e CTD PDF Preparation #1
Description
duttain-create
Issue body actions
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| Module 1: | Cover Letters, application forms, labelling | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Module 2: | Overview and Summaries (QOS) | |||||||||
| Module 3: | Drug Substance, Drug Product, Stability | |||||||||
| Granularity: | ||||||||||
| Granularity is about how break dossier content into separate documents (pdfs) within each section | ||||||||||
| Node: | ||||||||||
| Node represents in Ectd section or sub section (e.g 3.2,3.2.S.1) | ||||||||||
| Folder in a dossier | ||||||||||
| Leaf | ||||||||||
| A leaf is the actual file (PDF) LINKED TO A Node | ||||||||||
| Leaf node: | The node where actual file (PDF) is attached | |||||||||
| Node: folder in a dossier | Leaf:document inside the folder | |||||||||
| 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 | ||||||||||
| 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 | ||||||||||
| Naming Conventions: Adhere to specific alphanumeric naming rules (usually lowercase, no spaces) required by the regional regulatory authority. | ||||||||||
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