Gap Analysis Sistem Pengendalian Perubahan (Change Control) pada Industri Farmasi X di Bandung Jawa Barat: Upaya Penguatan Sistem Mutu CPOB 2024 dan ICH Q7A

Yuni Nurjanah; Dolih Gozali

doi:10.59945/jpnm.v4i3.1523

Authors

Yuni Nurjanah Universitas Padjadjaran
Dolih Gozali Universitas Padjadjaran

DOI:

https://doi.org/10.59945/jpnm.v4i3.1523

Keywords:

CPOB, Gap Analysis, ICH Q7A, Pengendalian Perubahan, Sistem Mutu Industri Farmasi

Abstract

Pengendalian perubahan (change control) merupakan elemen kritis dalam Sistem Mutu Industri Farmasi yang bertujuan menjamin konsistensi mutu produk sepanjang siklus hidupnya. Penelitian ini bertujuan menganalisis kesenjangan (gap analysis) implementasi sistem pengendalian perubahan pada Industri Farmasi X di Bandung, Jawa Barat, terhadap persyaratan Cara Pembuatan Obat yang Baik (CPOB) Bab 12 dan International Conference on Harmonisation (ICH) Q7A Bab 13. Metode penelitian menggunakan pendekatan deskriptif evaluatif dengan membandingkan prosedur tetap (Protap) dan praktik aktual departemen Quality Assurance (QA) terhadap 14 butir persyaratan yang bersumber dari CPOB (butir 12.96–12.102) dan ICH Q7A (butir 13.10–13.17). Data dikumpulkan melalui telaah dokumen Prosedur Tetap Pengendalian Perubahan, formulir usulan perubahan, serta observasi pelaksanaan di lapangan. Hasil analisis menunjukkan bahwa seluruh 14 butir persyaratan dinyatakan "Sesuai," mencakup aspek integrasi pengendalian perubahan dalam sistem mutu, ketersediaan prosedur tertulis, evaluasi dampak berbasis manajemen risiko mutu menggunakan Failure Mode Effect Analysis (FMEA), otorisasi berjenjang, kajian data pendukung, evaluasi efektivitas pasca-implementasi, klasifikasi risiko berdasarkan Risk Priority Number (RPN), revisi dokumen terdampak, evaluasi bets pertama, serta pemantauan stabilitas. Meskipun demikian, perbaikan berkelanjutan tetap diperlukan pada aspek optimalisasi objektivitas penilaian risiko dan pengembangan design space. Melalui penelitian ini, diharapkan dapat digunakan sebagai referensi terkait evaluasi kesesuaian sistem pengendalian perubahan di industri farmasi Indonesia.

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