In-Process control & Inspection for the Small Volume Injectable (SVPs)

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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.

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