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

 

 

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