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Question of the Week

What are the minimum requirements for in-process controls during the packaging process?

The minimum requirements for in-process control tests on the equipment in accordance with the EU GMP Guidelines Part I, Chapter 5.54 are:
  • General appearance of the packages
    Completeness of packages
  • Use of correct products and packaging materials
  • Printing accuracy
  • Error-free operation of the monitoring devices on the machine
[GMP MANUAL, Chapter 13.B.5]

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