CTD CONVERSIONS & DOCUMENT AUTHORING - SAAPI · CTD Conversions. Document Authoring Reusability of Data. 1. Dossier Consolidation . 1.1 Review of Product Correspondence History 1.2

CTD CONVERSIONS & DOCUMENT AUTHORING

Henriette Vienings Thursday, 14 April 2016

SAAPI Conference – “ Success through Synergy” CSIR International Convention Centre Pretoria, Gauteng, South Africa

CTD Conversions

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© MRA Regulatory Consultants (MRA) | 2016

Conversion Project | Schematic Overview

Regulatory expectation: All dossiers to be in CTD Format by 01 June 20161

12.26 CTD Implementation Roadmap v6 | Medicines Control Council | February 2016

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1. Dossier Consolidation

1.1 Review of Product Correspondence History

1.2 Superseding of Approved Information in the dossier

1.3 Reviewing Consolidation possibilities at time of Conversion


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2. Digitisation

2.1 Organising & Scanning 2.2 Verification & Quality Check

• Image & Content • Legibility

2.3 Image Processing

2.3 Image Processing

2.3.1 File & Folder Structure and naming conventions applied

2.3.2 Creating eCTD-Ready documents

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3. Creating CTD Baseline

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3.1 Granulating documents to CTD requirements & creating content assignment record

3.2 Collating & Creating Module 1

3.3 Performing Due Diligence for Update requirements

3.4 Update approved content to CTD Requirements - Authoring

3.5 Incorporate Type A amendments

3.6 Creating Amendment Schedule

4. Content Updates

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4.1 Type B Amendments – notifications • Include sections with related Type A amendments that have been included in

the Baseline with clear amendment schedule instructions for updating the approved dossier content.

4.2 Action Type C amendments – applications for approval

• Examples: Updating PI & PILs Amending Registration Certificates Changing / Adding Manufacturers

• If extensive changes are being made, e.g. large sections of 3.2.S & 3.2.P are

affected – update entire dossier for evaluation.

5. Publishing & Submission

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5.1 Publishing & Quality Review

• eCTD Requirements & Validation – Future Option1

• Paper Requirements3,4

5.2 Printing, Collating, Binding

• Copies needed : MCC, in-house etc.

1 2.26 CTD Implementation Roadmap v6 | Medicines Control Council | February 2016 3 2.24 Guidance General Module 1 v5 | Medicines Control Council | August 2012, pp. 8 4 2.01 General Information Guideline v8 | Medicines Control Council | August 2012, pp.16

6. Project Closure

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Electronic Documentation & Hard Copies • Published Outputs – e.g. eCTD, print versions, pdf, etc. • Reference documents • Working documents – e.g. MS Word, MS Excel, pdf, etc. Documents, be they electronic or printed versions, need to correspond exactly. Filing systems – be they for electronic file management and , or hard copies should allow for easy correlation of documents/data through common attributes in metadata / file labelling to support auditing functions and maintain data integrity5.

5ISO16175 (3 parts) v1 | 2010 / SANS16175 (3 parts) v1 | 2014

CTD Conversions • Ensure that amendments are submitted to the correct

units within Medicines Control Council (MCC) + provide additional copies when more than one unit is involved in the evaluation of the amendment2,4.

• Do not submit CTD conversions that do not involve Type B (partial update) or Type C (full update) amendments2.

• Refer to ITG minutes for retrospective and on-going guidance on difficulties being experienced with conversions and amendments, by MCC and industry.

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2Summary of ITG Meeting, 08.03.2016, pp.3 42.01 General Information Guideline v8 | Medicines Control Council | August 2012, pp.16, pp. 25

Document Authoring

User Expertise

& Support

Functions

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Hardware, Software, EDMS, publishing software

Subject Matter Experts, Regulatory Affairs Experts, Regulatory Operations Experts

Trained authors with technical expertise and sound operations support

Guidance Documents • CTD content -, structure - and formatting requirements are

defined by the ICH.

• Technical content is largely harmonised and addressed in the ICH guidelines but some regional exceptions exist – refer Regional guidances, e.g. administrative guidance documents, stability guidelines (Zone Conditions), biowaiver and dissolution requirements etc.

• International Conference on Harmonisation: http://www.ich.org/products/guidelines.html

• Medicines Control Council Guidelines: http://www.mccza.com/Publications/Index/1

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http://www.ich.org/products/guidelines.html

http://www.mccza.com/Publications/Index/1

Using the Tools…

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Anyone operating equipment of any sort should be trained & certified before use!

Software Use

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• MS Word & pdf must be well understood to enable navigation and optimal file functionality, i.e. bookmarking, cross-referencing, hyperlinking, optimising, embedding fonts etc.

• Standard fonts, font sizes, pdf settings, file granularity & file naming conventions are all clearly defined in ICH and MCC Guidelines.

• CTD File Templates should be created and protected to allow authors ease of access to pre-formatted writing aids.

• Templates can contain extracts from or references to technical guidelines, such as the basic ICH requirements for a specific section with the addition of the MCC’s Pharmaceutical -, Biological - or Complementary Medicine QSE guidelines.

Reusability of Data • Core data sets should be generated and maintained for

products, irrespective of which market they are being sold in, to manage change control effectively.

• Common Data sets exist across dossiers and CTD sections, e.g.: • m1 – manufacturers’ licenses, GMP certificates, CoPPs, etc. • m3 – DMFs, Analytical Method Validation etc.

• Regulatory Information Management (RIM) is key in leveraging the benefits from data reusability and tracking content in submissions to manage change control over life-cycle.

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RIM & EDMS • DIA Reference Model provides a framework for RIM system

development

• Electronic Document Management Systems (EDMS) support, inter alia:

• data integrity functions such as user-function/role management

• audit trails across document lifecycle (versions) and reproduction (children)

• Content assignment tracking across submissions and lifecycles thereof, including multi-region activities.

• The discontinuation or withdrawal of records must be managed – how to correctly “dispose” of information is critically important.

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[email protected] | 083 435-4453 012 803-6223 |-5955 |-1039

Thank you for your attention!

Any Questions?

mailto:[email protected]

References | Acknowledgements

• References: 1. http://www.mccza.com/documents/5247e69e2.26_CTD_implementation_road_map_Feb16_v6.pdf 2. http://www.mccza.com/NewsEvents | ITG Meeting Summaries 3. http://www.mccza.com/documents/e1959c9e2.24_Guidance_General_Module_1_Jul12_v5.pdf 4. http://www.mccza.com/documents/1d9c57df2.01_General_information_Jul12_v8_showing_changes.pdf 5. ISO16175 v1 | 2010 / SANS16175 v1 | 2014

• Acknowledgements: • Gratitude to the MRA consulting team for the knowledge and experience

shared. • The Industry Task Group (ITG) for valuable work done in sharing

information and experiences with industry.

http://www.mccza.com/documents/5247e69e2.26_CTD_implementation_road_map_Feb16_v6.pdf

http://www.mccza.com/NewsEvents

http://www.mccza.com/documents/e1959c9e2.24_Guidance_General_Module_1_Jul12_v5.pdf

http://www.mccza.com/documents/1d9c57df2.01_General_information_Jul12_v8_showing_changes.pdf

Intellectual Property Notice

This presentation or parts thereof may be protected under the Copyright Act no 98 of 1978 of South Africa and under the Berne Convention and may not be reproduced, copied, adapted or disseminated either in part or whole without the written consent of the copyright owner, in any territory.