Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
|Articles|June 2, 2001
- Pharmaceutical Technology-06-02-2001
- Volume 25
- Issue 6
Managing Risks and Resources
Author(s)Jill Wechsler
FDA's new initiatives for the safe use of prescription drugs try to balance manufacturers' concerns about increased regulations with a low-risk approach to patient safety.
Advertisement
Articles in this issue
over 25 years ago
Viral Clearance Strategies for Biopharmaceutical Safetyover 25 years ago
Outsourcing Outlookover 25 years ago
Blister News: COC Resin, Foil, and Lidding Innovationsover 25 years ago
Managing the Risks in Outsourcingover 25 years ago
Systemic Drug Delivery via the Buccal Mucosal RouteAdvertisement
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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.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.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Why AI Model Updates Need Change Control: AAPS PharmSci 360 2026
2
From URS to Acceptance Evidence: Defining and Testing Interfaces in Pen Injector Assembly
3
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
4
AAPS PharmSci 360 2026: IND-Enabling Studies vs Animal Data
5