Articles by James P. Agalloco - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe
  • Search
  • Suppliers
  • Careers

Enter a company or product name

Keyword Location
About Search
Articles by James P. Agalloco
« Previous
123

Managing Aseptic Interventions

Mar 2, 2005
By: James P. Agalloco

This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.

Aseptic Processing: A Review of Current Industry Practice

Oct 2, 2004
By: James P. Agalloco

The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.

Perspectives on Aseptic GuidanceA Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

May 1, 2004
By: James P. Agalloco

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

« Previous
123

ADVERTISEMENT
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
20%
To all process for new products only
13%
To select process for new products only
24%
To select processes for both new and legacy products
20%
Do not use QbD
22%
View Results
Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
FindPharma Custom Search
Featured Jobs

More Jobs
Click here