Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
News|Articles|November 2, 2004
- Pharmaceutical Technology-11-02-2004
- Volume 28
- Issue 11
Method Validation by Phase of Development: An Acceptable Analytical Practice
This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.
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Articles in this issue
almost 22 years ago
Still Waiting for Answersalmost 22 years ago
Comparing and Contrasting Barrier Isolator Decontamination Systemsalmost 22 years ago
November 2004almost 22 years ago
In the Spotlight-November 2004almost 22 years ago
Searching for a Viable Business Modelalmost 22 years ago
FDA Moves To Implement New GMP PoliciesAdvertisement
Related to this article
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
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