Darshan Singh

Darshan Singh

Author is a pharmaceutical quality and regulatory professional with more than 23 years in drug manufacturing. He holds an M.Sc. in Organic Chemistry and a Diploma in Pharmacy. He has served as Quality Control Head, Quality Assurance Head and Plant Head, overseeing all manufacturing operations. He is co-founder and regulatory consultant at Laafon Galaxy Pharmaceuticals. He writes on SOPs, manufacturing processes, Schedule M compliance and drug pharmacology, and checks each claim against pharmacopoeial and regulatory sources.
  • Joined: July 17, 2024
  • Articles: 242

USFDA Inspection Checklist: 6 Systems FDA Audits (2026)

USFDA inspection checklist: six-system CGMP inspection model

Short answer A USFDA inspection checklist for a pharmaceutical facility should follow the six systems FDA investigators audit under CGMP: quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. A drug manufacturing inspection normally covers at least…

FDA Novel Drug Approvals 2025: All 46 Drugs & Designations

FDA novel drug approvals 2025 list

In 2025, the FDA approved 46 novel drugs, a decrease from 50 in 2024. Of these, 20 were first-in-class and 23 had orphan designations. The approvals included 16 oncology drugs and utilized various expedited programs. Most drugs were approved in the U.S. before other countries, reflecting a stable trend in novel approvals.