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Studi Kapabilitas Proses Ampul Asam Traneksamat 100 mg pada Suatu Industri Farmasi di Jawa Barat
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Industri farmasi memegang penuh tanggung jawab terhadap mutu dari produk yang dihasilkannya. Mutu produk harus dijaga sejak awal hingga akhir proses produksi sehingga konsumen mendapatkan produk yang aman, efektif, dan sesuai khasiatnya. Untuk meninjau suatu proses produksi dapat konsisten menghasilkan produk yang memenuhi spesifikasi, dilakukan Product Quality Review (PQR) dengan melihat indeks kapabilitas (Cpk). Penelitian ini bertujuan untuk mengetahui pengendalian mutu dari sediaan ampul asam traneksamat 100 mg pada industri farmasi di Jawa Barat dengan menganalisis kapabilitas proses serta menggali upaya peningkatan kualitas dengan metode six sigma melalui 5 tahapan analisa DMAIC (Define, Measure, Analyze, Improve, dan Control). Hasil penelitian menunjukkan nilai Cpk < 1,33. Hal ini menandakan bahwa indeks kapabilitas proses masih belum memadai, dan didapatkan variasi mutu pada proses masih lebar. Rekomendasi yang dapat dilakukan dalam meningkatkan mutu proses diantaranya meningkatkan kemampuan personil dengan pelatihan, serta meninjau kembali metode yang digunakan pada tahap analisis kadar dan produksi.
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