Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

My experience comes from the medical device industry, but here is my take.  I always see the role of QA as one focused on implementing the processes required in adhering to good manufacturing practices. In pharma, GMPs come from the regulations while in the device industry, GMPs are written in an ISO standard. Quality is responsible for hosting audits and inspections. QA, in my experience, is responsible for CAPA investigations to answer your question.   Compliance is a legal function, but over the years compliance and quality assurance are also used interchangeably to cause more confusion, but I believe this depends on the stage of the company.  I come from a company where compliance is a strictly legal function (e.g. the in-house lawyers responsible for ensuring the company adheres to the GDPR , etc). But at the stage where a company needs in-house counsel, it should be quite a mature company but I've seen exceptions.  Regulatory affairs deals with communications with the government, for example, through pre-submission meetings and filing submissions.  In the device startup world, RA and QA are often combined. I shy away from using the term "compliance" in QA.  I have never worked in pharma so I'd be interested to hear what the division of labor is in that industry.  Hope it helps.

------------------------------
Karen Zhou
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Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

Hi Anon,

In the Pharma sector, QA and RA are usually separate entities. QA deals with the GMP. In some others QA also deals with health & safety or even HR.
In small companies you can see only one department (QA/RA).

It really depends on the people. If they are interested and they are versatile, you can combine them all to one. The problem is the work load.

I do not know the structure of your company, so I do not know what department can audit QA. Maybe R&D? Production?
This is a problem with companies that QA has all the departments under control.
As a wise man said "QA must appear only when there is a quality problem". It is not exactly true, but you got the meaning


------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

When asked by 'laymen' I tend to explain the difference between QA and RA as follows:

 QA focuses on process requirements, RA focuses on product requirements.

Of course this is only a rule of thumb and it does need disclaimers: it depends on local implementations and there are exceptions. Still, it works reasonably well as a starting point.

Compliance is a goal for both QA and RA. But indeed Compliance can also be a separate department. If so, they usually focus on legal aspects of the business,  they handle the stuff that is more general and not pharma/MD/IVD specific.

One more disclaimer: The above is mainly based on MD and IVD experience, not pharma.

------------------------------
Bart J
Netherlands
------------------------------

Original Message:
Sent: 29-May-2020 01:59
From: Spyros Drivelos
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

Hi Anon,

In the Pharma sector, QA and RA are usually separate entities. QA deals with the GMP. In some others QA also deals with health & safety or even HR.
In small companies you can see only one department (QA/RA).

It really depends on the people. If they are interested and they are versatile, you can combine them all to one. The problem is the work load.

I do not know the structure of your company, so I do not know what department can audit QA. Maybe R&D? Production?
This is a problem with companies that QA has all the departments under control.
As a wise man said "QA must appear only when there is a quality problem". It is not exactly true, but you got the meaning


------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

Hello Anon,

You have some already good advice, and I am sure you have done much looking around and research to try and find the split.  It is understood you are trying to keep them separate which in the pharma world you still have this luxury because in the medical device world those lines are getting more and more blurred if not non-existent.  In the few years working in pharma we usually separated the two (and for your three) this way:

- Regulatory Affairs (probably the easiest): responsible for regulatory submissions (NDA, ANDA, MAA, registrations), regulatory interface, regulatory strategy
- Quality Assurance (sometimes called Quality Control): responsible for overall GMP (I was going to say GMP compliance haha), quality system management, incoming testing of drug substances, label checking, product processes, batch release
- Compliance: responsible for post market, customer complaints, internal audits, maybe batch release, external audits, GMP compliance, one sitting in front of FDA during an inspection

Though in my experience Quality Assurance and Compliance were often the same or even regulatory affairs was the Coordinator during any type of regulatory inspection.  The important thing is defining this well within you own quality management system usually in form of job descriptions or such as a Quality Manual.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 29-May-2020 02:37
From: Bart Jungerius
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

When asked by 'laymen' I tend to explain the difference between QA and RA as follows:

 QA focuses on process requirements, RA focuses on product requirements.

Of course this is only a rule of thumb and it does need disclaimers: it depends on local implementations and there are exceptions. Still, it works reasonably well as a starting point.

Compliance is a goal for both QA and RA. But indeed Compliance can also be a separate department. If so, they usually focus on legal aspects of the business,  they handle the stuff that is more general and not pharma/MD/IVD specific.

One more disclaimer: The above is mainly based on MD and IVD experience, not pharma.

------------------------------
Bart J
Netherlands

Original Message:
Sent: 29-May-2020 01:59
From: Spyros Drivelos
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

Hi Anon,

In the Pharma sector, QA and RA are usually separate entities. QA deals with the GMP. In some others QA also deals with health & safety or even HR.
In small companies you can see only one department (QA/RA).

It really depends on the people. If they are interested and they are versatile, you can combine them all to one. The problem is the work load.

I do not know the structure of your company, so I do not know what department can audit QA. Maybe R&D? Production?
This is a problem with companies that QA has all the departments under control.
As a wise man said "QA must appear only when there is a quality problem". It is not exactly true, but you got the meaning


------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

Well, what an interesting set of responses to your question, Anonymous, and it seems that the answer depends a lot on personal experience. So, here is mine - as the head of Regulatory Affairs and Quality Assurance at a small start-up pharma. And, I am in the process of adding Compliance to that role. (Note that for RA, I report to the head of R&D, but for QA I report to the CEO.) For me, Regulatory Affairs is the nexus between the company and regulatory authorities. I translate regulations to the company and communicate the company's development program to the regulatory authorities. Quality Assurance provides guidance to the company on processes required to be compliant (an activity that is often confused with Compliance with a capital C) and monitors that compliance. Compliance (with a capital C) is a combined regulatory and legal oversight of post-marketing activities. One the regulatory side it is mostly about promotional activities and on the legal side it is about SEC, FTC, etc.

