Model Rapid Application Development RAD Pengembangan Evolusioner

2. Analyst mencatat semua data pengujian dalam formulir record of analysis dan melampirkan kromatogram yang diperoleh selama proses validasi 3. Analyst memasukkan semua data pengujian ke formulir data of method developmentvalidation with internal standard lalu melaporkannya pada analytical supervisor. 4. Analytical supervisor melakukan perhitungan statistik dan membandingkannya terhadap kriteria penerimaan tiap parameter. 5. Analytical supervisor lalu memindahkannya ke dalam formulir report of analytical method validation with internal standard lalu melaporkannya kepada technical manager. 6. Setelah diperiksa dan disahkan oleh technical manager report of analytical method validation with internal standard lalu di periksa dan disahkan oleh QA manager. Flowmap sistem validasi tersebut dapat dilihat pada gambar III.1. Analytical Supervisor Analyst Keterangan : A1 : Record of analysis A2 : Kromatogram A3 : Data of method developmentvalidation with internal standard A4 : Report of analytical method validation with internal standard Technical Manager QA Manager Formulir analytical method validation programme Formulir analytical method validation programme Validasi metode Kromatogram Record of analysis Pengisian data Perhitungan data Report analytical method validation with internal standard Pemeriksaan dan pengesahan Pemeriksaan dan pengesahan Memenuhi syarat? Y A4 Memenuhi syarat? A2 A1 A3 Kromatogram Record of analysis Data of method development validation with internal standard Kromatogram Record of analysis Data of method development validation with internal standard Kromatogram Record of analysis Data of method development validation with internal standard Report analytical method validation with internal standard Kromatogram Record of analysis Data of method development validation with internal standard Report analytical method validation with internal standard Kromatogram Record of analysis Data of method development validation with internal standard Report analytical method validation with internal standard Kromatogram Record of analysis Data of method development validation with internal standard Report analytical method validation with internal standard Kromatogram Record of analysis Data of method development validation with internal standard Y T T Gambar III.1 Flowmap validasi metode analisis uji bioequivalensi