Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All, 

Would like to know which functional area leads the serialization process at your companies during the development and commercial stages?

Development Stage: Packaging Development
Commercial Stage: Operational areas

Same at your sites?

THANKS!

Good day Anon,

In my experience the Quality group like quality engineering leads and manages the process for sterilisation validation.  Once the sterilisation validation is completed, the process is then "handed over", lead, and managed by the Operations group.  The Operations group may be a separate individual which manages the sterilisation process such as finished goods being shipped to steriliser and then back to the warehouse.  I have also seen the Shipping department or distribution managing the sterilisation process as they would handle the movement of goods from the company, to the steriliser, and then to the warehouse.  Usually there is a Quality Assurance sign-off of the sterilisation batch record(s) to ensure all requirements have been met and the product is released for distribution.

With that said, those would typically be who leads and/or manages the processes, but there are many other functions or departments involved in the sterilisation process.  As you say during the development stage there is design engineering, packaging engineering, packaging development, quality, etc.  Then during the sterilisation process there is operations, manufacturing engineering, the supplier (as applicable), purchasing, quality, etc.  Also not those involved with the sterilisation process should have the training, knowledge, and competency to perform the tasks as well.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 11-Aug-2022 13:02
From: Anonymous Member
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

This message was posted by a user wishing to remain anonymous

Dear All,

Would like to know which functional area leads the serialization process at your companies during the development and commercial stages?

Development Stage: Packaging Development
Commercial Stage: Operational areas

Same at your sites?

THANKS!

Wait... was that sTerilization or seriAlization?  Like, who decides if the product should have a serial number, and who assigns the next number in sequence?

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 12-Aug-2022 03:45
From: Richard Vincins
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

Good day Anon,

In my experience the Quality group like quality engineering leads and manages the process for sterilisation validation.  Once the sterilisation validation is completed, the process is then "handed over", lead, and managed by the Operations group.  The Operations group may be a separate individual which manages the sterilisation process such as finished goods being shipped to steriliser and then back to the warehouse.  I have also seen the Shipping department or distribution managing the sterilisation process as they would handle the movement of goods from the company, to the steriliser, and then to the warehouse.  Usually there is a Quality Assurance sign-off of the sterilisation batch record(s) to ensure all requirements have been met and the product is released for distribution.

With that said, those would typically be who leads and/or manages the processes, but there are many other functions or departments involved in the sterilisation process.  As you say during the development stage there is design engineering, packaging engineering, packaging development, quality, etc.  Then during the sterilisation process there is operations, manufacturing engineering, the supplier (as applicable), purchasing, quality, etc.  Also not those involved with the sterilisation process should have the training, knowledge, and competency to perform the tasks as well.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Aug-2022 13:02
From: Anonymous Member
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

This message was posted by a user wishing to remain anonymous

Dear All,

Would like to know which functional area leads the serialization process at your companies during the development and commercial stages?

Development Stage: Packaging Development
Commercial Stage: Operational areas

Same at your sites?

THANKS!

Good morning, 

I mean the serialization process. The one related to complying with DSCSA regulations for Drugs.

I would like to know which functional area leads the serialization process at your companies during the development and commercial stages?

Development Stage: Packaging Development
Commercial Stage: Operational areas

Same at your sites?

THANKS!





------------------------------
SANDRA MOSQUERA
Regulatory Affairs Director
------------------------------

Original Message:
Sent: 12-Aug-2022 11:19
From: Anne LeBlanc
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

Wait... was that sTerilization or seriAlization?  Like, who decides if the product should have a serial number, and who assigns the next number in sequence?

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 12-Aug-2022 03:45
From: Richard Vincins
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

Good day Anon,

In my experience the Quality group like quality engineering leads and manages the process for sterilisation validation.  Once the sterilisation validation is completed, the process is then "handed over", lead, and managed by the Operations group.  The Operations group may be a separate individual which manages the sterilisation process such as finished goods being shipped to steriliser and then back to the warehouse.  I have also seen the Shipping department or distribution managing the sterilisation process as they would handle the movement of goods from the company, to the steriliser, and then to the warehouse.  Usually there is a Quality Assurance sign-off of the sterilisation batch record(s) to ensure all requirements have been met and the product is released for distribution.

With that said, those would typically be who leads and/or manages the processes, but there are many other functions or departments involved in the sterilisation process.  As you say during the development stage there is design engineering, packaging engineering, packaging development, quality, etc.  Then during the sterilisation process there is operations, manufacturing engineering, the supplier (as applicable), purchasing, quality, etc.  Also not those involved with the sterilisation process should have the training, knowledge, and competency to perform the tasks as well.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Aug-2022 13:02
From: Anonymous Member
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

This message was posted by a user wishing to remain anonymous

Dear All,

Would like to know which functional area leads the serialization process at your companies during the development and commercial stages?

Development Stage: Packaging Development
Commercial Stage: Operational areas

Same at your sites?

THANKS!

Supply chain, part of manufacturing, is responsible for all aspects at my company.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 11-Aug-2022 13:02
From: Anonymous Member
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

This message was posted by a user wishing to remain anonymous

Dear All,

Would like to know which functional area leads the serialization process at your companies during the development and commercial stages?

Development Stage: Packaging Development
Commercial Stage: Operational areas

Same at your sites?

THANKS!

Oops sorry my bad, read it wrong.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 13-Aug-2022 11:14
From: Glen Park
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

Supply chain, part of manufacturing, is responsible for all aspects at my company.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 11-Aug-2022 13:02
From: Anonymous Member
Subject: FUNCTIONAL AREAS - SERIALIZATION PROCESS - QUICK QUESTION

This message was posted by a user wishing to remain anonymous

Dear All,

Would like to know which functional area leads the serialization process at your companies during the development and commercial stages?

Development Stage: Packaging Development
Commercial Stage: Operational areas

Same at your sites?

THANKS!