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SOP on Procedure for Checking of Strips / Blister and Overprinted Packing Materials.

  • Objective:To lay down a procedure for Checking of Strips / Blister and Overprinted Packing Materials.
  • Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company.
  • Responsibility
    • Production Supervisor / Officer shall be responsible for implementation of this SOP.
    • Head-Production / designee shall be responsible for compliance of this SOP.
  • Accountability:
    • Head-Production and Head QA shall be accountable for compliance of this SOP.
  • Abbreviations and Definitions:
  • SOP –  Standard Operating Procedure
  • Procedure
    • Production Checkers those are employed for checking of strips and overprinted packing materials shall check strips / blisters / coded materials for all the possible defects.
      • Some of the examples of types of rejection on packing line are:
        • Coding rejection.
        • Due to text matter/hologram/smudging of ink over printed foil.
        • Rejected strips due to cutting.
        • Empty pocket rejection.
        • Pocket puncture rejection.
        • Sealing rejection.
        • Over heated strips.
        • Chipped / capped / broken tablets.
        • Improper forming of blisters.
        • Improper appearance / absence of hologram in the final blister strip.
      • Some of the examples of types of rejections on coded materials which are checked offline after over printing of cartons/ labels and online during packaging operation.
        • Due to printed text.
        • Supplier rejection
          • Pasting rejection
          • Lamination rejection
          • Unwanted spots
          • Dirty cartons / labels / cache covers.
          • Excessive gum
        • Overprinting (coding) rejection.
      • The production checkers who feel uneasy or complain of headache are unfit for checking.
      • The medical examination of all checkers should include the report of proper vision with or without glasses and colour blindness also.
      • Checkers those are employed for checking of strips and overprinted materials shall be replaced with other trained checkers alternatively after every two hours.
    • Forms and Records:
    • Nil
  • Distribution
    • Master Copy Documentation Cell (QA)
    • Controlled Copies Production, Quality Assurance and Quality Control
  • History
Date Revision Number Reason for revision
00 New SOP

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 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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