Batch Size

DES20C

Kode Bahan Nama Bahan Manufacturer Expired Date Jumlah per Jumlah per
unit dosis batch
A1020C Loperamid Hetero Drug 30/11/2025 2 mg 2 mg x
HCl Limited 100.000
T09 Lactose

Ket: Kesetaraan

List of Equipment:

Name Kapasitas Tanggal Tanggal Kalibrasi Tanggal

Kualifikasi Rekalibrasi
FBD 60 Kg 15/01/10 10/10/2020 10/10/2021
Dry Mixer Tank 100 Kg
Compressing 100.000 tab/jam
Machine Brand X
Coating Machine 100 kg
Brand Y
Sartopore atau Sartolone

Analytical Method

Kind of Testing SOP No. Analyst Tgl Kualifikasi Analys

Critical Proses Parameter

NO Stage Bahan Parameter Setting Actual

Wet Granulation
Dry Mixing
Compressing