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.
|Articles|November 15, 2016
- Pharmaceutical Technology-11-15-2016
- Volume 2016 eBook
- Issue 3
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?
Author(s)Agnes Shanley
Could greater market transparency improve pharmaceutical quality and regulatory compliance?
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A new website and methodology would rank manufacturers based on quality and good manufacturing and business practices. Martin Van Trieste discusses the principles behind medicine-i.com, which he has started up, using software designed by Richard Love, CEO of HarborView.
The site will be driven by algorithms that take quality, compliance and shortages data and rank suppliers based on their level of control in each area.
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Articles in this issue
almost 10 years ago
Extending QMS to Contract Partnersalmost 10 years ago
Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilizationalmost 10 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Is Global Regulatory Gridlock Slowing Modernization?almost 10 years ago
Paperless Batch Records for the Massesalmost 10 years ago
Ensuring Quality in Pharmaceutical Raw Materialsalmost 10 years ago
Microbiological Testing: Time is of the EssenceAdvertisement
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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.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
Karthik Iyer, Eli Lilly, detailed an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
AI can turn medical device risk management into a continuous signal.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
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