Sunday, 11 March 2018

What to make of the draft EU GMP Annex 1?

In a forthright article for PharmTech, Russell Madsen, James Agalloco, James Akers take aim at the new draft Annex 1.

The authors state: “The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.”

The critique assesses:
  • Inconsistent use of and undefined terminology
  • Incorrect application of technology
  • Technical process errors
  • Application of risk analysis
  • Unusual concept of sterile product manufacture
The article can be read here: PharmTech

Posted by Dr. Tim Sandle

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