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This Month On IVT Network
Writing Validation Requests and Validation Plans
Paul Pluta, Ph.D., explains the process of connecting Stage 1 and Stage 2 of process validation through properly written and well formed validation requests and validation plans. Read More
LATEST JVT JOURNAL ARTICLES
Method Suitability Control Studies for Microbial Testing: Quantitative Comparisons
The measurement of microbial kill requires the ability to measure the number of surviving microorganisms with time after exposure to the antimicrobial agent.
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Bacterial Adhesion: an Introduction
The phenomenon of bacterial adhesion is an important phenomenon for those working within the pharmaceutical and healthcare sectors to consider. Read More
FDA Plans to Tighten Regulations Concerning Defibrillators
The U.S. Food and Drug Administration today [March 22, 2013] issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). Read More
Degradation of Pharmaceutical Solids Accelerated by Changes in Both Relative Humidity and Temperature and Combined Storage Temperature and Storage Relative Humidity (T×h) Design Space for Solid Products
As noted in a previous report, achieving quality by design (QbD), rather than by testing to demonstrate compliance with specifications, is a concept in quality assurance that evolved in the last decade of the twentieth century.Read More
LATEST GXP JOURNAL ARTICLES
Analysis of Recent Drug GMP Inspections by FDA and AIFA: Different Approaches and Significant Trends
Companies regulated under good manufacturing practices (GMPs) are routinely inspected by health authorities in order to ensure the quality, safety, and efficacy of their products. Read More
Implementing an Effective Provider Qualification Program at the Contract Laboratory
This paper is intended to provide useful hands-on guidance regarding the process of provider qualification. Read More
Ownership Responsibilities for the Pharmaceutical Quality Management System: Setting New Expectations
The pharmaceutical quality management system (QMS) is comprised of policies, standards, procedures, and other approved instructions that declare how a firm intends to apply company requirements, laws, and regulations to their operations. Read More
Mitigating Risk Associated with Multitasking
Multitasking has taken on broad definitions, including doing more than one task at the same time, dealing with shifting priorities, managing multiple projects, doing more work than time permits, and many other situations. Read More
   
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