|
Quolity Control Process of Tablet Manufacturing |
| Procedure |
Control Point |
Item of Control |
Frequency |
| Materials |
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 |
| Granulating |
Particles |
Concentration & Temperature of Binding Agent |
1time/batch |
| Assay of water |
2time/batch |
| Fluidity of particles |
1time/batch |
| Granule Modification |
Particles |
fineness |
1time/batch |
| Batches Mixing |
API and Seconary Materials |
Assay、evenness degree |
1time/batch |
| Tablet Press |
Tablet |
Appearance |
In all time/Batch |
| Discrepancy of Talbet Weight |
In all time/Batch |
| Hardness, Brittleness |
1time/batch |
| disintegration time limited |
1time/batch |
| Aluminium Plastic Packing |
|
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 |
