Validaciones de procesos de limpieza

Validation of cleaning processes in a production plant, is fundamental to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment.

We should be certain that all equipment involved in the process and which is going to be in contact with the product does not contain any traces of active ingredients, particles, or any other type of residue which could affect the quality of our product, or even worse, the health and safety of the patients.

Qualipharma specialists have a consolidated experience in terms of cleaning validation method and processes.

Qualipharma can support you on the Validation of your administrative management, your environmental procedures and your internal management of residues and waste.

Facing the Cleaning Validation, we can find ourselves in front of two different possible scenarios:

  • Concurrent validation

  • Prospective validation

Qualipharma has the necessary experience and resources to support the creation of the correct documentation to demonstrate that the existing cleaning processes are efficient, or to design optimum cleaning processes.

  • Processes based on scientific knowledge and risk assessment
  • We provide constant support with the updated regulatory requirements and applicable regulations
  • Project involvement