how document templates can facilitate or prohibit multipurpose documents
DESCRIPTION
How document templates can facilitate or prohibit multipurpose documents that can be reused throughout a product's and document's life cycleTRANSCRIPT
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How Document Templates can Facilitate or Prohibit
Multipurpose of Documents
Michiel Stam – Manager Regulatory Operations
Qdossier B.V.
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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
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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
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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)
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Content and Context – Carrot and potato recipes
Manufacturers
Competentauthorities
Productionprocess
(active)substances
Drug Products
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Content and Context – Every item documented
Manufacturers
Competentauthorities
Productionprocess
(active)substances
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Content and Context – Cross references
Manufacturers
Competentauthorities
Productionprocess
(active)substances
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Content and Context – Branding
Manufacturers
Competentauthorities
Productionprocess
(active)substances
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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
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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
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Definition of subject
Discrete piece of content
Specific topic
Identifiable purpose
Stand-alone
Reuseable in various context
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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
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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
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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)
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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!
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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
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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
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Submission content plan
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Harmonized naming
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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
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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
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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?
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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?
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Templates as part of RIM process
Global tracking system
Submission content plan
Search eDMS docs and templates
CTD document template
Documentauthoring
Document storage
Electronic submission
s
Health Authority
SharepointCloningArchive eCTD
viewer
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Thank you !
Questions?
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