Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.
Let's take a moment to go into detail of one of the most widely used distribution simulation test methods, ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems.
Method Validation effects the development and quality control testing of most products. Updated FDA guidance titled Analytical Procedures and Methods Validation for Drugs and Biologics
With the increasing utilization of ultracold frozen storage to maintain product potency, the question arises: how do we verify container closure integrity at these extremely low temperatures?
A few months back I published a blog article on the value of attending Interphex. For the regular readers (I know there are few), you will recall that I started that article by simply stating my dista
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. The presence of residual solvents in pharmaceutical products needs to be determined through testing
As development of biologics and biosimilars forges on, the autoinjector remains on the rise. Industry shifts to deterministic test methods translate to a need to develop and validate methods for autoinjectors
Three years ago, the executive management of Whitehouse Laboratories implemented a major reorganization plan. Over the previous ten years, the company had experienced many areas of growth to include e
CCIT programs in lifecycle of a product-package system; from development of the package, to stability, to analysis of package integrity after distribution cycles. As related to proposed revisions to USP 1207
In the past four or so years working with clients to develop and validate container closure integrity (CCI) test methods, there have been a number overarching trends that have become readily apparent.