ARTICLE REVIEW: PARAMETER DAN PENDEKATAN BERBASIS RISIKO TERKAIT VALIDASI PEMBERSIHAN DI INDUSTRI FARMASI

Veronika Ellena, Dolih Gozali

Abstrak


Validasi pembersihan merupakan suatu pembuktian yang terdokumentasi terkait proses pembersihan alat atau mesin di industri farmasi. Validasi prosedur pembersihan merupakan hal yang sangat penting dalam industri farmasi untuk mendapatkan informasi terkait konsistensi dan efisiensi metode pembersihan dalam peralatan di industri farmasi. Validasi pembersihan berbasis risiko bertujuan untuk meningkatkan mutu dan keamanan produk dengan memvalidasi metode pembersihan secara efektif dan juga membantu dalam meningkatkan kesiagaan untuk mengatasi risiko. Artikel ini membahas tentang berbagai parameter pada validasi pembersihan serta validasi pembersihan berdasarkan pendekatan berbasis risiko.


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Referensi


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DOI: https://doi.org/10.24198/farmaka.v21i2.40454

DOI (PDF): https://doi.org/10.24198/farmaka.v21i2.40454.g20623

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