In-Process control & Inspection for the Small Volume Injectable (SVPs)
The Process methods & Instructions are carried out as follows:
Raw Material
- The containers of raw materials to be checked for ‘Under Test’ and ‘Approved’ label
- There should be a check for material segregation.
- Raw material store should be checked for cleanliness.
Daily Water Testing
- D.M. Water and WFI testing should be done daily.
- Bio-burden of D.M. Water and Distilled Water should be checked and recorded daily.
Bulk analysis
- Bulk analysis should be done for every batch and it should be recorded giving details as product name, batch no. and remarks, if any.
Zero sampling
- Zero sampling should be carried out of containers required for manufacturing.
Sterilization
- Time, temperature and pressure of sterilization to be checked and recorded.
Volume Checking
- Volume should be checked daily of ampoules and vials and recorded.
Washing
- Jet pressure and laminar air flow reading to be checked daily for ampoules, vials and rubber plugs.
Optical Checking
- Checked ampoules and vials to be rechecked randomly and to be recorded.
Sterile Area
- Solution used for dipping of feet.
- Disinfectant used for cleaning sterile area.
- Working of UV Light to be checked and recorded.
- Display board of product along with Batch details to be placed in Vial filling \ ampoule filling areas.
- Cleanliness of vial and ampoule filling areas to be recorded.
- Nitrogen flushing and LAF reading of ampoule filling and vial filling area to be checked and recorded
- Semi-finished quarantine to be checked for labeling of containers and segregation.
- Finished goods quarantine to be checked for labeling of containers and segregation.
Packing
- Packing area to be checked for line clearance and cleanliness.
- Labeling and over-printing details to be checked.
