Terminal Inspection in Pharmaceutical Industry
· Terminal inspection is the process for checking of defects in finished good prior to dispatch to market. The process is performed to check the effectiveness in finished good.
· The IPQA person Check the product particulars to be inspected as offered by the packing in charge.
· IPQA Personnel shall select randomly √n+1 of the total number of finished good. Whereas “n” is the total number of shipper of batch. Check the each & entire selected Corrugated box for following. Each Box shall be free from any defect.
Check the Corrugated box for the following. (But not limited to)
· Product Name
· Batch Number
· Manufacturing Date
· Expiry Date
· Quantity in shipper
· Condition of Corrugated Box
· Shipper Weight
· Shipper Label /Coding of Klass Marker
· Shortage of packing
· Colour of Klass Marker
· Rusted pins
· Condition of Tape
· Shipper fill weight within limit (check against weight sheet)
Open the Corrugated Box and check for the following. (But not limited to)
· Integrity and physical appearance of the pack.
· Coding on Monocarton/Inner Corrugated Box (coding should be legible).
· Batch Number, Manufacturing date, Expiry Date, MRP or Physician Sample.
· Packing orientation and packing style.
· Coding legibility
· Condition of shrink sleeve (if applicable).
· Condition of Can.
· Leakage of Gas/Bulk
· Color variation observed.
· Heavily Dented Cans
· Rust on Spray Cylinder
· Very poor sleeving on Cans
· Cracked Caps
· Cap Orifice availability (if applicable)
· Leakage observed.
· Correctness of Quantity/Number of units and sub-units in the corrugated box (Finished Pack) and subsequent inner packing.
· Any tear, breakage or damage of product or of any packing material which warrants and exhibits quality not conforming to the set standards etc.
· The IPQA Shall Record the defects/Correctness observed on the above parameters in Terminal Inspection Report
· if the defects warrants threat to the visual and intrinsic quality of the product then put the batch under hold and inform packing supervisor /in charge Production for the corrective actions.
· If During inspection any minor defects observed, then one shipper from forward and backward should be check to minimise the error. The IPQA Shall inform the Concerned for correctness.
· If any major defect is seen during inspection, ten shifts should be examined further and backward to reduce the error. IPQA will notify concerns for correctness
· If any critical defect observed, then 100% batch shall be checked & the batch shall be dispatch after complete rectification through deviation
· The defect can be categorised in Minor, Major, Critical as follow & suitable action shall be taken to minimize.
Possible Critical Defects (But not Limited) | Terminal Inspection in Pharmaceutical Industry
· Wrong Coding /Without Coding
· Can Printing defect
· Without actuator and Cap
The critical defects should be 0%.
Possible Major Defects (But not limited)
· Illegible Coding
· Colour Variation
· Dust Cap Crack
The major defects should not be more than 2%.
Possible Minor Defects (But not limited)
· Shipper damage
· Mono Carton damage
· Dirty cans
The minor Defects Should not be more than 3%.