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Literature Review : Analisis Komparatif Evolusi Validasi Proses serta Dampaknya dalam Industri Farmasi di Indonesia
Abstrak
Validasi proses dalam industri farmasi telah mengalami perkembangan signifikan dari pendekatan tradisional berbasis pembuktian batch menuju pendekatan lifecycle yang berbasis sains, data, dan manajemen risiko. Artikel ini bertujuan menganalisis evolusi pedoman validasi proses serta dampaknya terhadap industri farmasi di Indonesia melalui studi literature review dengan pendekatan deskriptif komparatif. Analisis dilakukan terhadap berbagai pedoman regulatori internasional dan nasional, meliputi US FDA, EU GMP, WHO TRS, PIC/S, ICH, dan CPOB. Aspek yang dibandingkan meliputi pendekatan validasi, jenis validasi, tahapan validasi proses, jumlah batch, penerapan Quality Risk Management (QRM), Quality by Design (QbD), continued/on-going process verification, penggunaan metode statistik, serta digitalisasi proses. Hasil kajian menunjukkan adanya harmonisasi global menuju pendekatan lifecycle validation yang menekankan pemantauan proses berkelanjutan, analisis statistik, dan pengendalian berbasis risiko sepanjang siklus hidup produk. CPOB menunjukkan arah harmonisasi dengan pedoman internasional melalui pendekatan hibrida yang mengintegrasikan konsep tradisional dan lifecycle. Namun, implementasi validasi proses modern di Indonesia masih menghadapi tantangan berupa keterbatasan teknologi, investasi, infrastruktur digital, serta kompetensi sumber daya manusia. Selain itu, industri farmasi Indonesia dituntut memenuhi standar regulator internasional untuk meningkatkan daya saing dan akses pasar global. Oleh karena itu, penguatan sistem mutu, pengembangan kompetensi, harmonisasi regulasi, serta percepatan digitalisasi menjadi faktor penting dalam mendukung implementasi lifecycle process validation di industri farmasi Indonesia.
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