Specifications for eCTD Validation Criteria 2.2: PDF Checks

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FDA implemented eCTD validation criteria 2.2 on April 30, 2013. This version of the validation criteria includes PDF checks to ensure compliance with FDA PDF Specifications V2.0, Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications, ICH eCTD Specification V3.2.2, ICH Q&A, as well as promote general good practice to ensure reviewability.

Sponsors preparing eCTD submission documents should review and update internal PDF rendition and publishing standards to incorporate these criteria and reduce the chance and frequency of validation errors appearing in eCTD submissions.

A description of each PDF check and the associated corrective actions are provided here:

Failed to Process PDF Contents

Problem – You have submitted a document with contents that cannot be processed, e.g. a corrupted or invalid PDF document.

Corrective Action – Resubmit a corrected leaf in a future submission with the operation attribute of “Replace” and an updated valid PDF file.

Non-standard Font (not embedded)

Problem – You have used a non-standard font and failed to fully embed the font. You should limit fonts to standard fonts. If you use non-standard fonts you should fully embed them in the PDF file.

Corrective Action – Resubmit a corrected leaf in a future submission with the operation attribute of “Replace” and an updated PDF file with all non-standard fonts embedded.

PDF Security Used

Problem – You have submitted a PDF file with security settings that limit the ability to select text or graphics, or make other changes. This prevents agencies from copying text and taking other actions with submitted documents. (Not applicable for FDA Forms)

Corrective Action – Resubmit a corrected leaf in a future submission with the operation attribute of “Replace” and an updated PDF file without restrictions.

PDF Version of Document is Incorrect

Problem – You have submitted a document using a PDF version that is not consistent with ICH/regional guidance.

Corrective Action – No corrective action is necessary. Modify your SOPs to ensure that documents in future submissions conform to the published standards.

PDF Does not Have ‘Fast Web Access’ Active

Problem – You have submitted a PDF that has been created without ‘Fast Web Access’ active.

Corrective Action – Ensure that documents in future submissions are created with the ‘Fast Web Access’ option.

PDF Opening Settings not Optimal

Problem – You have submitted a PDF that does not open in the desired view.

Corrective Action – Ensure that PDF Opening settings are correct for all future submissions. The initial view of the PDF files should be set as Bookmarks and Pages in the Navigation Panel. If there are no bookmarks, the initial view should be set to Pages only. PDFs should open in ‘most recent view’ (i.e. ‘inherit zoom’ for bookmarks and links, and ‘default’ in open dialogue box).

Document has Password Protection

Problem – You have submitted a document that has password protection and cannot be opened. (Not applicable for FDA Forms)

Corrective Action – Resubmit the protected file in a later submission referencing the original leaf using the operation attribute of “Replace.”

Document has Annotations

Problem – You have submitted a document that has PDF annotations.

Corrective Action – Ensure that documents in future submissions do not have annotations.

Document Contains No Text

Problem – You have submitted a document that is a scanned image only and is not text searchable.

Corrective Action – Ensure that documents in future submissions are text searchable whenever possible (minimize the use of scanned documents).

Broken Bookmark

Problem – You have submitted a document with one or more bookmarks pointing to a file that does not exist.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have broken bookmarks.

Corrupt Bookmark

Problem – You have submitted a document with one or more bookmarks pointing to a file that cannot be opened.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have corrupt bookmarks.

Bookmark has Non-existent Named Destination or Page

Problem – You have submitted a document with one or more bookmarks pointing to a named destination or page that does not exist.

Correction Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have bookmarks linking to non-existent pages or named destinations.

Multiple Action Bookmark

Problem – You have submitted a document with one or more bookmarks containing multiple actions.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have bookmarks triggering multiple actions.

External Bookmark

Problem – You have submitted a document that makes reference to one or more external bookmarks (e.g. web links, email links).

Corrective Action – Ensure that documents in future submissions do not have bookmarks that are external to the application.

Inactive Bookmark

Problem – You have submitted a document that has one or more inactive bookmarks.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have inactive bookmarks.

Non-relative Bookmark

Problem – You have submitted a document that has one or more non-relative (absolute) bookmarks.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions have only relative bookmarks.

Bookmark does not ‘Inherit Zoom’

Problem – You have submitted a document with one or more bookmarks that are not set to ‘Inherit Zoom’.

Corrective Action – Ensure that all bookmarks are set to ‘Inherit Zoom’.

Broken Hyperlink

Problem – You have submitted a document with one or more hyperlinks pointing to a file that does not exist.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have broken hyperlinks.

Corrupt Link

Problem – You have submitted a document with one or more links pointing to a file that cannot be opened.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have corrupt links.

Link has non-existent Named Destination or Page

Problem – You have submitted a document with one or more hyperlinks pointing to a named destination or page that does not exist.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have links pointing to non-existent pages or named destinations.

Multiple Action Hyperlink

Problem – You have submitted a document with one or more hyperlinks containing multiple actions.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have links triggering multiple actions.

External Hyperlink

Problem – You have submitted a document that makes reference to one or more web references in a hyperlink (e.g. web links, email links).

Corrective Action – Ensure that documents in future submissions do not have hyperlinks that are external to the application.

Inactive Hyperlink

Problem – You have submitted a document that has one or more inactive hyperlinks.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have inactive hyperlinks.

Non-relative Hyperlink

Problem – You have submitted a document that has one or more non-relative (absolute) hyperlinks.

Corrective Action – Corrective action may be necessary and you will be contacted if it is necessary. Ensure that documents in future submissions do not have non-relative hyperlinks.

Link does not ‘Inherit Zoom’

Problem – You have submitted a document with one or more links that are not set to ‘Inherit Zoom’.

Corrective Action – Ensure that all links in future submissions are set to ‘Inherit Zoom’.

Author: Emily Onkka

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