Hi,
Firstly, as Ken rightly mentioned in her original post – there is no regulatory requirement for a PLD to get involved in investigations pertaining to routine manufacturing and testing.
Please correct me if wrong – the only "regulatory" responsibilities for a PLD are:
(a) acquiring NDC labeler code
(b) drug listing for all products being distributed under its labeler code
(c) ensuring cGMP compliance.
As such, it would be an overkill to have the PLD participate in regulatory decision-making for routine investigations at the manufacturing site. Specifically, an over enthusiastic PLD may not agree with the outcome of the investigation and request the manufacturer to re-investigate.
In contrast, a PLD would be interested in knowing the investigation outcomes for any product quality complaint originating from the market. This is especially true in case where the package insert has the PLD's toll-free number – in such cases, the PLD's in-house medical information team would log in the details, assign in-house case ID and share the information with the manufacturer/applicant for further investigation. Upon completion of the investigation, and based on the verbiage incorporated within applicable Quality Agreement, the manufacturer/applicant could share the investigation report/summary with the PLD – only for "archival purposes" and to administratively "close-out" the complaint at the PLD's end.
I would love to hear if you or other members have any suggestions.
Best,
Suhail
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Mohammed Suhail Chowdry
Sr. Regulatory Affairs Associate
New Jersey
United States
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Original Message:
Sent: 30-Jul-2020 12:11
From: Anonymous Member
Subject: Private Label Distributor Deviation Report Obligations
This message was posted by a user wishing to remain anonymous
Hi Mohammed,
Could you expand on the potential issues if the PLD is actively involved in the investigation itself?
Original Message:
Sent: 27-Jul-2020 15:10
From: Mohammed Suhail Chowdry
Subject: Private Label Distributor Deviation Report Obligations
Hi Ken,
Generally, Private Label Distributors (PLDs) are more concerned about investigation outcomes for product quality complaints and not necessarily all deviations, which would include - lab errors, atypical results, and OOS results that might occur during manufacturing, packaging, or testing of the product.
I agree with Richard. The manufacturer should promptly communicate any significant change or deviation to the PLD. The Quality Agreement should identify this within the responsibilities matrix. Additionally, you can limit the PLD's involvement to only being notified of any such events and then receiving the investigation summary. Any further participation with handling deviations, product complaints, etc. would have issues later, as you've rightly identified. You can include a statement like - manufacturer shall notify the PLD within (X) calendar days from the awareness/identification date of any significant deviation that might result in a market recall.
Regards,
Suhail
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Mohammed Suhail Chowdry
Sr. Regulatory Affairs Associate
New Jersey
United States
Original Message:
Sent: 27-Jul-2020 13:30
From: Ken Rose
Subject: Private Label Distributor Deviation Report Obligations
Hi Richard,
Thank you for replying. It's good to get another opinion. Our client does want some visibility into the manufacturer's processes, but that can be handled within a Quality Agreement. We were concerned from a regulatory perspective if our client didn't agree with how the resolution of a deviation was handled, what would be the regulatory impact.
Regards,
Ken
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Ken Rose
Painesville OH
United States
Original Message:
Sent: 27-Jul-2020 04:30
From: Richard Vincins
Subject: Private Label Distributor Deviation Report Obligations
Hello Ken,
I would agree with you that as a Private Label (Distributor) there is no no regulatory requirement they must be involved in the manufacturing activities or decisions made by the original manufacturer. This does and would depend on any agreements or contract made between the two parties such that if as the Private Labeler they want to take a more active role in what they are selling, then they would have those arrangements or agreements with the original manufacturer. Though as an original manufacturer, it would be nice to communicate to any Private Labeler if there are significant changes made to the finished device impacting any considerations for products placed on the market. In my experience, handling these type of manufacturing deviations or manufacturing changes would be handled through any agreements or contracts made with the original manufacturer.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 24-Jul-2020 12:28
From: Ken Rose
Subject: Private Label Distributor Deviation Report Obligations
Hello Everyone,
We have a client that is starting a Private Label Distributorship. The client is asking what regulatory obligation they would have on signing off on deviation reports from the manufacturer. I am saying that since they are a Private Label Distributor there is no regulatory requirement that they be involved in manufacturer deviation reports. There could be contractual desires to put clauses in the Quality Agreement or the Sales Agreement, but I do not think there is a regulatory requirement.
Has anyone else run into this issue. If so, how did you handle it?
Thank you,
Ken
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Ken Rose
Painesville OH
United States
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