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Kajian Risiko Proses Penyediaan Produk Semisolid Industri X di Cikarang Selatan
Abstrak
Keselamatan pengguna adalah fokus utama industri farmasi dalam pembuatan sebuah produk yang bermutu dan terjaga keamanannya. Selama proses penyiapan produk tersebut, tentu tidak akan terlepas dari risiko kegagalan ataupun potensi berbahaya yang tidak dapat diketahui sebelumnya. Kajian risiko sudah menjadi program mandatori secara global, dengan regulasi yang bersumber pada ICH Q9 tentang Quality Risk Management dan di Indonesia sendiri diatur di Aneks ke - XIII tentang Manajemen Risiko Mutu. Tujuan penyusunan artikel ini adalah untuk mendapatkan langkah sistematis dalam mengelola risiko-risiko yang mungkin terjadi agar dapat dicegah dan diminimalisir dengan menggunakan kajian risiko. Metode yang digunakan dalam penelitian ini adalah wawancara dan diskusi di industri terkait. Hasil dari pengkajian risiko, dapat diketahui bahwa terdapat 2 proses dengan risiko yang tinggi pada produk yaitu proses pencampuran dan pengisian. Sehingga dapat disimpulkan bahwa kedua risiko tersebut menjadi prioritas dalam penanganannya dan perlu dimonitoring secara berkelanjutan. Selain itu terdapat risiko dengan nilai probabilitas(P) x severitas(S) tertinggi yaitu risiko kontaminasi pada proses pencampuran. Dengan adanya kajian risiko,diharapkan industri farmasi mampu mendeteksi lebih awal terkait risiko yang mungkin muncul dan mampu meminimalisir segala kerugian yang mungkin terjadi.
Kata kunci: risiko, kajian risiko, kontaminasi
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