New Guidelines for Compliance Audits

The latest update from the FDA emphasizes stricter adherence to good manufacturing practices for biotech companies. This change seems crucial, especially with the increasing scrutiny in our sector. I’m curious to hear how others are preparing for these audits. Are there specific areas you’re focusing on to ensure compliance?

‌⁠‍⁠​‍​‍‌⁠‌​​‍​‍​⁠‍‍​‍​‍‌‍‌⁠‌‍​‍‌⁠‌​‌‍‍‍​‍​‍​‍⁠​​‍​‍‌‍‍⁠​‍​‍​⁠‍‍​‍​‍‌‍⁠‍‌‍‌‌‌⁠‌⁠‌‌⁠⁠‌⁠‌​‌‍⁠⁠‌⁠​​‌‍‍‌‌‍​⁠​‍​‍​‍⁠​​‍​‍‌‍‍‌‌‍‌​​‍​‍​⁠‍‍​‍​‍‌‍⁠‍‌‍‌‌‌⁠‌⁠​‍​‍​‍⁠​​‍​‍‌‍‌​​‍​‍​⁠‍‍​‍​‍​⁠​‍​⁠​​​⁠​‍​⁠‌‍​⁠​​​⁠‌‍​⁠​‌​⁠‍‌​‍​‍​‍⁠​​‍​‍‌‍‍​​‍​‍​⁠‍‍​‍​‍‌‌​‌‌‌⁠⁠‌⁠‌‍‌​‍​​⁠‍​‌‌‍‍‌‌‌‌‌‌‌​‌⁠‌⁠‌‍​⁠‌‍‌‍‌⁠​‍‌⁠​​​⁠‍‌‌‍⁠⁠‌‌‌‌​‍​‍‌⁠⁠‌​

But i think it’s a good idea to tighten up our SOPs; it’s like checking your seatbelt before a road trip. Are you all looking at training sessions to keep the team up to speed on these changes?

‌⁠‍⁠​‍​‍‌⁠‌​​‍​‍​⁠‍‍​‍​‍‌‍‌⁠‌‍​‍‌⁠‌​‌‍‍‍​‍​‍​‍⁠​​‍​‍‌‍‍⁠​‍​‍​⁠‍‍​‍​‍‌⁠​‍‌‍‌‌‌⁠​​‌‍⁠​‌⁠‍‌​‍​‍​‍⁠​​‍​‍‌‍‍‌‌‍‌​​‍​‍​⁠‍‍​⁠‌‍​⁠‌‌​⁠​⁠​‍⁠​​‍​‍‌‍‌​​‍​‍​⁠‍‍​‍​‍​⁠​‍​⁠​​​⁠​‍​⁠‌‍​⁠​​​⁠‌‍​⁠​‍​⁠​‌​‍​‍​‍⁠​​‍​‍‌‍‍​​‍​‍​⁠‍‍​‍​‍‌⁠​‍​⁠‌‌​⁠‍​‌⁠‌⁠‌‍‌‍‌‍⁠‌‌‌‍​‌‌‍‍‌​‍‍‌⁠​​‌⁠​‍‌‍‍‌‌‍‍⁠‌​‍‌‌‍⁠‍‌‌​⁠​‍​‍‌⁠⁠‌​