Marketed Substance Production Chain - creation

  • Gathering of the documentation/data
  • Structural definition
  • Narrative definition

Since the initial Marketed Substance - Production Chain, consisting only of the distributing Organization, is defined during the creation of the corresponding  Marketed Substance this step represents a further elaboration of the definition of the Marketed Substance - Production Chain.

This step in the definition of the Marketed Substance - Production Chain begins with a "basis for creation" enriched email with the topic "New Marketed Substance - Production Chain":

  • enriched email notification after the creation of the new Marketed Substance and associated initial definition of the Marketed Substance - Production Chain
  • enriched email notification after the creation of another initial Marketed Substance - Production Chain for compendial Marketed Substances

Other documents that may be necessary for structural and narrative definition of the Marketed Substance - Production Chain are:

  • entity definition documents for participating manufacturing Organizations
  • entity definition documents for the starting material for the manufacture of Marketed Substances
  • stability tests

Gathering of the documentation/data

Gathering of documentation and necessary data for the structural and narrative definition of a new Marketed Substance - Production Chain can be done in advance, before the beginning of structural definition and subsequently when the Marketed Substance - Production Chain has become a topic in the enriched email correspondence.

Before the beginning of the structural definition

Gathering of documentation related to the creation of a new Marketed Substance - Production Chain is a process that can begin before the receipt of the "basis for creation"  enriched email and subsequent beginning of the structural definition. During that period database record for the new Marketed Substance - Production Chain and directory tree of replacement narrative files does not exists in the eCTD Integral Information System and the only topic that can be used in the correspondence is "New Marketed Substance - Production Chain". Attached documents are classified and uploaded to the Corporate Documentation Cloud but they are not linked with the Marketed Substance -Production Chain that is being created. Nevertheless, linking of all correspondence to the newly created Marketed Substance - Production Chain is essential and it can be done when the structural definition is started.

After the beginning of the structural definition

The cmc entity person begins the process of  Marketed Substance - Production Chain structural definition right after receiving the "basis for creation" enriched email. When selecting a "basis for creation" enriched email on the "correspondence" sub-application form, all related correspondence previously received relating to the Marketed Substance - Production Chain being created should also be selected.

During the insertion of the record into the eCTD Integral Information System a core sequence and a directory tree of replacement narrative files are generated and the newly defined Marketed Substance - Production Chain automatically becomes the topic of the "basis for creation" enriched email and all selected previously received enriched emails. That can be seen when inserting additional data on the "correspondence" sub-application form.

Previously received attachments/documents have to be manually assigned to the corresponding replacement files using the application form "Corporate Entity creation / Marketed Substance - Production Chain / Narrative data". The process is explained in the narrative definition section.

All correspondence from then on should be conducted using enriched email messages and the newly-created Marketed Substance - Production Chain as the topic.

During the subsequent correspondence and classification of the attachment(s), attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement files.

Structural definition

In order to further structurally define a Marketed Substance - Production Chain following business processes must be performed in the following order:

  1. Generation/receipt of a "basis for creation" regular/enriched email
  2. Selection of one "basis for creation" enriched email notification on the sub-application form "Correspondence" of the application form "Corporate Entity creation / Marketed Substance - Production Chain / Structural Data"
  3. Definition of manufacturing operations for the production of the Marketed Substance
  4. Definition of containers for the Marketed Substance
  5. Definition of starting materials for the production of the Marketed Substance
  6. Completion of the structural definition
    1. Complete structural definition during the first session
    2. Complete structural definition in several sessions

1. Generation/receipt of a enriched email notification

The enriched email notification automatically sent to the designated cmc entity person:

  • after the creation of the first distributing Organization of the new Marketed Substance
  • after the creation of another distributing Organization of the Marketed Substance

If necessary, additional correspondence using the same topic and subtopic can be made in order to clarify certain details. When all details are clarified, the structural definition process can be initiated by choosing the menu item "Corporate Entity creation/Marketed Substance -Production Chain/Structural Data" on the "Corporate Entities" application module.

2. Selection of one "basis for creation" enriched email notification

To complete the creation of the new Marketed Substance - Production Chain, using the "Correspondence" sub-application form, received enriched email notification relevant to the Marketed Substance - Production Chain being created must be selected from the non-processed correspondence documents.

3. Definition of manufacturing operations for the production of the Marketed Substance

At the beginning, the LoV of incompletely structurally defined Marketed Substances - Production Chains is displayed.

By double clicking on the required Marketed Substance - Production Chain, the general data together with the distributing Organization, defined during the definition of the Marketed Substance, are displayed.

For each production step, a manufacturing Organization must be selected using the LOV, displaying only Organizations with appropriate GxP.

If required, the creation of an additional manufacturing Organization(s) can be initiated by clicking the button "New Manufacturer" which automatically generates a "basis for creation" enriched email notification.

