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.
News|Articles|October 2, 2004
- Pharmaceutical Technology-10-02-2004
- Volume 28
- Issue 10
Visible-Residue Limit for Cleaning Validation and its Potential Application in Pharmaceutical Research Facility
Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.
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Articles in this issue
almost 22 years ago
A Novel Freeze Pelletization Technique for Preparing Matix Pelletsalmost 22 years ago
Aseptic Processing: A Review of Current Industry Practicealmost 22 years ago
Can Inserts Be Improved?almost 22 years ago
Drug Development Linked More Closely to Diagnosticsalmost 22 years ago
In The Spotlight-October 2004almost 22 years ago
October 2004almost 22 years ago
The High Price of Successalmost 22 years ago
Pharma Company Investment in Parenteral Manufacturing Capacity Picking UpAdvertisement
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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.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
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