Qualification & Validation

As engineering service providers and process developers with expertise in the life sciences, our clients rely on us to help them meet the requirements of international approval authorities for GMP-regulated pharmaceutical plants. Our specialists can advise you in all questions regarding Good Manufacturing Practice (GMP) and provide you with on-site support for qualification and validation measures. Through audits we can show you potentials for further improvement.

Step by step, we analyze your qualification and validation needs, draw up plans and implement the appropriate measures. We offer complete documentation of everything from your Validation Master Plan, to detailed qualification plans including installation (IQ), operational (OQ), and performance qualification (PQ), to detailed test descriptions. We also revise and write Standard Operating Procedures (SOPs) for the operation of your plants, as well as for the production processes. All results will be documented according to GMPrequirements. In addition, Axiva offers audits of existing documentations.

Thanks to many years of experience with the operation and control of various production plants, we are well versed with the day-to-day business of GMPregulated pharmaceutical production. Due to this experience we are your competent partner in the search for reliable and optimal production processes. When it comes to conceptualization, analysis, implementation or documentation of manufacturing processes, we can handle all your process validation questions and offer you support with validation runs. We will qualify your equipment and process controls, as well as your computerized systems, while taking considerations such as cleaning validations into account.

Our experts are involved in the creation of relevant regulations, since they are members of standardizing committees and working groups. This keeps our know-how up-to-date. In GMP plants, cleanrooms are crucial for the guaranteed adherence to product surroundings requirements. For this reason, Axiva also offers extensive services in the area of cleanroom design.