8.D Establishing the scope of validation

Up08 Doris Borchert, PhD, Ralph Gomez, PhD

Here you will find answers to the following questions:

  • How can the scope of the cleaning validation be reduced to a manageable level?

  • How can “worst case” products be identified?

  • How can the product or equipment-specific validation scope be determined?

8.D.1 Bracketing: determination of critical substances


8.D.2 Matrixing: determination of equipment-specific validation protocols