Regulatory Open Forum

Hello everyone,

we have been seeing a separate 'GLP fee' line item on recent sterilization validation and automatic cleaning validation quotes from external test laboratories. We understand that all these facilities perform the studies under GMP but are pushing GLP as a 'value add.'
Is this truly a requirement from regulatory authorities? I ask this because the GLP fee is not insignificant compared to the total cost.
GLP is touted to include QA master file tracking of samples, QA audit of test phase and final report. It should be noted that we, as manufacturer, also take on most of these tasks as part of our internal practice; however, we are not the subject matter experts when it comes to sterilization and automatic cleaning validation.

Any and all guidance will be much appreciated.

Cheers
Thas

------------------------------
Thas Yuwaraj
------------------------------

Hi Thas,
If these procedures are going to be used on a GLP study, then yes, but the whole validation should be according to GLPs, not just certain aspects. If not, and if GMP is what you need, you do not need GLP aspects. Are their data not robust/reliable enough that they can't trust it on its own, and they need to offer "GLP" to make it more acceptable? I do not understand that.

GLP is just for nonclinical studies. I also should warn folks that it is not easy for a lab to be both GLP and GMP. The QA has totally different roles (In GLP, QA does not "accept" or "approve" anything, for example). One cannot have a true GLP study without the GLP structure, including a protocol, Study Director, etc.

I hope that helps!

Robin


------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
robinguy@robinguy.com
------------------------------

Original Message:
Sent: 13-Apr-2017 14:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Hello everyone,

we have been seeing a separate 'GLP fee' line item on recent sterilization validation and automatic cleaning validation quotes from external test laboratories. We understand that all these facilities perform the studies under GMP but are pushing GLP as a 'value add.'
Is this truly a requirement from regulatory authorities? I ask this because the GLP fee is not insignificant compared to the total cost.
GLP is touted to include QA master file tracking of samples, QA audit of test phase and final report. It should be noted that we, as manufacturer, also take on most of these tasks as part of our internal practice; however, we are not the subject matter experts when it comes to sterilization and automatic cleaning validation.

Any and all guidance will be much appreciated.

Cheers
Thas

------------------------------
Thas Yuwaraj
------------------------------

Hi Thas.

I tend to partially agree with Robin on this.  If you plan on using the equipment for a pre-IND non-clinical study then you really need to consider the GLP validation because that would best align with your plan and would likely be seen as more relevant than a GMP validation in this case.

However, I think I start to disagree with Robin in her assessment of what your vendor is proposing.  I don't think that the vendor is proposing to validate your equipment to GLP standards but to have the validation of your equipment conducted under GLP standards which are potentially more relevant to the types of testing they will complete. 

Like it or not, many companies will not state that they conduct an equipment validation to GMP standards because they don't "manufacture" anything.  The will state that they work under GLP standards because they are scientifically analyzing the ability of equipment to perform a function not related to manufacturing.  While this might "muddy the waters" of what they are doing and claiming, the fact is that many test labs consider their process as a lab functionality, not a manufacturing functionality regardless of what the equipment is actually used to produce.

So I would say that if your lab offers a GLP study and not a GMP study, they are likely referencing the fact that the expected chain of custody and review and analysis and data gathering are all being done under the supervision of a quality department which should provide you the necessary data if the validation is ever questioned by the authorities.  So, if I were in your position and they were offering a "GLP" version I likely would go that route rather than a non-certified route.

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 13-Apr-2017 14:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Hello everyone,

we have been seeing a separate 'GLP fee' line item on recent sterilization validation and automatic cleaning validation quotes from external test laboratories. We understand that all these facilities perform the studies under GMP but are pushing GLP as a 'value add.'
Is this truly a requirement from regulatory authorities? I ask this because the GLP fee is not insignificant compared to the total cost.
GLP is touted to include QA master file tracking of samples, QA audit of test phase and final report. It should be noted that we, as manufacturer, also take on most of these tasks as part of our internal practice; however, we are not the subject matter experts when it comes to sterilization and automatic cleaning validation.

Any and all guidance will be much appreciated.

Cheers
Thas

------------------------------
Thas Yuwaraj
------------------------------

Thank you Robin and Victor for the detailed assessments. The clarification of the context from Victor is immensely valuable.

This "GLP fee" is associated with the test report (test plan and results) that we will receive from the cleaning and sterilization validation service provider. As Victor described, the activity does appear to ensure that "the expected chain of custody and review and analysis and data gathering are all being done under the supervision of a quality department which should provide you the necessary data if the validation is ever questioned by the authorities."
Have other members of this community seen request for GLP compliance records for their cleaning and sterilization validation reports from FDA reviewers (as part 510k reviews)?
I am also having bit of a cognitive dissonance because I expect this level of scrutiny when an external test laboratory conducts such tests per standards. 


