What does "GMP-compliant Equipment Design" mean?

What does "GMP-compliant equipment design" mean? This question, which is asked very often, can be answered briefly but not very precisely at first glance: The manufacturing equipment must not have any (negative) influence on the product. Other such vague points are: Compliance with the state of the art and suitability for the intended purpose.

How these requirements are to be understood is the main content of the 115-page ECA GMP-Equipment Design Guide. This new Guide cannot illustrate the requirements for every possible type of production equipment. Wherever possible, however, it nevertheless refers to specific materials, values and parameters that have either proven to be adequate or are required by authorities. The following aspects, among others, are covered:

  • Material selection
  • Surface qualities
  • Hygienic design
  • Geometries
  • Documentation and
  • Quality assurance in equipment design.

This document will me made available to all attendees of the ECA online course "GMPs for Equipment, Facilities & Utilities", 9-11 April 2024.

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