FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
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
about 22 years ago
A Novel Freeze Pelletization Technique for Preparing Matix Pelletsabout 22 years ago
Aseptic Processing: A Review of Current Industry Practiceabout 22 years ago
Can Inserts Be Improved?about 22 years ago
Drug Development Linked More Closely to Diagnosticsabout 22 years ago
In The Spotlight-October 2004about 22 years ago
October 2004about 22 years ago
The High Price of SuccessAdvertisement
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Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
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