------------------------------
Thas Yuwaraj
------------------------------

Original Message:
Sent: 13-Apr-2017 14:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Hello everyone,

we have been seeing a separate 'GLP fee' line item on recent sterilization validation and automatic cleaning validation quotes from external test laboratories. We understand that all these facilities perform the studies under GMP but are pushing GLP as a 'value add.'
Is this truly a requirement from regulatory authorities? I ask this because the GLP fee is not insignificant compared to the total cost.
GLP is touted to include QA master file tracking of samples, QA audit of test phase and final report. It should be noted that we, as manufacturer, also take on most of these tasks as part of our internal practice; however, we are not the subject matter experts when it comes to sterilization and automatic cleaning validation.

Any and all guidance will be much appreciated.

Cheers
Thas

------------------------------
Thas Yuwaraj
------------------------------

Hi Thas,
I totally agree with you! It appears that they don't believe in their own GMP quality at their laboratory.  If they don't trust their own GMP quality, why would they trust their own GLP quality? Very strange. I would suggest asking them for a copy of their SOPs to determine what they do for a GMP-quality report, and what they do for a "GLP"-quality report (I'm putting "GLP" in quotes because their system seems fishy to me!).

Sorry I can't answer your question about regulators asking about GLP compliance in these types of validation reports.

Best regards,
Robin


------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
robinguy@robinguy.com
------------------------------

Original Message:
Sent: 18-Apr-2017 11:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Thank you Robin and Victor for the detailed assessments. The clarification of the context from Victor is immensely valuable.

This "GLP fee" is associated with the test report (test plan and results) that we will receive from the cleaning and sterilization validation service provider. As Victor described, the activity does appear to ensure that "the expected chain of custody and review and analysis and data gathering are all being done under the supervision of a quality department which should provide you the necessary data if the validation is ever questioned by the authorities."
Have other members of this community seen request for GLP compliance records for their cleaning and sterilization validation reports from FDA reviewers (as part 510k reviews)?
I am also having bit of a cognitive dissonance because I expect this level of scrutiny when an external test laboratory conducts such tests per standards. 


------------------------------
Thas Yuwaraj
------------------------------

Original Message:
Sent: 13-Apr-2017 14:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Hello everyone,

we have been seeing a separate 'GLP fee' line item on recent sterilization validation and automatic cleaning validation quotes from external test laboratories. We understand that all these facilities perform the studies under GMP but are pushing GLP as a 'value add.'
Is this truly a requirement from regulatory authorities? I ask this because the GLP fee is not insignificant compared to the total cost.
GLP is touted to include QA master file tracking of samples, QA audit of test phase and final report. It should be noted that we, as manufacturer, also take on most of these tasks as part of our internal practice; however, we are not the subject matter experts when it comes to sterilization and automatic cleaning validation.

Any and all guidance will be much appreciated.

Cheers
Thas

------------------------------
Thas Yuwaraj
------------------------------

Hi Robin,
this line of thinking has led us to take the following approach with the vendor:
- we are going to do vendor audit and ensure that we are satisfied with their general processes (in the absence of the "GLP service" which is done for extra fee)
- if we are satisfied with our audit findings then we will opt out of the "GLP service" and rely on our vendor controls going forward
- I see this as one-time cost/effort that can avoid "GLP fee" every time we engage them -- which is quite often because of our product portfolio.

I must admit that this has not stood the test of an external audit. YMMV!

Thas

------------------------------
Thas Yuwaraj
------------------------------

Original Message:
Sent: 19-Apr-2017 06:02
From: Robin Guy
Subject: GLP fee for external laboratory based sterilization validation

Hi Thas,
I totally agree with you! It appears that they don't believe in their own GMP quality at their laboratory.  If they don't trust their own GMP quality, why would they trust their own GLP quality? Very strange. I would suggest asking them for a copy of their SOPs to determine what they do for a GMP-quality report, and what they do for a "GLP"-quality report (I'm putting "GLP" in quotes because their system seems fishy to me!).

Sorry I can't answer your question about regulators asking about GLP compliance in these types of validation reports.

Best regards,
Robin


------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
robinguy@robinguy.com
------------------------------

Original Message:
Sent: 18-Apr-2017 11:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Thank you Robin and Victor for the detailed assessments. The clarification of the context from Victor is immensely valuable.

This "GLP fee" is associated with the test report (test plan and results) that we will receive from the cleaning and sterilization validation service provider. As Victor described, the activity does appear to ensure that "the expected chain of custody and review and analysis and data gathering are all being done under the supervision of a quality department which should provide you the necessary data if the validation is ever questioned by the authorities."
Have other members of this community seen request for GLP compliance records for their cleaning and sterilization validation reports from FDA reviewers (as part 510k reviews)?
I am also having bit of a cognitive dissonance because I expect this level of scrutiny when an external test laboratory conducts such tests per standards. 


