Manufacturing· September 17, 2026 · 27 min read
Equipment Qualification Is Not Process Performance Qualification
By Ran Chen#CMC#Manufacturing#Manufacturing Capacity
Topic
Regulatory
Regulatory strategy, FDA and EMA submissions, postmarketing requirements, accelerated approval obligations, and lifecycle compliance.
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
Policy· September 7, 2026 · 34 min read
EClinCloud AI-Assisted Study Build: What Sponsors Must Accept Before EDC Go-Live
By Ran Chen#FDA#Regulatory#Clinical Trials
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
Policy· August 25, 2026 · 15 min read
Wound PFDD Does Not Reset Skin-Substitute Pay; 351 BLAs Would Face Rebates
By Ran Chen#Medicare Part B#CMS#Drug Pricing