MP based on the Ref. MP - Prep. Production Chain - creation

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

The creation of a new Medicinal Product based on the Ref. MP - Preparation Production Chain begins with a "basis for creation" enriched email notification with the topic "New MP based on the Ref. MP - Prep. Production Chain":

  • enriched email notification after the creation of the Medicinal Product based on the Ref. MP

Gathering of the documentation/data

Gathering of documentation and necessary data for the structural and narrative definition of a new Medicinal Product based on the Ref. MP - Preparation Production Chain can be done in advance, before the beginning of structural definition and subsequently when the Medicinal Product based on the Ref. MP - Preparation 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 Medicinal Product based on the Ref. MP - Preparation 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 Medicinal Product based on the Ref. MP - Preparation Production Chain and directory tree of replacement files does not exists in the eCTD Integral Information System and the only topic that can be used in the correspondence is "New MP based on the Ref. MP - Prep. Production Chain". Attached documents are classified and uploaded to the Corporate Documentation Cloud but they are not linked with the Medicinal Product based on the Ref. MP - Preparation Production Chain that is being created. Nevertheless, linking of all correspondence to the newly created Medicinal Product based on the Ref. MP - Preparation 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  Medicinal Product based on the Ref. MP - Preparation 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 Medicinal Product based on the Ref. MP - Preparation 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 Medicinal Product based on the Ref. MP - Preparation 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 / Medicinal Product Preparation 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 Medicinal Product based on the Ref. MP - Preparation 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 create and structurally define a Medicinal Product based on the Ref. MP - Preparation Production Chain following business processes must be performed in the following order:

  1. Generation/receipt of a "basis for creation" enriched email
  2. Selection of one "basis for creation" enriched email message and related correspondence on the sub-application form "Correspondence" of the application form "Corporate Entity creation / Preparation Production Chain / Structural Data"
  3. Definition of general structural data of the Medicinal Product based on the Ref. MP - Preparation Production Chain
  4. Definition of manufacturing operations and manufacturing sites 
  5. Definition of the  container(s) for the Marketed Medicinal Product
  6. Definition of Marketed Medicinal Product's Quality Control Analysis(s)
  7. 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 "basis for creation" regular/enriched email

When the Medicinal Product based on the Reference MP is assigned a status "completely structurally defined" an automatically generated enriched email notification is sent to the cmc entity person designated for the definition of the Medicinal Product based on the Reference MP with the information that the Medicinal Product based on the Reference MP - Preparation Production Chain has to be created using the newly defined Medicinal Product based on the Reference MP. 

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 started by choosing the menu item "Corporate Entity creation/Preparation Production Chain/Structural Data" on the "Corporate Entities" application module.

2. Selection of one "basis for creation" enriched email message and related correspondence

The process is initiated by choosing the menu item "Corporate Entity creation / Preparation Production Chain / Structural Data" on the "Corporate Entities" application module.

To initiate the creation of a new Preparation Production Chain, using the "Correspondence" sub-application form, the received "basis for creation" enriched notification relevant to the Preparation Production Chain being created must be selected from the non-processed correspondence documents.

When selecting a "basis for creation" enriched email, all related correspondence previously received relating to the same theme should also be checked.

All correspondence from then on must be made using enriched email messages and newly-introduced Medicinal Product based on the Reference MP - Preparation Production Chain as a 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 corresponding replacement files.

3. Definition of general structural data of the Medicinal Product based on the Ref. MP - Preparation Production Chain

After returning to the main application form, the Medicinal Product based on the Ref. Medicinal Product is automatically displayed.

Using the Marketed Substances Production Chains and LoV of impurities, the qualitative and quantitative composition of the Medicinal Product is defined.

For each position, it is indicated whether it is subject to the quality control procedure.

Using at least the minimal set of required data the Medicinal Product based on the Ref. MP - Preparation Production Chain is introduced into the eCTD Integral Information System and a core sequence, a directory tree of replacement narrative files and an enriched email notification to the designated cmc entity person are generated.

During the insertion of the record, the newly defined Medicinal Product based on the Reference MP - Preparation Production Chain automatically becomes the topic of all selected enriched emails and they can be seen when inserting additional data on the "Correspondence" sub-application form.

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

In the case the Marketed Substance Production Chain for active substance is has not yet been defined, the cmc entity person must wait for a enriched email notification informing him of its complete structural definition.

4. Definition of manufacturing operations and manufacturing sites

By selecting the type of production in the first raw:

  • Processing of sterile medicinal product - aseptically prepared
  • Processing of sterile medicinal product - terminally sterilized
  • Processing of non-sterile medicinal product

the remaining production steps are displayed.

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

5. Definition of the container(s) for the Marketed Medicinal Products

For the Medicinal Product based on the Reference MP, one or more Containers can be defined together with shelf life and storage conditions.

For each Container, a Marketed Medicinal Product is created with an appropriate directory tree with replacement narrative files for artwork of the immediate and secondary packaging.

6. Definition of Marketed Medicinal Product(s) quality control analysis(s)

Quality control analysis is defined by the selection of qualitative and quantitative positions that are subjected to quality control, as well as the physical and chemical properties that are controlled, along with the appropriate technique and method.

7. 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 Medicinal Product based on the Ref. MP - Preparation Production Chain is assigned the status "completely structurally defined".

At the end of the structural definition an automatically generated enriched email notification is sent to a top level management informing them about creation of a new Medicinal Product based on the Reference MP - Preparation Production Chain.

In which Dossier(s) the new Medicinal Product based on the Reference MP - Preparation Production Chain will be introduced is the decision of the top management.

7.1 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" 

7.2 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 defined". 

Additional data can be added on the same application form by clicking on the "Additional data" button and selecting the required Medicinal Product based on the Reference MP - Preparation Production Chain from the LoV of incompletely defined Medicinal Product based on the Reference MP - Preparation Production Chains. Previous enriched emails related to the selected Medicinal Product based on the Reference MP - Preparation Production Chain 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 Medicinal Product based on the Reference MP - Preparation 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 complete narrative definition of the Medicinal Product based on the Ref. MP - Preparation 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 Medicinal Product based on the Ref. MP - Preparation 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 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 / Preparation 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 Medicinal Product based on Ref. MP. - Preparation Production Chain is set to be "completely narratively defined".