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• MES Projects in Japan, USA and Germany
• First South Asian projects
• Roll-out projects in USA and Australia
• HQ office relocation and regional GMP projects
• Open regional company in Singapore
• Start of the company in Bangkok, Thailand
• High growth in solutions business internationally
• First Projects in Thailand and China
• Regional Projects in Indonesia and Malaysia
• High Growth in compliance services regionally and wide range of solution projects
• Partnership for MES with Werum, Germany
• Factorytalk receives ISO certification
• Partnership for eQMS with MasterControl, US
• Partnership for eSubmissions with Lorenz, Germany
• Factorytalk received MasterControl Gold Partner Award
• Established ISPE Thailand affiliate
• HQ office expansion and new Regional and International Offices
2009 • First local MES and
eQMS Projects and office expansion
2010 2008 2013
2012 2011 2007 2005 2006 2004
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Today!
Factorytalk
Partners
Projects
>50 Clients
>20 Countries
>150,000 Man-hours
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Supporting compliance..
Assessment
• GAP Analysis / Audits
• GMP Health-Check
Planning
• URS • Facility Design • Validation • Risk
Assessments • Training &
Workshops • CSV and IT
strategy
Implementation
• Project Management • Validation services • QMS remediation • Supplier Audits • Technology
Solutions: − ERP − MES − eQMS − LIMS/LES
− eSubmissions
Inspection
• Pre inspection readiness
• Mock inspections • Submissions
Management • Audit / Inspection
support
Optimization
• Post audit support • Overseas market
development and sourcing
• Productivity / process improvement
• Supplier sourcing
GMP standards
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>2000yrs >1000yrs ~200yrs ~150yrs ~50yrs
~30yrs ~20yrs ~10yrs ~5yrs
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Impact on access to information
• 80% of employees waste an average of half an hour per
day retrieving information
~ at Factorytalk this equates to 1.3M THB/yr
• 60% spend an hour or more duplicating work
~ at Factorytalk this equates to 2M THB/yr
Total = 3.3M THB
*Source: BAE Systems
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ACTD
• ASEAN established the ASEAN Common Technical
Document (ACTD) to create harmonized
requirements and a common format for all
submissions of dossiers in the ASEAN countries.
• The ACTD is based on the European standard (CTD),
CTD format is required for the registration of all drug
products into EMEA regulated countries.
• Contents of Module 2 in CTD were separate in to
ACTD Part 2,3,4 as paper management during review
process is easier.
• TOCs aren’t required anymore in eCTD
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eCTD
Module 1
Regional Admin
Information
Module 3
Quality
Module 4
Nonclinical Study Reports
Module 5
Clinical Study Reports
Quality Overall
Summary Nonclinical Summary
Nonclinical Overview
Clinical Summary
Clinical Overview
Module 2
NOT Part of the CTD
The CTD
ICH M4
ACTD Part 1
ACTD Part 2
ACTD Part 3
ACTD Part 4
A
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Business Protocol
Prepare Submission
Application
eSubmission Identifier
Prepare the cover letter
and validation report
Delivery of the eCTD
Application at FDA (CD)
FDA : Feedback on Validation of Application
FDA : Start review process
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Regional Content
• Module 1 administrative and prescribing
information
- The content and numbering of Module 1 for Thailand is
modelled after the EU Module 1 content as described in the
2008 version of the EU Notice to Applicants. Additional
documents specifically required by Thailand not covered by the
EU structure is describe in 1.A Additional Data of TH Module 1
and Regional Specification
• Modules 2 to 5
- No change from ICH eCTD Specification.
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Handling of Empty or Missing eCTD Sections
• For new applications, including generic applications, detailed
statements justifying the absence of data or specific CTD
sections should be provided in the relevant Quality Overall
Summary and/or Nonclinical/Clinical Overviews e.g. Module 2.3,
2.4, or 2.5.
• For a generic application, there is no need to provide a
justification for content that is typically absent.
• Note that placeholder documents highlighting no relevant
content should not be placed in the eCTD structure.
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Bookmarks, TOCs, and Hyperlinks
• Bookmarks and/or TOCs make the review more efficient.
• The FDA recommends that documents with more than five pages and
with multiple sections should provide a Table of Contents, and/or if
appropriate, a Table of Tables, Table of Figures, etc. on the first page
of the document.
• Hyperlinks are recommended when they would aid the evaluation in
ways not already possible through the use of the eCTD index.xml and
document navigation aids.
