Part of the Cleaning Validation for the 21st Century series
The convergence of regulatory agencies and acceptance of ICH Q12 across multiple agencies opens up opportunities for changes with minimal supply chain disruptions. The guidance facilitates management of post-approval CMC changes in a predictable and efficient manner.
I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.
A team composed of nearly 70 FDA, pharma/biotech, and medical device leaders — spanning 39 organizations and five countries — have concluded that companies trying to get a handle on issues in their supply chains should focus less on their suppliers and more on themselves as the possible source of the problems.
Diabetes remains one of the top causes of mortality, with approximately 4 million deaths in 2017.1 While recent advances in care have improved the quality of life for diabetics, much needs to be done to permanently cure the disease. Regenerative medicine could be a game-changing approach to meet the needs of insulin-dependent patients. Although the field is still in its infancy, the initial clinical data looks promising. Below we take a closer look at a few innovative companies that are racing to bring the first regenerative medicine for diabetes to the market.
Restricted-access barrier systems (RABS) have been a major part of pharmaceutical aseptic filling operations for many years. They were introduced around the year 2000, and by 2007 there were 75 installations in the business globally. Today, there may be several hundred, most of which are in GMP-compliant facilities and serving the needs of the business.
The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.
In the first article of this two-part series, we provided an overview of a co-creation model for change management and the tools and methodologies that form the foundation for improved change management. This second part will look at strategies for implementing an improved change management process.
The FDA recently posted the final guidance Data Integrity and Compliance with Drug CGMP Questions and Answers, finalizing a draft first published in April 2016. This article provides an overview and analysis of the guidance's 18 questions, which span the broad areas of data integrity and data governance.
Migraine is a highly prevalent disease, with more than 30 million “migraineurs” living in the United States alone. Migraine comprises two main populations: episodic migraine (EM; patients suffering less than 15 headache days per month) and chronic migraine (CM; patients suffering 15 or more headache days per month, with at least eight having migraneous features).
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