e CTD PDF Preparation

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Module 1: | Cover Letters, application forms, labelling |   |   |   |   |   |   |   |   |  
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Module 2: | Overview and Summaries (QOS) |   |   |   |   |   |   |   |   |   |  
Module 3: | Drug Substance, Drug Product, Stability |   |   |   |   |   |   |   |   |  
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Granularity: |   |   |   |   |   |   |   |   |   |   |   |  
Granularity is about how break dossier content into separate documents (pdfs) within each section |   |   |   |   |  
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Node: |   |   |   |   |   |   |   |   |   |   |   |   |  
Node represents in Ectd section or sub section (e.g 3.2,3.2.S.1) |   |   |   |   |   |   |   |  
Folder in a dossier |   |   |   |   |   |   |   |   |   |   |   |  
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Leaf |   |   |   |   |   |   |   |   |   |   |   |   |  
A leaf is the actual file (PDF) LINKED TO A Node |   |   |   |   |   |   |   |   |  
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Leaf node: | The node where actual file (PDF) is attached |   |   |   |   |   |   |   |   |  
Node: folder in a dossier | Leaf:document inside the folder |   |   |   |   |   |   |   |  
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Important Notes |   |   |   |   |   |   |   |   |   |   |   |  
PDF Specifications |   |   |   |   |   |   |   |   |   |   |   |  
PDF Version shall be 1.4-1.7 | EMA :Version 6.0.1 effective from March 2025 |   |   |   |   |   |  
below this range e CTD Validation not support |   |   |   |   |   |   |   |   |  
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Page Size: FOR US : 8.5 inches by 11 inches |   |   |   |   |   |   |   |   |   |  
for Europe : A4 size8.26 inches x 11.69 inches | Letter size |   |   |   |   |   |   |   |   |  
PDF optimised for fast overview and lesser time download)means view zoom % must be uniform |   |   |   |   |  
Bookmarks to navigate | (mandatory for documents >5 pages |   |   |   |   |   |   |   |  
Hyperlink to navigate    (two types with rectangular for same document and without rectangular for external link that is not allowed) |   |  
Internal Hyperlinks only |   |   |   |   |   |   |   |   |   |   |  
PDF Shall be searchable (OCR) |   |   |   |   |   |   |   |   |   |   |  
OCR to be run |   |   |   |   |   |   |   |   |   |   |   |  
Images to be OCR enable |   |   |   |   |   |   |   |   |   |   |  
Fonts embeded | go to file then properties then fonts see embedded means another computer see the same formating |   |   |  
File Size:Keep each PDF <100MB |   |   |   |   |   |   |   |   |   |   |  
FONT SIZE 12 and TIMES NEW ROMAN | Font size not exceeds 100 MB(FDA) |   |   |   |   |   |  
Header /footers with title & sequence |   |   |   |   |   |   |   |   |   |  
Resolution less than 600 dp |   |   |   |   |   |   |   |   |   |   |  
Black and white preffered for text and color permitted for figures /graphics |   |   |   |   |   |   |  
Table of content | Required for documents.5 pages must TOC |   |   |   |   |   |   |   |  
Fonts size limits less than,100MB |   |   |   |   |   |   |   |   |   |   |  
No security that is PDF shall not password protected |   |   |   |   |   |   |   |   |  
Lossless compression: ZIP or CCITT Group 4 for images (sccaned clinical chart compressed with CCIT Group 4 memains identical to original |   |  
Go to file then properties then drescription look image compression if it is zip or CCIT Group 4 that’s lossles or if it is JPEG that’s lossy not acceptable |  
Life cycle Management: Replace,ammend and delete |   |   |   |   |   |   |   |   |  
Maintain version control -track sequence number and documents update |   |   |   |   |   |   |  
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Naming Conventions: Adhere to specific alphanumeric naming rules (usually lowercase, no spaces) required by the regional regulatory authority.
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