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

July 31, 2016January 13, 2024 Pharmaceutical Guidanace

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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