Process & Cleaning
Process validation guarantees a focus on patient safety, product quality, and data integrity for both producers and consumers. Moreover, Agidens offers guidance and assistance for cleaning activities in laboratory and pharmaceutical production settings.
In order to get stability in the production process, it is fundamental to detect and address any deviations. Our way of working is based
on a quality by design’ approach.
STABILITY THROUGHOUT THE ENTIRE PRODUCT LIFE CYCLE
Process validation starts from the process design and guarantees the stability of the product throughout the entire product life cycle. Each part of the process is evaluated separately and forms an integral part of the final assessment of the process. This may include equipment, materials or software.
In order to get stability in the production process, it is fundamental to detect and address any deviations. Producers need to know the presence and frequency of deviations, as well as the cause and its impact on the end products.
Design & Build of Formulation Suspension FacilityRead more
CLEAR PROCESS VALIDATION PLAN
We thoroughly map the validation plan and provide all necessary quality documentation.
- A brief description of the process with an overview of the critical process steps or critical process parameters which are monitored during validation.
- Details of the analytical methods
- Sampling plan: where, when and how are samples taken
Agidens is committed to helping you create a comprehensive Master Validation Plan for cleaning, working closely with your quality department. Our partnership ensures compliance with guidelines and standards, both within Europe and beyond, while aligning daily operations with GMP guidelines when needed.
Our cleaning validation services cover all aspects, including developing system-specific protocols, planning daily execution, analyzing results, and training your employees. Moreover, we can provide specialized personnel on a temporary basis or support specific projects when necessary, delivering a seamless, tailored approach to your cleaning validation needs.
WHY AGIDENS FOR PROCESS & CLEANING VALIDATION?
- Our way of working is based on a ‘quality by design approach’
- Extensive experience with process validation of complex and extensive production processes
- We carry out the process validation for both sterile and non-sterile processes
- The approach ensures that the processes comply with EU and FDA regulations
- We provide an integrated team with expertise from all relevant disciplines (process engineering, quality assurance and production)
Computer System Validation
CSV provides producers with documented proof that the computerized/automated system performs consistently and in compliance with all regulations involved.
Analytical Instrument Qualification
The reliability of equipment, accuracy and the integrity of analysis results are of great importance. We support you with our permanent endeavor to comply with all regulations by making use of solution-oriented, multidisciplinary consultants.
Commissioning & Qualification
GxP guidelines require a science and risk based life cycle approach for processes, installations and instruments. An essential part of process validation is demonstrating that the systems used are under control throughout the life cycle.
As the Life Sciences industry evolves, mastering temperature control and compliance is non-negotiable. Uncover the indispensable role of Thermal Validation services in providing tailored solutions for sterilization and controlled storage processes.