# Skills tagged "GMP"

3 skills with this tag.

URL: https://rakenne.app/skill-tags/gmp/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 …
- [Dossiê CBPF — GMP Document Factory](https://rakenne.app/skills/gmp-document-factory/index.md) — Preparação para inspeções de certificação de plantas fabris (CBPF). Gera POPs e registros de treinamento; valida o Plano Mestre de Validação quanto à qualificação de equipamentos térmicos e …
- [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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