Regulatory Open Forum

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

Hi Julie,
I'm not aware of any "regulatory" prohibition to appoint a consultant as the Management Representative.  In fact, the regulation does not prohibit delegation.  I believe the key question is - can it be outsourced?  By experience I've never seen a company appoint a consultant as the Mgt Rep - considering the level of responsibility and authority of this position within the organization; however, my opinion is irrelevant form a legal and regulatory standpoint.  It may be useful to understand from members if there is a precedent, such as FDA citations of other on this matter.

FDA states in the QSR preamble (Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations) - that Management with executive responsibility is that level of management that has the authority to establish and make changes to the company quality policy. The establishment of quality objectives, the translation of such objectives into actual methods and procedures, and the implementation of the quality system may be delegated. The regulation does not prohibit the delegation. However, it is the responsibility of the highest level of management to establish the quality policy and to ensure that it is followed.  (See United States v. Dotterweich, 320 U.S. 277 (1943), and United States v. Park, 421 U.S. 658 (1975).)

The Mgt representative must be a member of the organization-management and is appointed by Mgt with Executive Responsibility.  This appointment must be documented.

In summary, delegation of these responsibilities are not prohibited, but careful considerations must be taken; including potential conflicts of interest.  In my opinion a company should not outsource such responsibility and authority, but again, it's a matter of what legal/regulatory precedents have been established, if any. 

It is important to note that top management  are those FDA will target  to enjoin, fine, or prosecute in the event of major noncompliance.  See, for example, United States v. Prigmore, 1996 WL 46430 (D. Mass, 1996); United States v. C.R. Bard, Inc. 848 F. Supp. 287 (D. Mass. 1994); and United States v. Pagones, No. 88-0581-CR (S.D. Fla. 1988)

Again, I encourage members to continue to comment on this subject and share any regulatory/legal precedents, if possible.

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

Hi Julie,
I'm not aware of any "regulatory" prohibition to appoint a consultant as the Management Representative.  In fact, the regulation does not prohibit delegation.  I believe the key question is - can it be outsourced?  By experience I've never seen a company appoint a consultant as the Mgt Rep - considering the level of responsibility and authority of this position within the organization; however, my opinion is irrelevant form a legal and regulatory standpoint.  It may be useful to understand from members if there is a precedent, such as FDA citations of other on this matter.

FDA states in the QSR preamble (Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations) - that Management with executive responsibility is that level of management that has the authority to establish and make changes to the company quality policy. The establishment of quality objectives, the translation of such objectives into actual methods and procedures, and the implementation of the quality system may be delegated. The regulation does not prohibit the delegation. However, it is the responsibility of the highest level of management to establish the quality policy and to ensure that it is followed.  (See United States v. Dotterweich, 320 U.S. 277 (1943), and United States v. Park, 421 U.S. 658 (1975).)

The Mgt representative must be a member of the organization-management and is appointed by Mgt with Executive Responsibility.  This appointment must be documented.

In summary, delegation of these responsibilities are not prohibited, but careful considerations must be taken; including potential conflicts of interest.  In my opinion a company should not outsource such responsibility and authority, but again, it's a matter of what legal/regulatory precedents have been established, if any. 

It is important to note that top management  are those FDA will target  to enjoin, fine, or prosecute in the event of major noncompliance.  See, for example, United States v. Prigmore, 1996 WL 46430 (D. Mass, 1996); United States v. C.R. Bard, Inc. 848 F. Supp. 287 (D. Mass. 1994); and United States v. Pagones, No. 88-0581-CR (S.D. Fla. 1988)

Again, I encourage members to continue to comment on this subject and share any regulatory/legal precedents, if possible.

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------

This is an interesting topic that I wish I had more time to discuss, but a notified body is playing a fairly large role in my life right now, so I'll just share some hurried thoughts/questions. In spite of the references to notified bodies, I believe we are talking about 21 CFR Part 820?  Here are some pertinent passages:

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

It seems clear to me that the authority to establish or make changes to the quality policy and quality system cannot be outsourced.

3) Management representative.  Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.

These roles are different than those of "management with executive responsibility." I am not sure why they cannot be outsourced.

21CFR 820 is part of the FDA's medical device regulations. See Parts 210-11 for similar FDA regulations applicable to pharmaceuticals.

-------------------------------------------
Julie Omohundro RAC
RAQA Infrastructure Services
Durham NC
United States



Original Message:
Sent: 03-03-2012 14:00
From: Roland Cooke
Subject: management responsibility

From a Notified Body perspective, I would agree with Richard. The use of consultants to support QA / RA activities is extremely common. But that's a different animal.

I think there's a clue in the title Management Responsibility. You can always outsource activities, you can never outsource responsibilities.

Thus top management should be the people to answer questions relating to their responsibilities, not the consultant. I've only had to enforce this on a handful of occasions over the years (since consultants generally know this), things tend to get rather exciting at that point.

I have seen a few examples where the consultants are formally brought into the company as part-time employees, which may make it workable.


-------------------------------------------
Roland Cooke
SGS Systems & Services Certification
-------------------------------------------






Original Message:
Sent: 03-02-2012 14:35
From: Karen Mullin
Subject: management responsibility

Hi there, I'm wondering if someone can clarify something for me regarding what is an apparently widely accepted practice in smaller bio-tech and pharmaceutical companies.  That is, the practice of outsourcing Quality to consultants.  My interpretation of 21 CFR 820.20(3) indicates that an actual employee of the company is required to be responsible for the application of the Quality System and the approval of Quality functions.  Common practice however, has this function being filled by consultants.  

My questions are:

1.  Do the current federal regulations prohibit the outsourcing of the lead Quality function (i.e., "Head of Quality")?

2.  Does 21 CFR 820 only apply to medical device manufacturers, or is it (as it is my understanding) more widely applicable to all GMP operations including bio-pharmaceuticals?

I am fairly new to the study of Regulatory Affairs, although I have been employed in GMP Pharmaceuticals for well over a decade.

-------------------------------------------
Karen Mullin
Meridian Biogroup, LLC
Frederick MD
United States
-------------------------------------------