Artikel Review : Perencanaan Pola Pengambilan Sampel Produk Antara pada Validasi Proses
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Industri farmasi harus dapat memastikan mutu suatu bets dalam proses produksi melalui validasi sepanjang proses produk. Maka dari itu, perlu dilakukan validasi proses untuk memastikan bahwa setiap parameter dan prosedur yang digunakan dalam setiap proses memproduksi produk antara memperoleh hasil yang memenuhi mutu dan spesifikasi yang dipersyaratkan. Pengambilan sampel merupakan salah satu pedoman dalam melakukan validasi proses, sehingga perlu dilakukan perencanaan untuk menentukan titik lokasi pengambilan yang didasarkan pada risiko dan alasan ilmiah. Review ini bertujuan untuk memberikan informasi terkait alat-alat yang digunakan untuk pengambilan sampel, jumlah titik pengambilan sampel pada sediaan padat, semi padat dan non-steril cair. Diharapkan review ini dapat menjadi pertimbangan untuk Industri Farmasi dalam perencaan pengambilan sampel produk antara pada validasi proses. Metode yang dilakukan yaitu penelusuran pustaka dari database yang tersedia secara online dari ScienceDirect dan standar dari lembaga otoritas. Hasil yang didapat pada review ini yaitu alat yang dapat digunakan dalam pola pengambil sampel untuk sediaan padat yaitu thief sampler, simple bag-sampling spears, dan scoop dan untuk sediaan non-steril cair dan semi padat yaitu dip tubes dan weighted container. Pada pola pengambilan sampel saat proses pencampuran sediaan padat, terdapat 10 titik pengambilan. Sedangkan pada pola pengambilan sampel saat proses pencampuran sediaan non-steril cair dan semi padat, terdapat 9 titik pengambilan. Dengan validasi ini, maka dapat merespresentatifkan konsistensi mutu produk.
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