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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