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Lean authoring of module 3
The document discusses lean authoring in the context of regulatory dossiers, emphasizing the importance of efficient documentation to enhance traceability and reduce redundancy. It outlines the principles of lean authoring, including separating content from context, using consistent terminology, and applying document reuse across submissions. The benefits include improved communication, ease of updates, and reduced risk of regulatory rejection.
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Lean authoring of module 3
- 1. Lean authoring ofModule 3 Joyce van Gerven, Regulatory Affairs Manager, Qdossier B.V., The Netherlands Lodewijk Venhuizen, Senior Regulatory Affairs Manager, Crucell Switzerland AG, Switzerland
- 2. Content ©20140523 2Lean authoringof Module 3 What is Lean Authoring? •Why Lean Authoring? •Advantages of Lean Authoring How to apply Lean Authoring Lean Authoring General Lean Authoring Module 3 Real life examples Questions
- 3. What is LeanAuthoring?
- 4. Definition of LeanAuthoring ©20140523 4Lean authoring of Module 3 Split Content / Context Naming of documents Content of documents Headers and footers
- 5. Content carrier (e.g. document) Generalaspects 1 Understand the difference between documenting information for GMP versus regulatory dossier • Better to give a summary of a validation report than the report itself that included references to GMP documents, like named SOPs and internal Monographs Separate content from context of use Location of document in dossier or DMS Cross references to other content Branding within a content carrier Context of use
- 6. Content & Context- carrot and potato recipes Manufacturers Competent authoritiesDrug products Production process (active) substances
- 7. Content & Context- every item documented Manufacturers Competent authoritiesDrug products Production process (active) substances
- 8. Content & Context– cross references Manufacturers Competent authoritiesDrug products Production process (active) substances
- 9. Content & Context– cross references Manufacturers Competent authoritiesDrug products Production process (active) substances
- 10. Content & Context- Named product in named country for named submission type Manufacturers Competent authoritiesDrug products Production process (active) substances If you are not the intended recipient of this disk, you are hereby notified that any disclosure, copying, distribution or reliance upon the contents of this disk is strictly prohibited eCTD on <INN> Sequence <…..> Disk <x> of <n> <Application Number> <Type of submission> Marketing Authorisation Number(s): <Company logo> Applicant: Product Name: Date Sent: For technical issues contact <………@................................>
- 11. Content & Context- Named product in named country for named submission type Manufacturers Competent authoritiesDrug products Production process (active) substances If you are not the intended recipient of this disk, you are hereby notified that any disclosure, copying, distribution or reliance upon the contents of this disk is strictly prohibited eCTD on <INN> Sequence <…..> Disk <x> of <n> <Application Number> <Type of submission> Marketing Authorisation Number(s): <Company logo> Applicant: Product Name: Date Sent: For technical issues contact <………@................................> If you are not the intended recipient of this disk, you are hereby notified that any disclosure, copying, distribution or reliance upon the contents of this disk is strictly prohibited eCTD on <INN> Sequence <…..> Disk <x> of <n> <Application Number> <Type of submission> Marketing Authorisation Number(s): <Company logo> Applicant: Product Name: Date Sent: For technical issues contact <………@................................>
- 12. Lean Authoring? ©20140523 12Leanauthoring of Module 3 What do we see in dossiers • Company names and Logos • Branding • Same information at multiple locations Where to improve • Mind information that is likely to change over time • Mind information that is likely to be different between countries Definition of detailed / multiple choice • How lean should you write
- 13. Why Lean Authoring? ©2014052313Lean authoring of Module 3 Resulting in poor: •Retrieval of documents •Impedes traceability Resulting in redundant: •Writing •Review •Approval •Publishing •Hyperlinking •QC
- 14. Advantages of LeanAuthoring ©20140523 14Lean authoring of Module 3 Document can be reused across countries Documents can be reused across products Improves effective communication and review process Improves consistency in messages •Within and across documents •Within and across products •Within and across countries
