Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
|Articles|January 2, 2004
- Pharmaceutical Technology-01-02-2004
- Volume 28
- Issue 1
Medicare Bill Contains Significant Changes for Drug Manufacturers
Author(s)Jill Wechsler
The new Medicare bill affects pricing and coverage, revises payment formula, and clarifies generic patent issues.
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Articles in this issue
almost 23 years ago
Coprocessed Excipients for Solid Dosage Formsalmost 23 years ago
Manufacturing Execution Systemsalmost 23 years ago
State-of-the-Art Packaging Machinesalmost 23 years ago
January 2004almost 23 years ago
The Bioterrorism Actalmost 23 years ago
New Supply-Chain Dynamicsalmost 23 years ago
In the Spotlight--February 2004almost 23 years ago
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Related to this article
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and how GMP limits and GxP validation shape adoption.
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
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