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In-process Checks during Secondary Packaging Operations

July 27, 2021January 28, 2024 Pharmaceutical Guidanace

In-process Checks during Secondary Packaging Operations

Performed in In-process quality checks as pre-defined frequency in BPR and to be sorted out the strips/blister with below-mentioned tablet defects before packed in carton or during Packing

Broken Tablets
Laminated Tablets
Chipped Tablets
Discoloured Tablets
With Black particles Tablets
With foreign particle Tablets
Distorted Tablets
Improper Batch coding details on Strips/Blisters
Legibility of Batch coding details on strips, missing of letters or smudging of ink.
of Empty Pockets.
Proper forming of blister – any irregularity in the shape of blisters
Proper cutting of the strips/Blister
Appearance of the strip: Check the strips/Blister
For poor knurling,
Hologram creasing on foil and
Faulty printing such as ink lining; ink patches and poor legibility of printed letters.

Numbers of strips in one carton/cache cover as per required pack size:

Check each carton or cache cover for the total number of strips and verify the results with pack size mentioned in the Batch packaging Record.

Number of unit cartons in one multicarton as per required pack size:

Count the number of unit cartons in one multi-carton and verify with the pack size mentioned in the technical directions, packaging and outer carton.

Presence of package insert/ Patient information leaflets:

Before final closing of carton / unit cartons ensure the presence of package insert in each carton / unit carton, wherever applicable.

Proper insertion of tuck-in flaps:

Check whether the tuck-in flaps of the cartons are properly inserted and locked with the supporting flaps or not.

Proper gluing of side seam/bottom lock of carton/cache cover:

The sealing of side seam and lock bottom flaps of carton / cache cover should be intact and shall not show any opening.

Batch details on carton/ cache cover:

Check the batch details as per batch packaging record and also observe for legibility of letters, missing of letters or smudging of ink etc

Proper sealing of polyolefin shrink-wrap film:

Check whether the shrink-wrapping is proper done and is properly tight.

Sampling

Finished goods, control samples& stability samples shall be collected& recorded

Weighing of Carton

Maximum and minimum range for Carton shall be set by weighing of 10 cartons and shall be recorded.
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