WHOPQT Validation 1.1 (Full) WHOPQT 1.1 en Full WHOPQT Validation Criteria v1.1 with additional recommended criteria. The specified filename is used for the WHO-PQT M1 DTD 6.17.57 The file is placed in the correct folder for the WHO-PQT M1 DTD 6.17.57 A currently acceptable version of the WHO-PQT M1 DTD is used (checksum matches the published value) 6.17.47 The version number of the WHO-PQT M1 DTD used in the sequence being tested is higher than or equal to the version of the DTD used in the sequence numerically preceding the incoming sequence in the eCTD lifecycle. 6.17.66 The version number of the WHO-PQT M1 DTD used in the sequence being tested is lower than or equal to the version of the DTD used in the sequence numerically succeeding the incoming sequence in the eCTD lifecycle. 6.17.81 The specified filename is used for the WHO-PQT M1 leaf MOD file 6.17.57 The file WHO-PQT M1 leaf MOD file is placed in the correct folder 6.17.57 The checksum for the whopqt-leaf.mod file used must match the published checksum for the who-leaf.mod file associated with the DTD used for the sequence 6.17.47 The specified filename is used for the WHO-PQT M1 envelope MOD file 6.17.57 The WHO-PQT M1 envelope MOD file is placed in the correct folder 6.17.57 The checksum for the whopqt-envelope.mod file used must match the published checksum for the whopqt-envelope.mod file associated with the DTD used for the sequence 6.17.47 The specified filename for the ICH DTD is used 6.17.57 The ICH DTD file is placed in the correct folder 6.17.57 A currently acceptable version of the ICH DTD is used (checksum matches the published value) 6.17.46 The version number of the ICH DTD used in the sequence being tested is higher than or equal to the version of the DTD used in the sequence numerically preceding the incoming sequence in the eCTD lifecycle. 6.17.65 The version number of the ICH DTD used in the sequence being tested is lower than or equal to the version of the DTD used in the sequence numerically succeeding the incoming sequence in the eCTD lifecycle. 6.17.80 The Index MD5 file is placed in the correct folder 6.17.53 The file Index MD5 file is named correctly 6.17.54 The regenerated checksum for the index.xml matches the value in the file index-md5.txt. 6.17.5 The index.xml is placed in the correct folder 6.17.39 The index.xml file is named correctly 6.17.56 The index.xml file is well formed 6.17.48 The index.xml file is valid 6.17.48 The reference to the DTD in index.xml is directed to the DTD provided in the util folder. 6.17.52 The whopqt-regional.xml file is placed in the correct folder 6.17.39 The whopqt-regional.xml file is named correctly 6.17.56 The whopqt-regional.xml file is well formed 6.17.48 The whopqt-regional.xml file is valid 6.17.48 The reference to the DTD in whopqt-regional.xml is directed to the DTD within the util-folder. 6.17.52 The leaf attribute 'checksum-type' has a value of md5 or MD5 6.17.2 The regenerated checksum for each file matches the value in the leaf attribute 'checksum' 6.17.7 For every leaf the 'title' attribute is not empty 6.17.25 All leaves with an operation attribute value of new, replace or append must have a value for the cross reference (xlink:href) 6.17.27 All leaves with an operation attribute value of delete must have no value for the cross reference (xlink:href) 6.17.26 The file referenced by the cross reference (xlink:href) must exist in the same or a previously submitted sequence within the same eCTD application 6.17.28 All leaves with an operation attribute value of replace, delete or append must have a value for modified-file 6.17.13 All leaves with an operation attribute value of new must have no value for modified-file 6.17.42 The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application. 6.17.14 For all leaves (except leaves within node extensions and leaves in module 3.2.A) with an operation attribute value of replace, delete or append, the modified file must be present in the same CTD section of the dossier. Note: Using the operation attribute 'delete' to remove content placed in m1-additional-data is exempt from this rule. 6.17.82 Two leaf elements should not have the same leaf ID. 6.17.298 For all leaves with an operation attribute value of replace, delete or append the modified file must not have been replaced or deleted by any other leaf element in any sequence including the current one. 6.17.299 For all leaves within node extensions or module 3.2.A with an operation attribute value of replace, delete or append, the modified file should be present in the same node extension or attribute-defined section. 