Review Artikel: Critical Quality Attributes dan Critical Process Parameter dari Tablet Kempa Langsung

Gabriella Joan Caren

Abstrak


Quality by Design (QbD) merupakan pendekatan sistematis yang dapat mengidentifikasi karakteristik yang sangat penting untuk kualitas produk obat. Salah satu elemen kunci dari QbD antara lain Critical Quality Attribute (CQA) dan Critical Process Parameter (CPP), dimana CPP dapat mempengaruhi CQA produk obat. Tablet merupakan sediaan farmasi yang banyak digunakan oleh masyarakat, dimana salah satu jenisnya adalah tablet kempa langsung. Oleh karena itu tujuan dari review artikel ini adalah untuk mengetahui CQA produk dan CPP proses produksi obat tablet kempa langsung. Metode yang dilakukan adalah pencarian data primer dengan instrumen pencari secara online dan manual pada pustaka yang relevan. Dari hasil review artikel, didapat bahwa penting untuk mengetahui CQA dari campuran akhir (hasil tahap pencampuran akhir) dan tablet jadi (hasil pencetakan). Baik pada tahap pencampuran akhir dan pencetakan pun memiliki CPP masing-masing yang perlu dipantau karena dapat berdampak terhadap CQA produk.

Kata kunci: quality by design, CQA, CPP, tablet


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DOI: https://doi.org/10.24198/farmaka.v21i2.46808

DOI (PDF): https://doi.org/10.24198/farmaka.v21i2.46808.g20630

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