------------------------------
Thas Yuwaraj
------------------------------

Original Message:
Sent: 13-Apr-2017 14:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Hello everyone,

we have been seeing a separate 'GLP fee' line item on recent sterilization validation and automatic cleaning validation quotes from external test laboratories. We understand that all these facilities perform the studies under GMP but are pushing GLP as a 'value add.'
Is this truly a requirement from regulatory authorities? I ask this because the GLP fee is not insignificant compared to the total cost.
GLP is touted to include QA master file tracking of samples, QA audit of test phase and final report. It should be noted that we, as manufacturer, also take on most of these tasks as part of our internal practice; however, we are not the subject matter experts when it comes to sterilization and automatic cleaning validation.

Any and all guidance will be much appreciated.

Cheers
Thas

------------------------------
Thas Yuwaraj
------------------------------

Hi Thas,

I believe you are asking the wrong question, which is should you choose GLP or non-GLP. You should be asking is the study required to be GLP. If you are submitting the study to the US FDA as safety data in support of investigational use or a marketing authorization for your product, then the study must be GLP per 21 CFR 58. The choice is made for you.

Having audited laboratories that provide both GLP and non-GLP studies, I would say that the time and resources required for GLP are 4 to 8 times what they are for non-GLP. There is a reason they charge so much more for GLP, as with many things in life, you get what you pay for.

So why would anyone do a study non-GLP? Because it isn't required if it isn't being submitted as safety data to the FDA. Feasibility or development studies don't need to be GLP. The lab is just asking you if you intend to submit to FDA and therefore need it to be GLP. Based on your original question, "Is this truly a requirement from regulatory authorities?", sounds like the answer is yes (at least if it is going to US FDA).

Cheers,
Kevin

------------------------------
Kevin Hawkins, RAC
Director, Quality & Regulatory Affairs
Wilsonville OR
------------------------------

Original Message:
Sent: 20-Apr-2017 09:59
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Hi Robin,
this line of thinking has led us to take the following approach with the vendor:
- we are going to do vendor audit and ensure that we are satisfied with their general processes (in the absence of the "GLP service" which is done for extra fee)
- if we are satisfied with our audit findings then we will opt out of the "GLP service" and rely on our vendor controls going forward
- I see this as one-time cost/effort that can avoid "GLP fee" every time we engage them -- which is quite often because of our product portfolio.

I must admit that this has not stood the test of an external audit. YMMV!

Thas

------------------------------
Thas Yuwaraj
------------------------------

Original Message:
Sent: 19-Apr-2017 06:02
From: Robin Guy
Subject: GLP fee for external laboratory based sterilization validation

Hi Thas,
I totally agree with you! It appears that they don't believe in their own GMP quality at their laboratory.  If they don't trust their own GMP quality, why would they trust their own GLP quality? Very strange. I would suggest asking them for a copy of their SOPs to determine what they do for a GMP-quality report, and what they do for a "GLP"-quality report (I'm putting "GLP" in quotes because their system seems fishy to me!).

Sorry I can't answer your question about regulators asking about GLP compliance in these types of validation reports.

Best regards,
Robin


------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
robinguy@robinguy.com
------------------------------

Original Message:
Sent: 18-Apr-2017 11:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Thank you Robin and Victor for the detailed assessments. The clarification of the context from Victor is immensely valuable.

This "GLP fee" is associated with the test report (test plan and results) that we will receive from the cleaning and sterilization validation service provider. As Victor described, the activity does appear to ensure that "the expected chain of custody and review and analysis and data gathering are all being done under the supervision of a quality department which should provide you the necessary data if the validation is ever questioned by the authorities."
Have other members of this community seen request for GLP compliance records for their cleaning and sterilization validation reports from FDA reviewers (as part 510k reviews)?
I am also having bit of a cognitive dissonance because I expect this level of scrutiny when an external test laboratory conducts such tests per standards. 


------------------------------
Thas Yuwaraj
------------------------------

Original Message:
Sent: 13-Apr-2017 14:45
From: Thas Yuwaraj
Subject: GLP fee for external laboratory based sterilization validation

Hello everyone,

we have been seeing a separate 'GLP fee' line item on recent sterilization validation and automatic cleaning validation quotes from external test laboratories. We understand that all these facilities perform the studies under GMP but are pushing GLP as a 'value add.'
Is this truly a requirement from regulatory authorities? I ask this because the GLP fee is not insignificant compared to the total cost.
GLP is touted to include QA master file tracking of samples, QA audit of test phase and final report. It should be noted that we, as manufacturer, also take on most of these tasks as part of our internal practice; however, we are not the subject matter experts when it comes to sterilization and automatic cleaning validation.

Any and all guidance will be much appreciated.

Cheers
Thas

------------------------------
Thas Yuwaraj
------------------------------