|
Quolity Control Process of Capsule Manufacturing |
| Procedule |
Control Point |
Item of Control |
Frequency |
| Material |
API and Seconary Materials |
Foreign Body, Full Testing |
Per Batch |
| Pulverization |
Pulverization |
Foreigh Body, fineness |
Per Batch |
| Weight and Proporation |
Feeding |
Variety,Quantity |
1time/Batch |
| Granule |
Particles |
Concentration & Temperation of Binding Agent |
1time/Batch |
| Assay of water |
1time/Batch |
| Fluidity of paticles |
1time/Batch |
| Batches Mixing |
API and Seconary Materials |
Assay、evenness degree |
1time/batch |
| Capsule Filling |
Capsules |
Appearance |
In all time/batch |
| Discrenpancy of Capsule weitht |
In all time/batch |
| Disintegration time limited |
1time/batch |
| Buffing |
Capsules |
Appearance |
1time/batch |
| Aluminium plastic Packing |
Aluminium-plastic composite panel |
Appearance |
In all time/Batch |
| Outleakage, airtightness |
In all time/Batch |
| Packing |
Inner Packing |
Quantity, Package Instert |
In all time/Batch |
| Labeling |
Label, Amount, Record of usage |
1time/batch |
| External Packing |
Presswork, Amount,Packing List |
1time/batch |
