|
Quality Control Process of Injection Powder |
| Procedure |
Control Point |
Item of Control |
Frequency |
| Water Purification |
Pure Water |
Conductivity, PH、Chlorid |
1time/2hours |
| Full Testing |
1time/Month |
| Injection Water |
Conductivity, PH,Chlorid, Ammonia |
1time/2hours |
| Full Testing |
1tims/Week |
| Cleaning and tidiness for Vial, Stopper and Cap |
Cleaning and tidiness |
Cleanliness,Appearance |
1time/Batch |
| Cleaned Vial, Stopper and Cap |
Cleanlinss |
1time/Batch |
| dried and Disinfected Vial, Stopper and Cap |
Cleanliness and Dry ness |
1time/Shift |
| Mixing, Formulation |
API and Secondary Material |
Name, Batch, Colour and Lustre , Assay, Coa |
1time/Batch |
| Split Charging |
Splited Charging Item |
Dosage and Clarity |
In any time |
| Cap Clamping and inspection |
Cap Clamping |
Cap Full, Airtightness |
In any time |
| Packing |
Packer Material |
Inspection for Foreign Body |
In any time |
| Label |
Content, Amount, Batch, Position and completed of Label |
In any time |
| Inner Packer |
Content,Amount,Record of Usage |
In any time |
| Label |
Content,Amount,Record of Usage |
Per Batch |
| External Packing |
Amount, Packinig list, Presswork |
Per Packer | | |
