Welcome to the StabilityHub search portal! Dive into a wealth of knowledge about medical product stability using our intuitive and powerful search. From stability publications and regulatory guidelines to the latest blog posts, our search functionality looks across our entire site to bring you information you need.
Not sure what you’re looking for? Browse the Hubrary Classification System across all of StabilityHub’s data!
Post
Introduction In recent years, the Brazilian human health regulatory authority ANVISA, has issued a number of documents describing in detail what is expected to be presented in a Regulatory submission in Brazil for Forced [...]
Post
Introduction ANVISA, the Brazilian human health regulatory authority, has issued in the recent years a number of documents describing in detail what is expected to be presented on Forced Degradation Studies and how they [...]
Post
This blog post is Part 2 of the series and comes to us from Piero De Filippis, StabilityHub EU Regional Contributor, Verona (Italy). Introduction This blog reports key points to consider when assigning or [...]
Post
This blog post is Part 1 of the series and comes to us from Piero De Filippis, StabilityHub EU Regional Contributor, Verona (Italy). Part 1: Stability Study Design for an Investigational Medicinal Product European [...]
Post
Japan is planning to change some of its quality-related regulations. First is post-approval change management, a process already started on March 9, 2018. This is a system raised through ICH Q12 discussion that if [...]
Post
In the tightly regulated world of pharmaceutical, medical device, and biologics manufacturing, contract storage facilities – warehouses or off-site stability storage facilities - play a vital role in ensuring product integrity over time. Whether [...]
Post
Hollister Incorporated, a global, employee-owned healthcare manufacturer, began a critical modernization initiative to overhaul its stability program. For years, Hollister had relied on traditional, paper-based systems to manage complex stability studies supporting the development [...]
Post
One of the most intelligent moves I’ve seen a corporate Stability organization make was the establishment of a Stability Intelligence (SI) Specialist within its ranks. Someone whose primary responsibility was to continuously monitor the [...]
Event
Including an overview of ICH Guideline for Extractables and Leachables (Q3E), Step 2 Guideline--Don't miss your opportunity for public comment! This two-day conference will examine the safety, quality, and regulatory issues involved in a wide [...]
Post
Disasters occur whether we plan for them or not, but planning ahead to mitigate their impact and recover from their damage can make a big difference in corporate success. While we can’t control the nature [...]
Find Resources
Get Involved
Didn’t find what you were looking for? Search again!
Share your questions and experiences
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
