Expertise Validation & Testing Process & Cleaning Validation

Process & Cleaning
Validation

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.

Agidens Automation project at Akorn 14
Life Sciences

Design & Build of Formulation Suspension Facility

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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
  • Timetable
Cleaning Validation

Cleaning validation

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)

 

TAKE YOUR PROCESS & CLEANING VALIDATION TO THE NEXT LEVEL

Do you like our approach? We would love to hear from you!

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