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Quality Control Process of Lyophilized Powder Manufacturing

Quality Control Process of Lyophilized Powder Manufacturing

Procedure Control Point Item of Control Frequency
Water Purification Pure Water Conductivity, PHChlorid 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

Correlative Content: 

Facilities in the Workshop of Lyophilized Powder IProcess Flow Diagram For Lyophilized Powder Inject
Powder for Injection(Cephalosporins),Lyophilized P

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