Monday , September 25 2023

In-process Checks during Secondary Packaging Operations

In-process Checks during Secondary Packaging Operations

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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
  1. Proper sealing of polyolefin shrink-wrap film:
  • Check whether the shrink-wrapping is proper done and is properly tight.
  1. Sampling
  • Finished goods, control samples& stability samples shall be collected& recorded
  1. Weighing of Carton

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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