GMP Life Cycle Management

When planning the qualification and validation activities of facilities, equipment, systems, products and processes, their life cycle phase is crucial!

Take advantage of the extensive and long-standing experience of Valicare's experts and let them support you comprehensively and competently in all lifecycle phases.

Consideration of the entire life cycle has become increasingly common in recent decades and now applies to almost all processes and methods as well as plants, equipment and computer systems. 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 with regard to 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.

In the life cycle assessment, all process- and plant-specific issues from commissioning to decommissioning must be ensured. Examples for a plant are initial qualification, maintenance, requalification but also modifications, repairs and decommissioning. Furthermore, archiving documentation, because access to important data must continue after a plant has been decommissioned.

Benefit from our experience and competence for your life cycle management

For a full lifecycle view and the resulting obligations, the support of experienced external service providers is a good solution.

Valicare has over 20 years of experience in GMP qualification, validation, and consulting, however the individual experience of our senior GMP consultants goes still beyond this period.

With our expertise, we support you in all necessary activities, independent of manufacturer and process. As a subsidiary of Syntegon Technology GmbH, we can also offer services such as the planning and construction of pharmaceutical process and filling plants, preparation of clean room concepts and construction supervision. The advantage is that you get everything from a single source and thus have one or at least fewer contacts for the entire project.

Find here some of our services:

• Support in the planning phase of your processes, methods and equipment as well as in the creation of the 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.
• Perform requalification and revalidation services for your system throughout its lifecycle.
• Support in the decommissioning of processes and equipment

Also with our special service offers concerning the isolator technology or the advanced therapy medicinal products, ATMPs, we support our customers over the entire life cycle of the plants, processes and products.