- 15. Advantages of LeanAuthoring ©20140523 15Lean authoring of Module 3 Eases future updates of documents Eases future preparation of submissions Eases retrieval of information in a document repository and submission Reduces the chance of rejection by authorities Less variations • Manufacturer’s only described in S2.1 and P3.1 • Manufacturing process not mentioning manufacturers • Analytical procedures not mentioning manufacturers
- 16. How to applyLean Authoring
- 17. What is importantfor dossier preparation? ©20140523 17Lean authoring of Module 3 Which marketing license to be obtained Which claims to be supported Which documents to be used • Content • Identification • Format • Header • Cross references How to communicate? • Verbally • Written • eMail • Meeting minutes • Project plans • Document management systems (trackability, traceability)
- 18. ©20140523 Lean authoringof Module 3 18 from Qdossier
- 19. ©20140523 Lean authoringof Module 3 19 from Qdossier
- 20. ©20140523 Lean authoringof Module 3 20 Dossier Plan Lifecycle
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- 22. Lean Authoring ©20140523 22Leanauthoring of Module 3 Provide information only once in a dossier only in one document Provide it at the correct (or most appropriate) location Be concise Use the same terms; prevent use of synonyms Refer to the data provided elsewhere rather than repeat
- 23. Lean Authoring –Rules Consistency ©20140523 23Lean authoring of Module 3 All information in the dossier needs to be consistent •The less repetition, the smaller the risk for inconsistencies Re-use documents across products to •Reduce the risk of inconsistencies and compliance issues •Increase the possibility for grouping and work sharing across products (only EU)
- 24. Lean authoring –Rules Cross references ©20140523 24Lean authoring of Module 3 Cross-references to other products in time independent documents to justify the quality, safety or efficacy. • Not advisable, don’t do it • It puts your product at risk when something unforeseen happens to the referenced product
- 25. Lean authoring –General ©20140523 25Lean authoring of Module 3 Apply default Word numbering: • 4.4 Lyophilisation and stabilisation Instead of 3.2.S.2.2.4.4 Lyophilisation and stabilisation • Figure 1 Manufacturing process flow diagram Instead of Figure 3.2.S.2.2-1 Manufacturing process flow diagram • Apply default Word References • Tables and figures references in text using cross-references
- 26. Lean authoring –Text ©20140523 26Lean authoring of Module 3 Words that should be avoided: • In order • Assume • New/Old • Possibly • Please What else should be avoided • Long sentences • Sentences starting with • With this variation/submission … • …we (the company) shows • We (the company) would like to …
- 27. Lean authoring Module3 Real life examples
- 28. Pro Easy to navigate whenusing eCTD .xml or NeeS ToC Only small document to revise for variation Better reusability of documents between products Con Difficult to navigate when using Windows Explorer Large document to revise for variation all content might be reviewed again ©20140523 Lean authoring of Module 3 28 Pros and cons of high document granularity
- 29. Granularity and appearanceof documents ©20140523 29Lean authoring of Module 3 Per document •Corresponding to the content plan One doc per section Multiple docs per section
- 30. Single vs. MultipleGranularity ©20140523 30Lean authoring of Module 3 3.2.P.8.1 Stability Summary and Conclusion Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui 3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitment Nam liber tempor cum soluta nobis eleifend option congue nihil imperdiet doming id quod mazim placerat facer possim assum. Typi non habent claritatem insitam; est usus legentis in iis qui facit eorum claritatem. Investigationes demonstraverunt lectores legere me lius quod ii legunt saepius. Claritas est etiam processus dynamicus, qui sequitur mutationem consuetudium lectorum. Mirum est notare quam littera gothica, quam nunc putamus parum claram, anteposuerit litterarum formas humanitatis per seacula quarta decima et quinta decima. Eodem modo typi, qui nunc nobis videntur parum clari, fiant sollemnes in futurum. 3.2.P.8.3 Stability Data Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui Nam liber tempor cum soluta nobis eleifend option congue nihil imperdiet doming id quod mazim placerat facer possim assum. Typi non habent claritatem insitam; est usus legentis in iis qui facit eorum claritatem. Investigationes demonstraverunt lectores legere me lius quod ii legunt saepius. Claritas est etiam processus dynamicus, qui sequitur mutationem consuetudium lectorum. Mirum est notare quam littera gothica, quam nunc putamus parum claram, anteposuerit litterarum formas humanitatis per seacula quarta decima et quinta decima. Eodem modo Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure
- 31. Appearance of documents ©2014052331Lean authoring of Module 3 Document-specific headers, so: •NOT Uniform across a dossier! •NOT Referencing the dossier!
