategy.
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
Manufacturing· September 14, 2026 · 29 min read
An OOS Result Is Not Confirmed Failure or a Field Alert
By Ran Chen#CMC#FDA#Manufacturing
Manufacturing· September 13, 2026 · 26 min read
A PPQ Protocol Is Not Commercial Batch Release: Stage 2 Versus Stage 3 Records
By Ran Chen#CMC#Manufacturing Capacity#Manufacturing
Manufacturing· September 8, 2026 · 23 min read
Starter-PN Compounding Discretion Is Not an Approved Drug or 503B CGMP Waiver
Manufacturing· September 7, 2026 · 28 min read
PreCheck's Type V Facility DMF Is Not a PAI, and a CDMO Seat Does Not Transfer CGMP
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Policy· July 21, 2026 · 17 min read
FDA Class I Medical Device Recalls by the Numbers (2026)
Manufacturing· July 21, 2026 · 18 min read
Orthopedic & Spinal Implant GUDID UDI Landscape (2026)
By Ran Chen#Supply Chain#CDMO#BIOSECURE Act