# Skills tagged "Pharmaceutical"

4 skills with this tag.

URL: https://rakenne.app/skill-tags/pharmaceutical/index.md

- [Annex 1 CCS Validator](https://rakenne.app/skills/annex1-ccs-validator/index.md) — Draft and validate a Contamination Control Strategy (CCS) for pharmaceutical sterile manufacturing per EU GMP Annex 1 (2023). Maps cleanroom classifications to grades A/B/C/D, validates environmental …
- [Biotech Dossier Expert — Terapias Avançadas (ANVISA)](https://rakenne.app/skills/biotech-dossier-expert/index.md) — Elaboração do dossiê técnico para registro de produtos de terapias avançadas (células, tecidos, terapias gênicas). Organiza documentação de CQ, esterilidade e dados clínicos conforme RDC 338/2020 e …
- [eCTD Cross-Module Verifier](https://rakenne.app/skills/ectd-cross-module-verifier/index.md) — Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, …
- [GMP SOP & Validation Author](https://rakenne.app/skills/gmp-sop-validation-author/index.md) — Guided elaboration of GMP documentation — SOPs, validation protocol (IQ/OQ/PQ), and batch record template sections aligned to FDA 21 CFR 211 / EU EudraLex Vol 4 / WHO GMP.

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