My view, to answer your direct question, is that QA tasks are the responsibility of the QA "department" and the QA organization is not beholden to RA or Compliance.

So, you see, there is probably no single right answer, but only a gestault of the separation of powers. At a small company, like the one I am in, there is no separation but everyone knows what I do in the company. As we grow, those activities will start to become silo'd. Other's experience may be different.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

Hello colleague
I think you are on the right path, trying to define and separate roles. QA's role is to ensure implementation/oversight of a quality system, which for the pharmaceutical industry includes compliance with cGMP. RA's role would be mostly related to interactions with the regulatory authority, updates on regulations (domestic and global), preparation of regulatory submissions, development of regulatory strategies, etc. Usually staff in QA has a closer look at technical/scientific aspects of all activities related to production, quality control, premises/equipment, and although they are not experts in all of these areas, they need to have enough background to understand the language and verify compliance, corrective actions, etc. RA staff usually do not have the same level of technical/scientific understanding of processes/activities and need to work very closely with QA. So, regarding your question about CAPA and complaints, I think it is QA's role.

------------------------------
Liliana Chocarro
LC PLUS CONSULTING INC
Mississauga ON
Canada
------------------------------

Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

Just an additional note: several of the respondents have stated that QA's responsibility is for GMP compliance. I haven't read much mention about responsibilities of QA for GCP, GLP or GVP, so let's broaden our discussion.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 29-May-2020 09:22
From: Liliana Chocarro
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

Hello colleague
I think you are on the right path, trying to define and separate roles. QA's role is to ensure implementation/oversight of a quality system, which for the pharmaceutical industry includes compliance with cGMP. RA's role would be mostly related to interactions with the regulatory authority, updates on regulations (domestic and global), preparation of regulatory submissions, development of regulatory strategies, etc. Usually staff in QA has a closer look at technical/scientific aspects of all activities related to production, quality control, premises/equipment, and although they are not experts in all of these areas, they need to have enough background to understand the language and verify compliance, corrective actions, etc. RA staff usually do not have the same level of technical/scientific understanding of processes/activities and need to work very closely with QA. So, regarding your question about CAPA and complaints, I think it is QA's role.

------------------------------
Liliana Chocarro
LC PLUS CONSULTING INC
Mississauga ON
Canada

Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

I tend to agree with Richard.
RA can also be involved in Promotions & Advertisement review and approval, and post-marketing requirements (if Pharmacovigilance or Medical Affairs teams are not available). Basically RA is every function that needs to report the drug information to the regulatory bodies.
QA is not the same as QC! Although people use it interchangeably. QA focuses on processes, while QC on product specs (it is like validation vs. verification). I am sure you can find other differences online.
Compliance is a vague function (like a project management but it's another topic). RA takes a compliance function as well (on regulatory requirements) and QA is a compliance in terms of internal or quality standards.

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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
------------------------------

Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?

This message was posted by a user wishing to remain anonymous

There is no requirement that QA, Compliance and RA needs to be separate. Having said that, I do have suggestions based on my practical experience on the roles of these functions if they are separate:

1. Let the interpretation of guidelines, regulations, CFR etc to be sole responsibility of the RA function. i.e. before a QA/Compliance person makes a decision consult with your RA person to make sure that the guideline or regulation is appropriately interpreted. Otherwise, I have seen disastrous implication to the business. QA/Compliance tend to over interpret and may lead to very unwarranted implications to the business.
2. QA and compliance roles should be oversight of GMP, GCP, Labs procedures, SOPs etc and making sure that the company adheres to the internal quality procedures.
 * includes vendor qualifications, incoming raw materials acceptance, auditing etc......
3. For a startup company, make sure that all your SOPs, quality procedures are written in collaboration with your RA function because the RA serves as the sole responsibility of interpretation of the regulations. guidelines etc. This is very important because, QA and compliance when write up these SOPs without the consultation of RA tend to be not realistic and sometimes too restrictive without any regulatory justification. As an example, a company's QA/compliance provided CAPAs to the District office after an inspection to correct certain issues without the consultation of RA. One of the listed items in CAPA was too restrictive and suspended all operations related to manufacturing of the product even though the RA function who had discussions with the review division head at the FDA based on interpretation of the regulations and guidelines that the product can be manufactured with only FEW restrictions and not suspend all operations which the QA/Compliance did and submitted this to the District office without knowing that the RA function has already talked to the review division HEAD. Later it was corrected and the manufacturing resumed, which the District office has no problems with it. In fact the District said we did not ask the company to suspend all operations that was voluntarily submitted by the company's QA/Compliance group. Hope this helps!
Original Message:
Sent: 28-May-2020 16:07
From: Anonymous Member
Subject: Defining the roles of QA vs Compliance vs Regulatory Affairs

This message was posted by a user wishing to remain anonymous

I'm currently working at new pharmaceutical manufacturer and we are struggling with determining the roles between Quality Assurance, the Compliance department, and Regulatory Affairs.  Much of our research has seen the combination of at least two or all three of the departments combined into one, however, we are trying to keep them separate. Also, when it comes to which department is auditing the QA tasks, such as CAPA effectiveness reviews and reports on client complaints, there is some debate.  Anyone have any suggestions?