• Applicants should consider when creating cross document hyperlinks
that they can cause confusion later in lifecycle and therefore be
distracting for an efficient review.
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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File Reuse
• The FDA accepts and encourages applicants to make active use of file reuse.
• Applicants should not submit the same document multiple times.
• File reuse should be used when
- a file is submitted multiple times within one sequence,
- a file already submitted in an earlier sequence is being referenced again,
- or if a file submitted in another application is being referenced in a new application.
• Please note that the FDA is implementing a flat repository structure to make
cross application referencing possible.
- Links to content provided in other applications simply need to be directed out of the current
application structure and into the structure of the corresponding application.
- All application will be stored using the eSubmission Identifier to make cross referencing
easily predictable and possible.
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Structure
•Naming conventions for the
content files are irrelevant for
electronic review
•All content must be
referenced
by the appropriate XML files
for efficient navigation.
•Applicants should concentrate
on providing precise but
informative leaf titles to
aid reviewers.
Prepare
Application eSubmission
Identifier Validation
report Delivery the application
Application feedback
Reviewing process
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eSubmission Identifier
• A request for an eSubmission identifier should made
via email. The request will require the following
information: - Licensee Number
- Description of Application.
- Dosage Form
- INN or Generic Name
- Strength
- WHO ATC Code
- Sequence Type
- Application form
- CPP (Optional)
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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eSubmission Identifier
• The eSubmission Identifier will be issued
within 10 days of application. The Applicant
must check on the THAI FDA online service
for a response informing them of their
eSubmission Identifier. After receiving the
identifier, the Applicant must then make an
appointment for submission within 30 days.
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Validation Criteria
• No major new or unusual validation criteria
developed from EU eCTD V3.2
• Other regions were analysed, compared and adopted
if suitable
• Detail validation criteria can be found at TH Regional
Specification and Validation Criteria
Prepare
Application eSubmission
Identifier Validation
report Delivery the application
Application feedback
Reviewing process
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Items worth noting
Validation Criteria
• Files and Folders - There are no naming conventions being validated
• ICH Backbone - File Reuse - Information is collected about references outside the
application and sequence as well as multiple references to a file within a sequence
• TH Regional - File Reuse
- Cover Letter must be New
- Information is collected when Application Form is not New
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Validation Tools
Most vendors offer free basic versions of their validation tools • No excuses for submitting applications that do not pass technical validation
• Make sure you validate on the media being submitted
• Validation should be limited to criteria specified by the FDA
- Some vendors provide extended profiles, these should not be provided with the
application
• List of validation tools will be provided on the eSubmission Website as
vendors provide evidence that they can sufficiently validate the FDA
requirements
• Current free version of validation tool being used by the FDA can be found at:
- http://www.lorenz.cc/esolutions/eValidator/ (Link also provided on FDA
eSubmission webpage)
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Business Protocol for Submitting
eCTD
Expected Structure of Submitted Media and Media
Formats • Expected structure of submitted media
- Content should be submitted in an application folder named after the eSubmission identifier.
- The sequence folder and its contents should be placed in this application folder.
- Large applications must be split and submitted on multiple items e.g. DVDs
- The overall folder structure should be included on each media so that content can be easily
merged
• Media formats
- The media formats acceptable when submitting an eCTD are:
o CD-R, DVD-RAM, DVD+R/-R,
- Ensure that you do not use:
o double-sided discs, rewritable discs or compressed or zipped files (except for validation
reports).
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Delivery of the eCTD Application
• The Applicant will need to make an appointment
through [email protected] and
deliver the application personally at the Division of
Policy System Development. The eCTD will be
validated and imported into the THAI FDA Review
System together with the applicant. Once accepted
and submitted, the applicant will be given back their
media to keep.
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Application feedback
• THAI FDA will inform applicants if there are
problems experienced during the upload of
an eCTD sequence.
• Confirmation of validation document will be
issue during appointment.
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Start Review Process
Initial Content Screening Process
Evaluation
Process
Administration Process
(include LoQ)
Issue Registration Certificate
Prepare Application
eSubmission Identifier
Validation report
Delivery the application
Application feedback
Reviewing process
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Technical Feedback
• 1 from 9 companies facing media failure
• 2 from 9 companies not passed validation
process of THAIFDA
• 2 from 9 companies have incomplete
Administrative information
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Thank you! Teerapong Cheepchol
T: +662-630-4525