Temiz Oda Paspas Dokümantasyonu — GMP Denetimine Hazırlık Kontrol Listesi
A practical 20-item checklist to prepare cleanroom mop documentation for FDA, MHRA, and GMP audits. Covers COA, Certificate of Irradiation, particle test reports, batch traceability, and change control records that auditors expect to see. Free downloadable checklist available.
Temiz Oda Paspas Saklama ve Kullanma Kılavuzu — Preventing Cross-Contamination in GMP Facilities
How cleanroom mops should be stored, dried, and handled between uses to prevent cross-contamination in GMP facilities. A practical guide covering drying validation, container selection, FIFO rotation, storage room environmental requirements, and an audit-ready storage checklist.
Temiz Oda Paspas Dökülmesine Müdahale - GMP Tesisleri için Protokol ve Araç Kullanma Kılavuzu
Spill response in a cleanroom is a distinct cleaning event from routine mopping — it requires faster response, containment before cleaning, dedicated spill kit tooling (separate from routine cleaning mops), additional documentation (spill incident report linked to cleaning records), and specific operator training. A facility that treats spills as “just clean it up” has an undocumented gap in its contamination control program. This protocol and tooling guide provides a step-by-step framework that GMP facilities can implement directly, including a spill kit contents specification and a spill incident report template.
