Manufacturer validation

We want to know each new product, remain process proficient and never leave you to fend for yourself in the event of deviations. Our aim is a consistent high level of product quality while still bearing all economic aspects in mind.

Three criteria that we focus on in terms of the validation process:  risk evaluation in compliance with ICH Q9, the validation plan and the variance analysis including remedy measures.

Our many years of experience in production go into the risk analysis of which each validation plan is based on. Even though each process of each batch is continually monitored, validation is not necessarily mandatory. Concentrating on genuinely critical points sharpens the focus and ultimately saves you time and money.

The result of the analysis is always individualized to the project and takes your special needs and requirements into account.

The validation plan is a summation of the process, the risk analysis and necessary analytics. Should the product require improvement in advance, our team is ready to assist with expertise, facilities and experience.

A variance analysis indicates where there is room for improvement. We provide consultation on concrete remedy measures and work with you to implement them.