6.17.265 ICH attributes must not contain leading or trailing spaces, nor start or end with hyphens. 6.17.297 No PDF has been created and saved as version 1.3 or earlier 6.17.18 There is no security setting to open any individual file 6.17.40 There are no further security settings applied to any individual file (except for files in Modules 1.0, 1.2.1, 3.3, 4.3 and 5.4) 6.17.40 Individual files in section 1.0 and 1.2.1 have no security settings except for the following: Changing the document Document assembly Page extraction Commenting Creation of template pages. 6.17.70 The submission does not contain corrupted files 6.17.43 Files have been created and saved as PDF 1.4, 1.5, 1.6, or PDF 1.7 6.17.18 Hyperlinks and bookmarks within documents, or between documents within the same sequence, have a valid target. 6.17.17 Hyperlinks and bookmarks to destinations in a different sequence in the same eCTD dossier have a valid target. 6.17.17 All hyperlinks and bookmarks are set to 'inherit zoom' 6.17.63 PDFs except the files from section 1.0 and 1.2.1 must have 'Fast Web View' active 6.17.16 PDF Document Properties for the Initial View are set for 'Page Layout = Default' and 'Magnification = Default' 6.17.12 All PDF hyperlinks and bookmarks are relative 6.17.15 The bookmarks pane should be visible if bookmarks are included within a PDF document 6.17.10 The bookmarks pane should not be visible if there are no bookmarks included within a PDF document 6.17.11 All hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008 6.17.67 The UUID is well formed according to ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005 6.17.239 The UUID of a sequence must be identical to the one in the previous sequence. 6.17.240 If the submission unit type is ‘initial’ or ‘reformat' then the related-sequence attribute must have a value equal to the current sequence. 6.17.247 If the submission unit type is not equal to ‘initial’ or ‘reformat' then the entry for related sequence must not be equal to the value for the current sequence. 6.17.74 Envelope Attributes: data is provided for all mandatory envelope fields and should be in the correct format, according to the requirements of FPP, FVP, APIPQ or APIMF. 6.17.416 The sequence folder name is a 4 digit number 6.17.30 The sequence number (folder name) has not already been used 6.17.32 The sequence folder name matches the sequence number in the WHOPTQ envelope in whopqt-regional.xml 6.17.31 All the lowest level heading elements in the XML (including node-extensions) included in the submission contain at least one leaf 6.17.19 Mandatory Files are provided: cover letter (mandatory for all application types) 6.17.417 For submission unit type 'initial' and 'reformat' all required documents for the submitted application type are provided. 6.17.418 APIMF: 2.3.S and 3.2.S: file names for specific sections should contain the correct prefix 6.17.419 APIMF: 3.2.S: folder names for specific sections should contain the correct prefix 6.17.420 APIMF: 2.3.S and 3.2.S attributes of specific sections should contain op or rp as prefix 6.17.421 The files provided in the folders for Module 1 are in acceptable formats 6.17.44 6.17.45 The files provided in the folders for Module 2-5 are in acceptable formats 6.17.44 6.17.45 Total file folder path length must not exceed 180 characters 6.17.35 6.17.36 File names, including the extension, must not exceed 64 characters 6.17.33 Folder names must not exceed 64 characters 6.17.33 Only valid characters are used in file names 6.17.34 Only valid characters are used in folder names 6.17.34 There are no unreferenced files in M1, M2, M3, M4 and M5 folders 6.17.37 The only files in the sequence folder (/XXXX/…) are the index.xml and index-md5.txt 6.17.37 There are no empty folders 6.17.62 Individual files do not exceed 500 MB in size 6.17.21 6.17.22 The recommended folder structure and folder names in the ICH eCTD Specification and WHOPQT Module 1 eCTD Specification are used 6.17.49 The recommended file names from the ICH eCTD Specification and WHOPQT Module 1 eCTD Specification are used for all files. 