- 32. Appearance of documents ©2014052332Lean authoring of Module 3 Not this But this
- 33. Appearance of documents ©2014052333Lean authoring of Module 3 Proper styles •Heading numbering not including CTD section # •Table/figure numbering not including section #
- 34. ©20140523 Lean authoringof Module 3 34 Lifecycle example 0000 Pilot Scale Initial stability 0001 Pilot Scale Extension stability Long-term 12 M stability data 0010 Commercial scale Initial stability 0011 Commercial Scale Extension stability Long-term 24 M stability data Current View Long-term 12 M stability data Long-term 24 M stability data Long-term 12 M stability data commercial scale Long-term 12 M stability data commercial scale Long-term 24 M stability data commercial scale Long-term 24 M stability data commercial scale Short-term stability data Short-term stability data Short-term stability data commercial scale Short-term stability data commercial scale
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- 36. ©20140523 36Lean authoringof Module 3 Set up of new dossier for influenza vaccine Inherited dossier Baseline dossier (to go) No strict separation DS/DP Defined the DS and DP Usage of (translated) SOPs Summaries and general description Local documents No local documents, but summaries Usage of Brandname throughout dossier Use generic name Inconsistent naming Naming convention introduced (DS; DP) Master files/ full dossiers suppliers Make list of important parameters (summary) Long text Shorter text, summaries, translations QOS QOS rewritten
- 37. What could Qdossierdo? ©20140523 37Lean authoring of Module 3 Place the information at the correct dossier section • Crucell and Qdossier understanding of the content • Repetition of information in DS and DP Summarise lengthy dossier sections (content) • Creation of new (e)CTD documents • Ease the upload into the company’s ‘documentation’ system Overview of all Documents • Important having the overview of documents from the old dossier to the new dossier • Creation of the Content Plan (ToC, etc)
- 38. CRO’s and Client’sagreements ©20140523 38Lean authoring of Module 3 Delivery of a clear source data package Good agreements in who is doing what Goal setting Manage the internal teams for review of the documents Knowledge of the content •Check that nothing is missing •No changes introduced, even minor
- 39. Challenges and solutions ©2014052339Lean authoring of Module 3 Understanding of the content for Q-Dossier •Questions on content •New definitions Tracker of the questions and answers •GAP analysis Meetings •Kick off •Life meetings (F2F) •Weekly TC
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- 41. Rolling out atCrucell ©20140523 41Lean authoring of Module 3 Experience with HA • Documents used for submission • Feedback HA Next steps other vaccines Crucell • Project started on lean and eCTD • Experience will be used
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Editor's Notes
- #6 It is very important to understand that a regulatory dossier is reviewed to obtain a marketing license per product, while the manufacturers are inspected for GMP compliance. Therefore do not mix up regulatory documentation with GMP documentation. Be careful with including references to named GMP documents. Better to indicate that a topic is subject to GMP and therefore covered by valid GMP certificates. If SOPs have to be submitted as part of a Method validation package, it is not subject to regulatory review, but required to repeat the tests by the agency. As a result, these documents are to be located in 32R and not in 32S or 32P. It is also better to create separate regulatory documents for analytical procedures rather than submitting the GMP-documents.
- #18 Content plan: refer to earlier session of the conference
- #24 This looks like to have a link to variations ... why is this for lean authoring?
- #35 20130226
- #38 New documents will be created, therefore you don't want to miss information. Some information will be moved to other parts.
- #41 Joyce will have a question: What I was wondering … after the project what have you done with the experience and what we have provided?
- #42 Tell about the experience of our submission to AIFA on the dossier for Adimmune intro-inflexal V Epaxal started project to introduce eCTD with Q-Dossier; Usage of templates, lean writing will be introduced for next projects …