PDA Task Force Issues Guidelines to Aid Isolator Users

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-02-2002
Volume 26
Issue 3

When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.

External Link - article-12150.pdf

Articles in this issue
Outsourcing Outlook
Developing Custom Adhesive Systems for Transdermal Drug Delivery
Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part II
PDA Task Force Issues Guidelines to Aid Isolator Users
Recent Advances in Semisolid Dosage Forms for Dermatological Application
Drug Safety Concerns Shape Manufacturing Policy
Production Information Mangement
Functionality Testing of a Multifunctional Directly Compressible Adjuvant Containing Lactose, Polyvinylpyrrolidone, and Croscarmellose Sodium
Public CROs Craft New Strategies to Achieve Financial and Strategic Objectives
Validation Changes to the USP Assay Method for Ibuprofen Tablets
Systematic Troubleshooting for LC/MS/MS
Product Development Issues of Powders for Injection
Oral Low Molecular Weight Heparin Absorption From Solution and Solid Dosage Forms in Rat, Dog, and Monkey Models
Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method Transfer
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