6.17.49 The Application Type attribute value is valid . 6.17.165 The Application Sub Type attribute value is valid. 6.17.422 The Product Type attribute value is valid. 6.17.311 The Product Sub Type attribute value is valid. 6.17.423 The Submission Unit Type attribute value is valid. 6.17.424 Only specified combination for Product type, Application type and Application sub-type are valid. 6.17.425 Only specified combinations of Application type and Submission Unit type are valid for the first eCTD formatted submission for a product. 6.17.426 The overall validation result should not exceed 50 best practice notifications. 6.17.427 Node Extensions in M1 should only be represented in the XML backbone, no additional directory should be created 6.17.428 For every node-extension the 'title' attribute is not empty 6.17.25 Ensure that 'checksum' attribute is present and value for the attribute is provided (i.e. not empty string) when 'operation' attribute for the leaf(s) is 'new', 'append' or 'replace' 6.17.3 Ensure that 'checksum' attribute value is not provided when 'operation' attribute for the leaf(s) is 'delete' 6.17.4 Ensure that invalid formatting is not provided for 'checksum' in index-md5.txt (32 characters are not specified for the MD5 checksum, or included trailing spaces or carriage returns) 6.17.6 Ensure that all files must have one and only one file extension 6.17.9 Ensure there is no reference leaf(s) point to a file (outside of the eCTD lifecycle) across application (xlink:href points to a different application) 6.17.24 Ensure that the xlink:href and/or modified-file attribute conforms to the eCTD standard (valid characters - no backslash '\', colon':', asterisk'*', question mark'?', less than'<', greater than'>', pipe' | ', or space ' ', file path relative to the backbone xml files and includes file name in the path) 6.17.29 Ensure that 'util' folder exists and is in the correct location (<sequence number>/util) 6.17.38 Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version 6.17.41 Ensure that all files and folders in the submission are accessible to the user. 6.17.64 Ensure that the hyperlinks and/or bookmarks in the submission documents does not target document outside current eCTD application 6.17.69 Provide list of all documents in the submission containing annotation (other than links and bookmarks) 6.17.83 Ensure that all pdf documents in the submission must not have any attachments 6.17.84 Ensure that all hyperlinks and bookmarks in the submission documents must not have multiple actions (e.g. opening two different pages) 6.17.85 Ensure that all hyperlinks and bookmarks (internal, external, same sequence, across sequences and across applications) in the submission documents are not inactive (without any action) 6.17.86 Ensure that all hyperlinks and bookmarks in the submission documents must not have unknown action (links that could not be identified or contain JavaScript code) and print total count 6.17.87 Ensure that all hyperlinks and bookmarks in the submission documents must not point to external destinations (other than web or email) 6.17.88 Ensure that all hyperlinks and bookmarks in the submission documents must not point to web address or email 6.17.89 Print the count of all of the hyperlinks and the bookmarks with following criteria: - Non-Relative Hyperlinks - Non-Relative Bookmarks - Web link and email hyperlinks - Web links and email bookmarks - External Hyperlinks (excluding web links and emails) - External Bookmarks (excluding web links and emails) - Unknown Action Hyperlinks - Unknown Action Bookmarks - Inactive Hyperlinks - Inactive Bookmarks - Broken Hyperlinks (separate count for inter-application, intra-application and intra-sequence) - Broken Bookmarks (separate count for inter-application, intra-application and intra-sequence) - Number of bookmarks per document - Total number of bookmarks in the submission - Number of hyperlinks per document - Total number of hyperlinks in the submission 6.17.90 Ensure that the link and/or bookmark destination does not point to a corrupt document 6.17.91 Ensure that the links and/or bookmark in the submission documents point to an existing page and/or named destinations. 