how document templates can facilitate or prohibit multipurpose documents

How Document Templates can Facilitate or Prohibit

Multipurpose of Documents

Michiel Stam – Manager Regulatory Operations

Qdossier B.V.

04/12/2023 www.qdossier.com - proprietary 2

Agenda

Multipurpose & Templates

Content and Context of use

Metadata and subject definition

Facilitating multipurpose documents

Template granularity, naming and numbering

Submission content plan

Harmonised naming

Control of templates

Location of contents


Multipurpose

Avoid duplication of work

Single authoritative source

Know “where used”

Product life cycle management

Regulatory compliance

Reuse of document contents in a different context across products, regions and formats


About document templates

Capture predefined contents

Define styles, headers and headings

Provides guidance and example text

Captures descriptive information about contents

Part of system for organizing documents by subject

Focus on word-processed format (electronic media)


Content and Context – Carrot and potato recipes

Manufacturers

Competentauthorities

Productionprocess

(active)substances

Drug Products

http://images.cookingwithmykid.com.s3.amazonaws.com/2010/07/dished-out.jpg


Content and Context – Every item documented

Manufacturers


Productionprocess

(active)substances



Content and Context – Cross references

Manufacturers


Productionprocess

(active)substances



Content and Context – Branding

Manufacturers


Productionprocess

(active)substances



Context of use

Content carrier (e.g. document)

Location of

document in dossier or DMS

Cross references to other documents

Branding within a content carrier

Contextof use


Template metadata selection

No out-of-the box system available

Roles and responsibilities

Storage, retrieval and permission control

Usage across tools

To describe content only (subject)Contextual metadata in eDMS doc properties only


Definition of subject

Discrete piece of content

Specific topic

Identifiable purpose

Stand-alone

Reuseable in various context


Facilitating multipurpose documents (I)

Templates:Well defined template granularity

Strong document naming

Generic cross-references (exchangeable destination)

Standardized document contents

Guidance, training and standardization:

Metadata

Lean authoring

Versioning

Supported by submission content plan:Document naming

Outline and granularity

Metadata and context of use

Relations between documents in context of use


Facilitate multipurpose documents (II)

Supported by document management processStore and locate templates and documents

Capture and define document naming and properties

Version control of templates and documents

Manage document locations

Maintain relationships between documents

Supported by training and monitoring

04/12/2023 www.qdossier.com - proprietary

Template granularity

Separation of reusable and submission-specific contents

Multiple granularity options:Single or multiple docs per CTD section

Specific or non-specific to the <subject> (e.g. drug product)

P.1 Description <container name>

P.7 <container name>

P.7 <free text> <container name>

P.7 <free text>

14

Option for single document, specific to the container

Option for multiple documents, specific and non-specific to the container (preferred)


Document numbering

Exclude (sub)section numbering from eCTD namesFacilitate reuse across CTD module 3 and Asean CTD part II

Omit redundant numbering in eCTD

Consider cross-references!


Document naming

Strong namingMinimize contextual information

Specific enough to specify contents (future proof!)

Standardized naming variables

According to internal and external conventions

Harmonized namingAcross eDMS

Content plans

Document templates

Published output (e.g. electronic submissions or SharePoint)

Multiple document name typeseDMS name

(e)CTD name

Output file name


Multipurpose naming

Container part fit for multiple container closure systems, across multiple products and regions:

3.2.P.7 Cap 3ml Vial Qdrug

3.2.P.7 Cap 3ml Vial Qdrug

P.7 Cap 3ml Vial Qdrug

P.7 Cap 3ml Vial

P.7 Cap Vial

P.7 Vial Cap 13mm


Harmonized naming


Control of templates and documents

How to manage template versions?Existing document is current, finalized and approved

Keep track of changes

Ownership of multipurpose templates

• Authorization and approval of draft documents

Review procedure not limited to contents only

Contents in context of multipurpose

Metadata


Facilitating Lean Authoring

Trained Authors

Contents according to defined location

Avoid contextual information

Proper use of Word featuresCross references, headers, headings, captions etc.

Template guiding information and examplesAuthoring style

Granularity

Header information

Document naming

Cross-reference style

Contents expected


Location of contents (I)

Defined by template, however..

Stability data intermediates appears in: Intermediates section

Stability section

Art 46 Statement appears as:- Addendum to the Cover Letter?- Addendum to M.2.5 Clinical Overview?


Location of contents (II)

Batch numbering in 3.2.P.3.3 and not together with batch analyses in 3.2.P.5.4

Stability conclusions only in 3.2.S.7.1 and 3.2.P.8.1 (not in other stability sections)

Process validation on intermediates:Included in S.2.4 Intermediates?

Or in S.2.5 Process validation?

Or S.2.6 Manufacturing process development?


Templates as part of RIM process

Global tracking system


Search eDMS docs and templates

CTD document template

Documentauthoring

Document storage

Electronic submission

s

Health Authority

SharepointCloningArchive eCTD

viewer

Thank you !

Questions?

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how document templates can facilitate or prohibit multipurpose documents

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