Regulatory Open Forum

Hi everyone,

I am trying to look for a guidance document, from FDA or any other regulatory body, on scale validation during clinical studies. I am having a hard time finding anything online. 

I'd really appreciate if someone can help me out with this. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------

I've never seen a specific guidance document from the FDA on scale validation.  But it's been my experience (30 years) that you build 3 validation lots of increasing size.  The sizes can be small, medium, and the third one is based on the company's planned final production size.  Then perform the clinical trial precision study with all three lots.

Hope this helps.

Judith Smith
Vice President, In Vitro Diagnostics and Quality
Precision For Medicine
Bethesda MD
United States
-------------------------------------------


Original Message:
Sent: 06-27-2014 10:20
From: Alay Bhayani
Subject: Scale Validation Guidance Documents

Hi everyone,

I am trying to look for a guidance document, from FDA or any other regulatory body, on scale validation during clinical studies. I am having a hard time finding anything online. 

I'd really appreciate if someone can help me out with this. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------

It is unlikely that you will find anything because scales are not usually validated. Instead, they are calibrated. All of the inspection, measuring, and test equipment used in your study should be in current calibration. You will need a calibration lab. Look for one that has an ISO/IEC 17025 certification and, for the US, can provide traceability to NIST.

-------------------------------------------
Dan O'Leary
Ombu Enterprises, LLC
Swanzey NH
United States
-------------------------------------------


Original Message:
Sent: 06-28-2014 11:10
From: Judith Smith
Subject: Scale Validation Guidance Documents

I've never seen a specific guidance document from the FDA on scale validation.  But it's been my experience (30 years) that you build 3 validation lots of increasing size.  The sizes can be small, medium, and the third one is based on the company's planned final production size.  Then perform the clinical trial precision study with all three lots.

Hope this helps.

Judith Smith
Vice President, In Vitro Diagnostics and Quality
Precision For Medicine
Bethesda MD
United States
-------------------------------------------


Original Message:
Sent: 06-27-2014 10:20
From: Alay Bhayani
Subject: Scale Validation Guidance Documents

Hi everyone,

I am trying to look for a guidance document, from FDA or any other regulatory body, on scale validation during clinical studies. I am having a hard time finding anything online. 

I'd really appreciate if someone can help me out with this. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------

I might add to Dan's excellent post.  When calibrating measurement equipment used in Design Verification or Design Validation activities, a common practice is to check calibration before and after the activity to insure the equipment continued to be in calibration through the measurement activity performed.  This might be a good practice for your clinical studies as well.

-------------------------------------------
Edwin Bills RAC
Principal Consultant
ELB Consulting
Butler KY
United States
-------------------------------------------


Original Message:
Sent: 06-28-2014 11:40
From: Dan O'Leary
Subject: Scale Validation Guidance Documents

It is unlikely that you will find anything because scales are not usually validated. Instead, they are calibrated. All of the inspection, measuring, and test equipment used in your study should be in current calibration. You will need a calibration lab. Look for one that has an ISO/IEC 17025 certification and, for the US, can provide traceability to NIST.

-------------------------------------------
Dan O'Leary
Ombu Enterprises, LLC
Swanzey NH
United States
-------------------------------------------


Original Message:
Sent: 06-28-2014 11:10
From: Judith Smith
Subject: Scale Validation Guidance Documents

I've never seen a specific guidance document from the FDA on scale validation.  But it's been my experience (30 years) that you build 3 validation lots of increasing size.  The sizes can be small, medium, and the third one is based on the company's planned final production size.  Then perform the clinical trial precision study with all three lots.

Hope this helps.

Judith Smith
Vice President, In Vitro Diagnostics and Quality
Precision For Medicine
Bethesda MD
United States
-------------------------------------------


Original Message:
Sent: 06-27-2014 10:20
From: Alay Bhayani
Subject: Scale Validation Guidance Documents

Hi everyone,

I am trying to look for a guidance document, from FDA or any other regulatory body, on scale validation during clinical studies. I am having a hard time finding anything online. 

I'd really appreciate if someone can help me out with this. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------

Alay,

What do you mean "scale validation" during clinical studies?

• Process scale (e.g., batch scale)?
• Scale (e.g., balance)?
• Grading scale or rating scale?
• PRO?

It sounds like you may be referring to process scale validation?

In any case, I have a guidance(s) that I can refer to.

Waiting for your clarification.

Thank you.  

-------------------------------------------

http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------


Original Message:
Sent: 06-27-2014 10:20
From: Alay Bhayani
Subject: Scale Validation Guidance Documents

Hi everyone,

I am trying to look for a guidance document, from FDA or any other regulatory body, on scale validation during clinical studies. I am having a hard time finding anything online. 

I'd really appreciate if someone can help me out with this. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------

Hi everyone,

Thanks for your response. I apologize it wasn't clear as to what "scale" I was referring to in my original post. I was referring to a grading or rating scale. 

Let me know if there is any guidance in that area. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------


Original Message:
Sent: 06-27-2014 10:20
From: Alay Bhayani
Subject: Scale Validation Guidance Documents

Hi everyone,

I am trying to look for a guidance document, from FDA or any other regulatory body, on scale validation during clinical studies. I am having a hard time finding anything online. 

I'd really appreciate if someone can help me out with this. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------

Alay,

Thank you.  

As for grading scale, there are few FDA guidances for your consideration.  

http://www.fdaguidance.net/2014/06/toxicity-grading-scale-for-healthy-adult-and-adolescent-volunteers/
http://www.fdaguidance.net/2014/06/e9-statistical-principles-for-clinical-trials/
Patient reported outcome measures
-------------------------------------------
http://www.regulatorydoctor.com
Riner VA
United States
-------------------------------------------


Original Message:
Sent: 06-30-2014 10:47
From: Alay Bhayani
Subject: Scale Validation Guidance Documents

Hi everyone,

Thanks for your response. I apologize it wasn't clear as to what "scale" I was referring to in my original post. I was referring to a grading or rating scale. 

Let me know if there is any guidance in that area. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------


Original Message:
Sent: 06-27-2014 10:20
From: Alay Bhayani
Subject: Scale Validation Guidance Documents

Hi everyone,

I am trying to look for a guidance document, from FDA or any other regulatory body, on scale validation during clinical studies. I am having a hard time finding anything online. 

I'd really appreciate if someone can help me out with this. 

Thanks,
Alay

-------------------------------------------
Alay Bhayani
Regulatory Affairs Manager
Allergan
Goleta, CA
United States
-------------------------------------------