Regulatory Open Forum

Hello,
I am a medical device QA specialist working within a company that is developing a drug-device combination product. I am looking for either advice, or a referral to a good source of information on best practices for setting up a combination QMS (part 211 and 820*). I understand the basics - that we can comply with 211 or 820 and then supplement that system with the few items from the other set of regulations. My question lies in the application of this, practically, for the QMS. For example, Personnel and Training are covered in both regulations. Does it make the most sense to have universal training procedure that is applicable to all departments/operations? Or is there a compelling reason to have a Pharma training procedure and a Device training procedure? Similarly, for document management - assigning document numbers, review and approval, revision control - should there be one central management system that assigns numbers and tracks revisions for all types of documents, or is there a compelling reason to have a Pharma document management system and a device document management system?
My gut tells me the answer is to have only one system, but I am looking for feedback on what is common within the industry and if you have any experience with pros or cons of either scenario. I would appreciate if anyone can point me to a good resource where I can further research the topic, if you know of one. 

*note that our company doesn't only have to comply with 211 and 820...of course, we have to comply with part 11, part 50, 312 etc when those are applicable.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Have a look at AAMI TIR48:2015 "Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products". With kindest regards,

------------------------------
Ary Saaman
Director, Regulatory Affairs
Lausanne
Switzerland
------------------------------

Original Message:
Sent: 10-Jun-2020 12:57
From: Erica Livingston
Subject: Best Practices for Combination Product QMS

Hello,
I am a medical device QA specialist working within a company that is developing a drug-device combination product. I am looking for either advice, or a referral to a good source of information on best practices for setting up a combination QMS (part 211 and 820*). I understand the basics - that we can comply with 211 or 820 and then supplement that system with the few items from the other set of regulations. My question lies in the application of this, practically, for the QMS. For example, Personnel and Training are covered in both regulations. Does it make the most sense to have universal training procedure that is applicable to all departments/operations? Or is there a compelling reason to have a Pharma training procedure and a Device training procedure? Similarly, for document management - assigning document numbers, review and approval, revision control - should there be one central management system that assigns numbers and tracks revisions for all types of documents, or is there a compelling reason to have a Pharma document management system and a device document management system?
My gut tells me the answer is to have only one system, but I am looking for feedback on what is common within the industry and if you have any experience with pros or cons of either scenario. I would appreciate if anyone can point me to a good resource where I can further research the topic, if you know of one.

*note that our company doesn't only have to comply with 211 and 820...of course, we have to comply with part 11, part 50, 312 etc when those are applicable.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Thank you. I will look into it.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 10-Jun-2020 13:37
From: Ary Saaman
Subject: Best Practices for Combination Product QMS

Have a look at AAMI TIR48:2015 "Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products". With kindest regards,

------------------------------
Ary Saaman
Director, Regulatory Affairs
Lausanne
Switzerland

Original Message:
Sent: 10-Jun-2020 12:57
From: Erica Livingston
Subject: Best Practices for Combination Product QMS

Hello,
I am a medical device QA specialist working within a company that is developing a drug-device combination product. I am looking for either advice, or a referral to a good source of information on best practices for setting up a combination QMS (part 211 and 820*). I understand the basics - that we can comply with 211 or 820 and then supplement that system with the few items from the other set of regulations. My question lies in the application of this, practically, for the QMS. For example, Personnel and Training are covered in both regulations. Does it make the most sense to have universal training procedure that is applicable to all departments/operations? Or is there a compelling reason to have a Pharma training procedure and a Device training procedure? Similarly, for document management - assigning document numbers, review and approval, revision control - should there be one central management system that assigns numbers and tracks revisions for all types of documents, or is there a compelling reason to have a Pharma document management system and a device document management system?
My gut tells me the answer is to have only one system, but I am looking for feedback on what is common within the industry and if you have any experience with pros or cons of either scenario. I would appreciate if anyone can point me to a good resource where I can further research the topic, if you know of one.

