how in process checks performed in sterile area like volume checking its limits and other tests to be performed by quality assurance in sterile area?
Depending upon the type of sterile formulation in process checks are being carried out.
you need to be specific for your question.
The general test are as follows:
- Weight / fill volume should not be less than label claim or not more than 2%/3% of label claim
- Challenge for all sensors ex- No product no filling test.
- Torque test- as per INH SOP.
- Sealing/overprinting and embossing check- the number of sample for test shall be as per SOP.
5.All challenge test for secondary packing for the functioning of sensors as per defined frequency in SOP.