Project Description

  • processes validation

Process Validation

The Process Validation, despite being requested in the Brazilian pharmaceutical industries since the end of 90’s, it still causes controversy and questioning about the correct way of its execution and the conduction of the study.

Since is about an extremely careful study and requires a deep technical knowledge, this can be easily questioned during the ANVISA inspection, if not conducted correctly, if presented mistakes or margin for doubt.

The Passarini Regulatory Affairs has specialists that will help your company in the elaboration of your Validation Master Plan (VMP) and in the development of the activities contained on it.

Besides, we also will guide in the required adjustments that may preclude any validation, always seeking for the qualification and development of the designated team for the project.

See below some validation examples:

  • Weighing and manufacturing of the half-finished (this two may be incorporated in the same study) – in case it is a medicinal pill, a study must be performed until the encapsulation phase.
  • Holding time.
  • Primary package

  • Secondary package.
  • Weld.
  • Painting.
  • Clean room.
  • Sterile package.
  • Cleaning and passivation.
  • Water and air system.


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