*note that our company doesn't only have to comply with 211 and 820...of course, we have to comply with part 11, part 50, 312 etc when those are applicable.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

HI Erica,

Since FDA has already announced their intention to supplant 21 CFR 820 with ISO 13485, I recommend being aware of both as you build your QMS.

I recommend being strategic when developing procedures so common needs are covered by a single procedure, e.g., Training, Doc Control, CAPA, etc. Remember procedures detail what needs to be done, not necessarily all of the granular transactions beneath. WIs are for the details underneath.

For your Doc Control tool, I strongly recommend going with one that is adaptable and user friendly - check other threads on RAPS community board for recommendations. Don't let a tool run your life, actively design your UI to meet the varied needs of the cross functional team. There are many off the shelf tools that can help you build and maintain your QMS, but be shrewd where you want tools. At a minimum, I recommend using robust commercial tools for Doc Control, CAPA, Training, and Production, of course.

Persevere.

------------------------------
Adam Atherton
Farragut TN
United States
------------------------------

Original Message:
Sent: 10-Jun-2020 12:57
From: Erica Livingston
Subject: Best Practices for Combination Product QMS

Hello,
I am a medical device QA specialist working within a company that is developing a drug-device combination product. I am looking for either advice, or a referral to a good source of information on best practices for setting up a combination QMS (part 211 and 820*). I understand the basics - that we can comply with 211 or 820 and then supplement that system with the few items from the other set of regulations. My question lies in the application of this, practically, for the QMS. For example, Personnel and Training are covered in both regulations. Does it make the most sense to have universal training procedure that is applicable to all departments/operations? Or is there a compelling reason to have a Pharma training procedure and a Device training procedure? Similarly, for document management - assigning document numbers, review and approval, revision control - should there be one central management system that assigns numbers and tracks revisions for all types of documents, or is there a compelling reason to have a Pharma document management system and a device document management system?
My gut tells me the answer is to have only one system, but I am looking for feedback on what is common within the industry and if you have any experience with pros or cons of either scenario. I would appreciate if anyone can point me to a good resource where I can further research the topic, if you know of one.

*note that our company doesn't only have to comply with 211 and 820...of course, we have to comply with part 11, part 50, 312 etc when those are applicable.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Hi Erica,

These are great questions. My recommendation, in addition to those already provided, would be to start with the regulation that your product is most likely to led by, more specifically:

• if your product is a device with a drug component, your single system should be based off of 820 (and possibly 13485). 
• if your product is a drug with a device component, your single system should be based off of 211
• if you have a mixture of the above, I would recommend you use the regulation the leadership team is most familiar with. 
  

One system containing all of the elements needed would be the best not only for ease of maintenance, but for also demonstrating compliance. If you have multiple systems, it is easier for errors to occur on determining which procedure to use and how to justify the use of that procedure. Don't provide the opportunity for additional compliance issues if at all possible. 

I'd be happy to answer any additional questions you may have. Good Luck!

------------------------------
Andrea Pilon Artman, MS, CQE, RAC
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com
------------------------------

Original Message:
Sent: 10-Jun-2020 12:57
From: Erica Livingston
Subject: Best Practices for Combination Product QMS

Hello,
I am a medical device QA specialist working within a company that is developing a drug-device combination product. I am looking for either advice, or a referral to a good source of information on best practices for setting up a combination QMS (part 211 and 820*). I understand the basics - that we can comply with 211 or 820 and then supplement that system with the few items from the other set of regulations. My question lies in the application of this, practically, for the QMS. For example, Personnel and Training are covered in both regulations. Does it make the most sense to have universal training procedure that is applicable to all departments/operations? Or is there a compelling reason to have a Pharma training procedure and a Device training procedure? Similarly, for document management - assigning document numbers, review and approval, revision control - should there be one central management system that assigns numbers and tracks revisions for all types of documents, or is there a compelling reason to have a Pharma document management system and a device document management system?
My gut tells me the answer is to have only one system, but I am looking for feedback on what is common within the industry and if you have any experience with pros or cons of either scenario. I would appreciate if anyone can point me to a good resource where I can further research the topic, if you know of one.

