How document templates can facilitate or prohibit multipurpose documents that can be reused throughout a product's and document's life cycle

1. How Document Templates can
Facilitate or Prohibit
Multipurpose of Documents
Michiel Stam – Manager Regulatory Operations
Qdossier B.V.

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
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3. Multipurpose
Avoid duplication of work
Single authoritative source
Know “where used”
Product life cycle management
Regulatory compliance
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Reuse of document contents in a different
context across products, regions and
formats

4. 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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5. Content and Context – Carrot and potato recipes
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Manufacturers
Competent
authorities
Production
process
(active)
substances
Drug
Products

6. Content and Context – Every item documented
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Manufacturers
Competent
authorities
Production
process
(active)
substances

7. Content and Context – Cross references
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Manufacturers
Competent
authorities
Production
process
(active)
substances

8. Content and Context – Branding
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Manufacturers
Competent
authorities
Production
process
(active)
substances

9. 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
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Context
of use

10. 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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11. Definition of subject
Discrete piece of content
Specific topic
Identifiable purpose
Stand-alone
Reuseable in various context
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12. 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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13. Facilitate multipurpose documents (II)
Supported by document management process
Store 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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14. 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>
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Option for single document, specific to the container
Option for multiple documents, specific and non-specific to the container
(preferred)

15. Document numbering
Exclude (sub)section numbering from eCTD names
Facilitate reuse across CTD module 3 and Asean CTD part II
Omit redundant numbering in eCTD
Consider cross-references!
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16. Document naming
Strong naming
Minimize contextual information
Specific enough to specify contents (future proof!)
Standardized naming variables
According to internal and external conventions
Harmonized naming
Across eDMS
Content plans
Document templates
Published output (e.g. electronic submissions or SharePoint)
Multiple document name types
eDMS name
(e)CTD name
Output file name
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17. 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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18. Submission content plan
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19. Harmonized naming
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20. 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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21. Facilitating Lean Authoring
Trained Authors
Contents according to defined location
Avoid contextual information
Proper use of Word features
Cross references, headers, headings, captions etc.
Template guiding information and examples
Authoring style
Granularity
Header information
Document naming
Cross-reference style
Contents expected
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22. 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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23. 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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24. Templates as part of RIM process
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Global tracking
system
Submission content
plan
Search eDMS docs
and templates
CTD document
template
Document
authoring
Document
storage
Electronic
submission
s
Health
Authority
Sharepoint
Cloning
Archive eCTD
viewer

25. Thank you !
Questions?
www.qdossier.com