Quick answer · last reviewed 1 November 2026 Grafapex cost at its US list price is US$610 per 1 g vial and US$3,050 per 5 g vial — the same US$610 per gram either way.[3] A full course of 10…
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…
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.
Updated 22 Oct 2026 · Reviewed by Darshan Singh, 23+ years in pharmaceutical QA, QC and regulatory affairs Short answer Aseptic processing control is the set of facility, airflow, monitoring, sterilisation and behavioural controls that keeps a sterile product free…
GMP · Export regulation · India Reviewed by Darshan Singh, 23+ years in pharma QA, QC and regulatory affairs · Updated 21 Oct 2026 WHO-GMP vs USFDA cGMP: the short answer WHO-GMP vs USFDA is not a choice between two…
Short answer What a PAI inspection readiness checklist must cover in 2026 A PAI inspection readiness checklist has to be built around FDA’s four preapproval inspection objectives in Compliance Program 7346.832, revised on 29 June 2026 and implemented from 10…
Short answer ICH Q9 quality risk management now shapes a USFDA inspection twice. First, CDER decides which drug sites to inspect with a risk-based Site Selection Model, as FD&C Act section 510(h) requires.[1] Then, on site, investigators judge whether your…
Short answer · reviewed 19 Oct 2026 A USFDA warning letter is FDA’s public notice that it found significant violations at your facility. You are normally asked to reply in writing within 15 working days, by email to the address…
By Darshan Singh, former QC Head, QA Head and Plant Head (23+ years) Updated 17 Oct 2026 Rule text checked against eCFR, current to 14 Oct 2026 Short answer What 21 CFR Part 11 actually requires 21 CFR Part 11…
Short answer · reviewed 16 Oct 2026 How to respond to a USFDA Form 483 A Form FDA 483 lists the conditions an FDA investigator thinks may violate the FD&C Act. It is handed over at the end of the…