*note that our company doesn't only have to comply with 211 and 820...of course, we have to comply with part 11, part 50, 312 etc when those are applicable.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

First, I would caution against the blanket statement that your organization doesn't need to comply with cGMP/QSR. While you don't have to comply with the conventional manufacturing-related requirements, such as validation and cleaning of manufacturing equipment, FDA has always expected virtual companies to comply with every provision related to a function that the virtual company engages in: at a minimum, you need an independent QAU, purchasing controls and supplier qualification (including reviewing the cGMP/QSR systems of your suppliers), a CAPA system including trending, a reporting system, and regular management reviews of all your Quality Systems.

Because of the intersection of these Quality Systems, a training that omits drug GMPs or device QSRs (or Q10 and ICH), is likely to be inadequate. I urge you to combine the training.

See Current Good Manufacturing Practice Requirements for Combination Products  and Guidance on Contract Manufacturing Arrangements - Quality Agreements

Just this week, FDA posted a newly issued compliance program, Inspections of CDER-led or CDRH-led Combination Products.

• The 46-page document lays out FDA's intended implementation of the compliance program; inspectional operations and reporting considerations; sampling and analytical testing expectations; regulatory and administrative strategy; and an explanation of center responsibilities.
• FDA says the compliance program focuses mainly on single-entity and co-packaged combination products that feature drug and device or biological product and device constituent parts.
• Combination product manufacturers may demonstrate compliance with current good manufacture practice (CGMP) requirements through one of two ways: compliance with all applicable CGMPs or by following a streamlined approach in which drug CGMPs or device quality system regulation and specific "called-out provisions" are followed.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 10-Jun-2020 12:57
From: Erica Livingston
Subject: Best Practices for Combination Product QMS

Hello,
I am a medical device QA specialist working within a company that is developing a drug-device combination product. I am looking for either advice, or a referral to a good source of information on best practices for setting up a combination QMS (part 211 and 820*). I understand the basics - that we can comply with 211 or 820 and then supplement that system with the few items from the other set of regulations. My question lies in the application of this, practically, for the QMS. For example, Personnel and Training are covered in both regulations. Does it make the most sense to have universal training procedure that is applicable to all departments/operations? Or is there a compelling reason to have a Pharma training procedure and a Device training procedure? Similarly, for document management - assigning document numbers, review and approval, revision control - should there be one central management system that assigns numbers and tracks revisions for all types of documents, or is there a compelling reason to have a Pharma document management system and a device document management system?
My gut tells me the answer is to have only one system, but I am looking for feedback on what is common within the industry and if you have any experience with pros or cons of either scenario. I would appreciate if anyone can point me to a good resource where I can further research the topic, if you know of one.

*note that our company doesn't only have to comply with 211 and 820...of course, we have to comply with part 11, part 50, 312 etc when those are applicable.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 6/10/2020 12:57:00 PM
From: Erica Livingston
Subject: Best Practices for Combination Product QMS

Hello,
I am a medical device QA specialist working within a company that is developing a drug-device combination product. I am looking for either advice, or a referral to a good source of information on best practices for setting up a combination QMS (part 211 and 820*). I understand the basics - that we can comply with 211 or 820 and then supplement that system with the few items from the other set of regulations. My question lies in the application of this, practically, for the QMS. For example, Personnel and Training are covered in both regulations. Does it make the most sense to have universal training procedure that is applicable to all departments/operations? Or is there a compelling reason to have a Pharma training procedure and a Device training procedure? Similarly, for document management - assigning document numbers, review and approval, revision control - should there be one central management system that assigns numbers and tracks revisions for all types of documents, or is there a compelling reason to have a Pharma document management system and a device document management system?
My gut tells me the answer is to have only one system, but I am looking for feedback on what is common within the industry and if you have any experience with pros or cons of either scenario. I would appreciate if anyone can point me to a good resource where I can further research the topic, if you know of one. 

*note that our company doesn't only have to comply with 211 and 820...of course, we have to comply with part 11, part 50, 312 etc when those are applicable.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------