4. Definition of Containers for the Marketed Substance

For a Marketed Substance, one or more Containers can be defined along with shelf life and storage conditions.

5. Definition of starting materials for the production of the Marketed Substance

All the ingredients and their roles are specified for the production of the Marketed Substance using their production chains.

An initial directory tree with replacement narrative files for the Marketed Substance - Production Chain was introduced when the Distributor is defined during the structural definition of the Marketed Substance.

As structural data of the Marketed Substance - Production Chain are added into the eCTD Integral Information System, corresponding directory trees with replacement narrative files are simultaneously added.

6. Completion of the structural definition

The structural definition process can be completed in two ways:

  1. In one session when all structural data are defined
  2. in several sessions where
    1. in the first session only minimal data set and maybe some of the additional data are defined
    2. in the  next session(s) where remaining additional data are defined

Upon completion of the structural definition process, the Marketed Substance - Production Chain is assigned the status "completely structurally defined". 

At the same time, the Substance track is completed and progress is made in the Medicinal Product track. Based on the business rules:

  • for Innovative Active Substance, an automatic enriched email notification is sent to:
    • either the pre-clinical entity persons responsible for the definition of the first Pre-Clinical Tests or the
    • cmc entity person responsible for the definition of the  Innovative Medicinal Product - Preparation Production Chain 
      with the information that the new Marketed Substance - Production Chain is completely structurally defined
  • for (Generic) Active Substance of the Ref. Medicinal Product, an automatically generated enriched email automatic notification is sent to:
    • either the cmc entity person responsible for the definition of the Generic Investigational Medicinal Product - Preparation Production Chain or the
    • cmc entity person responsible for the definition of the Medicinal Product based on Ref. MP - Preparation Production Chain
      with information that the new Marketed Substance - Production Chain is completely structurally defined

6.1 Complete structural definition during the first session

The minimal data set denoted with (*) is prerequisite for the insertion of the record into the eCTD Integral information System.

If the minimal data set requirement is met, then confirmation of the complete structural definition is prompted. If the complete structural definition is confirmed the record is inserted into the database of the eCTD Integral Information System with the status "completely structurally defined" with the ability to be used to define corporate entities of the higher level.

6.2 Complete structural definition in several sessions

In the first session only the minimal data set and maybe some additional data are defined. At the end of the session, confirmation of the complete structural definition is prompted. If the answer is negative, the record is inserted and the status of the entity is set to "incompletely structurally defined". 

Additional data can be added as many times as needed in the same application form by clicking on the "Additional data" button and selecting the required Marketed Substance - Production Chain from the LoV of incompletely defined Marketed Substance -Production Chains. Previous enriched emails related to the selected entity can be seen on the "correspondence" sub-application form. 

The structural definition is completed when a positive response is given to the prompt for a complete structural definition. The Marketed Substance - Production Chain is assigned the status "completely structurally defined" with the ability to be used to define corporate entities of the higher level.

Narrative definition

The designated cmc entity person is responsible for the complete narrative definition of the Marketed Substance - Production Chain.

The eCTD documents can be either:

  • created by the designated cmc entity person and manually uploaded to the Corporate Documentation Cloud
    and/or
  • collected from related Business Partners via email correspondence and automatically uploaded to the Corporate Documentation Cloud during the enriched email processing of the Business Partner's regular email messages. 

Therefore, in order to narratively define a Marketed Substance - Production Chain following business processes must be performed:

  1. Creation of eCTD documents and manual uploading to the Corporate Documentation Cloud
    and/or
  2. Collection of eCTD documents via email correspondence and automatic uploading to the Corporate Documentation Cloud
  3. Completion of the process

1. Creation of eCTD documents and manual uploading to the Corporate Documentation Cloud

Using any regular text processor eCTD documents have to be created and pdf files generated for the uploading to the Corporate Documentation Cloud. If required, the process of verification by a senior manager can be included upon request.

The process is initiated by choosing the menu item "Corporate Entity creation / Marketed Substance - Production Chain / Narrative Data" on the "Corporate Entities" application module.

Other than that, the process is same as described in the "Substance - creation" page of this site, here.

2. Collection of eCTD documents via email and automatic uploading to the Corporate Documentation Cloud

In case the eCTD documents were originally generated by the Business Partner, they can be obtained via email correspondence. During the processing of such a Business Partner's regular email message by the Enriched Email and using the email attachments classification, they are automatically uploaded to the Corporate Documentation Cloud.

The process is same as described in the "Substance - creation" page of this site, here.

3. Completion of the process

When all mandatory replacement files in the directory tree are replaced with the written eCTD files, the process ends automatically and the Marketed Substance - Production Chain is set to be "completely structurally and narratively defined".