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.
News|Articles|April 2, 2005
- Pharmaceutical Technology-04-02-2005
- Volume 29
- Issue 4
Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility
An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.
Advertisement
Articles in this issue
over 21 years ago
April 2005over 21 years ago
Management Controls for GMP Complianceover 21 years ago
PAT and Process Understanding: A Call to Armsover 21 years ago
Cold Chain Concernsover 21 years ago
Evolutions in Direct Compressionover 21 years ago
X-ray Microtomography of Solid Dosage Formsover 21 years ago
Orient ExpressAdvertisement
Related to this article
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.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
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.
This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.
Advertisement
Advertisement