justin@cruxstudios.ca

Formula Won or Formula None?

What can Formula One teach us about pharmaceutical quality? A lot more than you might think. From Red Bull’s recent struggles to the design of your QMS, this post explores how performance, alignment, and teamwork aren’t just race-day essentials — they’re critical to compliance and operational success in pharma. Read the full post to see why a system only one person can drive might not be a system at all.
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ICH Issues Updated Draft of its Q1 Guideline on Stability Testing

After more than two decades, ICH has released a major update to its Q1 guideline on stability testing, combining Q1A–F and Q5C into a modernized, comprehensive document. With expanded guidance on ATMPs, novel excipients, modeling, and in-use studies, this draft is a must-watch for Regulatory Affairs professionals. Explore what’s changing and why it matters for your next submission.
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Heather Smith

Herrington Editor Post Blog

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