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Quality Control Process of Lyophilized Powder Manufacturing |
| 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 |
| Filted Pure and Injection water |
Clarity |
1time/Batch |
| Formulation and Filtration |
Weighting |
Name, Batch no. Specs,Coa |
1time/Batch |
| Formulation Solution |
Assay,PH,Clarity, Colour and Lustre |
1time/Batch |
| Filter Membrane |
Bubble Point |
1time/Batch |
| Filling and Corking |
Filled and Corked Item |
Filling, Measure, Clarity,Corking |
In all time/Batch |
| Lyophilizing |
Lyophilized Item |
Clarity Appearance |
1time/batch |
| Cap-Clamping, Inspection |
Clamped Item |
Cap Full, Airtightness |
In all time/Batch |
| Packing |
Batch No. |
Checking |
1time/Batch |
| Labeling |
Content,Amount,Record of Usage |
In all time/shift |
| Inner Packing |
Amount, Package Insert, Label |
In all time/shift |
| External Packing |
Amount, Packinig list, Presswork |
In all time/shift | | |
