Validation and Process Design

During the development of products and processes failure can be made.  Research has shown that if those mistakes are discovered later in the design process, the repair costs increase sharply. This also applies to process development in the Life Sciences.

Often those errors a result of wrong assumptions and they are all from the beginning in the product and process specifications processed. That is why it is important that the correct specifications are formulated in advance. ValserV has extensive experience in the development and preparation of product specifications and process specifications for the medical device and pharmaceutical industry and can serve you in this Design Stage.

Product and Process Design

In the development of the product and process these are my principles:

  • Planning of the product and process design
  • Quality of design – take account of the requirements
  • Risk management – reducing risks
  • Lean Six Sigma – practical and efficient work

The specifications are characterized by:

  • Critical Process Parameters
  • Critical Quality Attributes
  • Clear Process Limits
  • Practical Test Methods