We focus on the life cycle phase in qualification and validation

Take advantage of our expertise and experience for the increasingly important qualification and validation of equipment, systems, products and processes.

Corresponding requirements can be found in the EU GMP guidelines and their annexes. Examples are the requirements in Annex 11 for computer systems or in Annex 15 regarding the qualification of systems and equipment and the validation of processes and methods.

Since 2019, the European Commission has been preparing the implementation of the new ICH Q2 Guideline on the topic of product life cycle in the corresponding guidelines.

Life cycle assessment demands that all process- and plant-specific issues from commissioning to decommissioning are traceable. Examples for a plant are initial qualification, maintenance, and requalification, as well as modifications, repairs, and decommissioning, followed by archiving documentation.

Benefit from our experience and competence for your life cycle management

Take advantage of experienced external service providers for your full life cycle view and the resulting obligations.

Valicare has more than 20 years of experience in GMP qualification, validation, and consulting. The individual experience of our senior GMP consultants even goes beyond this period.

Backed with this expertise, we are happy to support you in all qualification and validation activities, independent of manufacturer and process. As a Syntegon subsidiary we also have access to expertise in the planning and construction of pharmaceutical processing and filling equipment, design and preparation of cleanroom concepts, and construction supervision. You will receive everything from a single source and have fewer contacts for your entire project.

An overview of our services:

• Support in planning your processes, methods, and equipment as well as in creating required specifications
• Design document review
• Preparation of technical and process-oriented risk-analyses (e.g. as FMEA) as basis for qualification and validation activities
• Preparation of your qualification/validation documentation

• Implementation of qualification/validation workshops
• Support during plant acceptance at suppliers or on site (FAT/SAT)
• Implementation of qualification, process development and validation, including procurement of required materials and provision of necessary measuring equipment
• Requalification and revalidation services for your system throughout its lifecycle

• Support in the decommissioning of processes and equipment

Moreover, our our special services regarding isolator technology and advanced therapy medicinal products (ATMP) makes us your first choice when it comes to service and support along the entire life cycle of equipment, processes, and products.