Regulatory + Quality Assurance | Michelle Lott | lean RAQA

Biologics

Procedures. Procedures. Procedures.

Want a 483 or warning letter of your very own? Easy! Ignore a procedure. Failing to follow Current Good Tissue Practices (cGTPs) is a good one to get your feet wet. You’ll have plenty of company. It was the most common transgression last year.

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21 CFR 1271.265(f)

Return to inventory – procedures

21 CFR 1271.47(a)

Donor eligibility procedures

21 CFR 1271.47(a)

Procedures for all steps

21 CFR 1271.320(a)

Procedures re complaints

21 CFR 1271.265(e)

Procedures and release criteria

21 CFR 1271.75(e)

Abbreviated procedure

21 CFR 1271.230(a)

Process validation procedures

21 CFR 1271.190(d)(1)

Procedures for cleaning, sanitation

21 CFR 1271.200(c)

Calibration procedures and schedules (general)

21 CFR 1271.230(a)

Validation & approval – established procedures

Shall I Continue?

No, you get the idea. We hate to see bad things happen to companies doing good, important work. In my storied (indulge me) career, I’ve seen one too many “If only so-and-so followed the procedure, we could have avoided this” messes that cratered otherwise-promising technologies.

Contact us so you can avoid the same fate. Please?

call me

I think people would prefer to put time on the calendar rather than call. I suggest changing to “Let’s connect”

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Let’s test your knowledge of biologic hot buttons. There’s no shame in not knowing all the answers. Incidentally, FDA and other regulators don’t care if you “just didn’t know it.”

It’s your JOB to have someone who knows it – really well – on your team. For smaller companies, you may not have enough regulatory and quality work to justify headcount.

  • 1. What is the difference in quality system requirements between 351 vs a 361 product?
  • 2. Regarding the Code of Federal Regulations (CFR), how do I know if I need to apply 21 CFR 820 or 21 CFR 211 in addition to my existing quality system requirement?
  • 3. How do I determine if my product for homologous use?
  • 4. How do I determine if my product is minimally manipulated?
  • 5. How do I know if my biological product requires an FDA submission?
  • 6. What type of FDA submission does my biologic product require?
  • 7. How do I know which cCGTP elements apply to my quality system?
  • 8. Is there a way around cGTP so I don’t have to comply with it?
  • 9. How do I determine what donor testing I need to perform?
  • 10. How do I know which events require deviation reporting?

So How’d You Do?

🌟 10: You’re a superstar.

What are you doing here? You’ve totally got this.

💪 9: Impressive!

How can I complement what you’re already doing?

😬 8 or fewer…

To be safe, put time on my calendar. “Too proud to ask Michelle” is no reason for a 483 or warning letter. Plus I like meeting new people!

Help Has Arrived!

Pick an open half hour on my calendar. Maybe I can lighten your workload and I would LOVE to help!

let’s connect!