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Tinjauan Critical Quality Attributes (CQA) dan Critical Process Parameter (CPP) Sebagai Bagian dari Pendekatan Quality by Design dalam Proses Pengembangan Tablet Salut Selaput Film
Abstrak
Quality by Design (QbD) merupakan suatu pendekatan sistematis untuk pengembangan produk yang dimulai dengan penetapan tujuan dan menekankan pemahaman produk, proses serta kontrol proses, berdasarkan ilmu pengetahuan dan manajemen risiko mutu. Terdapat beberapa elemen yang termasuk ke dalam QbD, diantaranya adalah Critical Quality Attributes (CQA) dan Critical Parameter Process (CPP). Sebagian besar bentuk sediaan tablet di pasaran merupakan tablet salut film. Sehingga, tujuan dari review ini adalah untuk mengetahui CQA dan CPP pada proses pengembangan tablet salut film. Dalam membuat review ini digunakan jurnal dan artikel hasil penelusuran di internet melalui website NCBI (dengan kategori yang dipilih adalah PubMed), science direct, dan google scholar yang sudah dipublikasi dalam 10 tahun terakhir. Dari hasil pencarian, didapatkan bahwa atribut mutu yang berpotensi untuk menjadi CQA dapat diidentifikasi dari setiap ruahan granul, inti tablet serta tablet salut. Selain itu, setiap tahapan proses dari mulai pengadukan, granulasi basah, pengayakan, pengeringan, pencetakan tablet, pencampuran larutan salut, serta penyalutan memiliki CPP yang perlu dipantau agar dapat dihasilkan produk yang sesuai dengan yang diharapkan.
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