6.17.92 Ensure that all documents in the submission are text searchable 6.17.93 Ensure that fonts referenced by the PDF documents in the submission are standard fonts and all non-standard fonts are fully embedded 6.17.102 Ensure that 'title' element of the 'leaf' and/or 'node-extension' does not begins or ends with a space. The system shall include in the message name/title of the node extension where title begins or ends with space. 6.17.167 Ensure that valid/supported 'dtd-version' is referenced in the ICH and regional backbone xml files. 6.17.170 Ensure that 'dtd-version' is referenced in the ICH and regional backbone xml files. 6.17.173 Ensure that required attributes (e.g. 'indication' in the section 5.3.5 element or 'type of control' in the STF XML file for a study in section 5.3.5.1) are present in the back bone xmls (index and regional) and in the heading element of STF XML file(s). 6.17.176 Ensure that attribute (i.e. substance, company-name, species) values in ICH, regional and/or STF backbone files does not begins or ends with a space. The system shall include in the message attribute and value that begins or ends with space. 6.17.177 Ensure that non-required files are not present in the util folder (i.e. submission does not have an stf or leaf but the stylesheet and dtd files are present in the util folder) 6.17.178 Ensure that operation attribute is present and valid value ('new', 'append', 'replace' or 'delete') for the attribute is provided. The system shall include in the message the name of the file where operation attribute is not present and/or valid value is not provided. 6.17.180 Ensure that 'operation' attributes for cover letter and application form leaf must be 'new' 6.17.181 Ensure that 'append' operation is not applied on an existing lifecycle 'append' leaf (E.g. Detect invalid life cycle pattern: sequence 0001 appends a document in sequence 0000, sequence 0002 append operation leads to the append in 0001.) 6.17.199 Ensure that leaf lifecycle operation ('append', 'replace' or 'delete') is not applied to a lifecycle 'delete' leaf (E.g. sequence 0001 deletes a document in sequence 0000, sequence 0002 any life cycle operation leads to the already deleted leaf in 0001.) 6.17.200 Ensure that a leaf is not lifecycled ('append', 'replace' or 'delete') by more than one leaf to cause branching (i.e. scenario where a append/replace/delete operation is being applied on a leaf, which has already been replaced by another leaf. E.g. sequence 0001 replaces a document in sequence 0000, sequence 0002 append operation leads to the already replaced leaf in 0000.) 6.17.201 Ensure same xlink:href is not referenced more than once in the backbone xml files 6.17.202 Ensure that all element in the submission backbone xml files must have leaf child nodes 6.17.204 Ensure that xlink:href attribute in backbone xml files does not point to leaf outside current sequence 6.17.205 Ensure that 'xlink:href' attribute in backbone xml files does not point to leaf outside application 6.17.206 Ensure that only operation 'new' is used for all leafs in the initial sequence of the application 6.17.207 Ensure multiple lifecycle operations on same document in same sequence are not allowed (E.g. sequence 0001 includes two lifecylce operations referencing the same leaf in sequence 0000.) 6.17.209 Ensure attribute (if present i.e. indication, excipient, dosage-form, manufacturer, product-name, substance etc.) value must not be empty string 6.17.212 Ensure that the initial sequence of the application must be '0000' 6.17.213 Ensure that the sequence being validated is the highest sequence in the application 6.17.217 Ensure that the reference for the regional xml backbone file in index.xml must have operation attribute value 'new' 6.17.219 Ensure that 'm1' folder must exist in the submission 6.17.220 Ensure that the sequence numbers in an application are increased incrementally (The sequence number related to the life cycle should increase incrementally with each subsequent submission, for example 0000, 0001, 0002 etc. (the increase should occur in chronological order) 6.17.238 Ensure PDF documents with more than 10 pages must have bookmarks 6.17.281 Ensure to find all documents where copying the content is not allowed. 6.17.296 Ensure that PDF documents in the submission do not include JavaScript, 3D contents or dynamic contents (audio/video) 6.17.305