Manufacturing· September 18, 2026 · 31 min read
A Supplier COA Is Not Component Identity Testing
By Ran Chen#API Manufacturing#CDMO#CMC
Topic
CMC
Chemistry, manufacturing, and controls, including regulatory submissions, post-approval changes, established conditions, and global lifecycle management.
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 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
Manufacturing· September 6, 2026 · 30 min read
Annex 1 CCS Is Not FDA's 2026 Packaging CCS, and Neither Replaces 2004 Aseptic Guidance
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Manufacturing· August 25, 2026 · 15 min read
FDA's 2026 CCS Draft Replaces 1999 Packaging Guidance, Not Biosimilar Devices
By Ran Chen#CMC#Manufacturing#Combination Product
Manufacturing· August 24, 2026 · 17 min read
FDA's ACTIMP Potency Guidance: Personalized Peptide and Neoantigen Lot Release
By Ran Chen#CMC#Manufacturing Capacity#Pipeline