Sunday, 26 September 2021

Terminal inspection in pharmaceutical industry

 

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.

Terminal inspection in pharmaceutical industry

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

·         Leakage

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%.

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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