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Analisis Komparatif Parameter Product Quality Review Berdasarkan Regulasi Nasional dan Internasional serta Kaitannya dengan Pharmaceutical Quality System
Abstrak
Product Quality Review (PQR) merupakan komponen penting dalam Pharmaceutical Quality System (PQS) yang berfungsi untuk memastikan konsistensi proses, mutu produk, dan peningkatan berkelanjutan sepanjang siklus hidup produk. Penelitian ini bertujuan untuk menganalisis dan membandingkan parameter PQR berdasarkan regulasi nasional, yaitu Cara Pembuatan Obat yang Baik (CPOB) edisi 2024, dengan berbagai pedoman internasional, meliputi European Union Good Manufacturing Practice (EU GMP), Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice (PIC/S GMP), World Health Organization Technical Report Series No. 986 Annex 2, serta regulasi United States Food and Drug Administration (US FDA) dalam 21 CFR Part 211.180. Penelitian dilakukan menggunakan metode analisis dokumen dengan pendekatan komparatif terhadap parameter PQR yang tercantum pada masing-masing pedoman. Hasil analisis menunjukkan adanya tingkat keselarasan yang tinggi pada parameter utama, seperti evaluasi bahan awal dan bahan pengemas, pengawasan selama-proses, hasil pengujian produk jadi, deviasi, Corrective and Preventive Action (CAPA), serta keluhan dan penarikan produk. Perbedaan utama terletak pada cakupan evaluasi dan pendekatan regulatori, di mana CPOB, EU GMP, PIC/S GMP, dan WHO cenderung lebih preskriptif, sedangkan US FDA menerapkan pendekatan berbasis prinsip yang lebih fleksibel. Pembahasan lebih lanjut menunjukkan bahwa PQR tidak hanya berfungsi sebagai alat evaluasi tahunan, tetapi juga berperan dalam Quality Risk Management, analisis tren mutu, pengelolaan siklus hidup produk, penerapan integritas data, serta mendukung implementasi PQS berdasarkan ICH Q10. Perkembangan teknologi digital diperkirakan akan mentransformasi PQR melalui pemanfaatan artificial intelligence, predictive quality, Digital Twin, Continuous Process Verification, dan Real-Time Release Testing. Kajian ini menegaskan pentingnya harmonisasi parameter PQR sebagai dasar penguatan sistem mutu farmasi yang adaptif, berbasis risiko, dan mampu memenuhi tuntutan regulasi global.
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