Cleaning Validation is a critical regulatory requirement in the pharmaceutical, biotechnology and medical device industry. The purpose of cleaning validation is to establish evidence that the cleaning process will consistently yield results that meet predetermined specifications. The goal of the cleaning process is to remove the following:

  • All components from the previous product
  • Bioburden
  • Endotoxins
  • Detergents

Cleaning validation is performed early in the lifecycle of process and manufacturing equipment and prior to GMP manufacturing operations. During the lifecycle of GMP manufacturing equipment and product, cleaning validation is required when changes are performed to the process or equipment and during revalidation activities. During the cleaning validation lifecycle, a significant amount of data and information is generated in paper-based documents and records. Cleaning validation records and data is normally located in binders that are stored in onsite document archives or offsite storage provided by a third-party vendor

Unfortunately, cleaning validation data generated during the lifecycle is not readily available and integrated for easy retrieval and analysis. Because cleaning validation data is found in paper-based records this data cannot be stored, managed and reported using data mining and reporting tools.

Cleaning validation traditionally is a manual inefficient paper-based process that is plagued with inadequate cycle times and high cost. There is a significant amount of challenges and compliance risk associated with paper-based cleaning validation.

The inefficiencies and high cost associated with traditional validation is related to the following manual activities:

  • Printing
  • Executing and scanning validation
  • Archiving
  • Document control resources

Managing the cleaning validation lifecycle with paper-based documents create a significant amount of compliance risk. The compliance risk is associated to the fact that all data is controlled and secured using procedures instead of technical controls which are more reliable. The compliance risk associated with paper-based cleaning validation includes the following:

  • Unable to enforce consistency
  • Challenges related to standardizing and harmonizing the validation process across sites
  • Good Documentation Practices issues
  • Lost and misplaced records
  • Regulatory observations
  • Data integrity
  • Inability to enforce and follow approved procedures
  • Difficult to enforce and execute against the equipment validation master plan

Traditional cleaning validation can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to access and review data in a single repository.

ValGenesis validation lifecycle management systems provide the industry top solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes. ValGenesis eliminates paper based cleaning validation protocols and enable the ability to perform electronic executions, provides a centralized repository of data and information during the cleaning lifecycle.

About the Author

cloud-sun Ivan Soto is the Director Client Engagement and Product Strategy, he is responsible for managing the product lifecycle, strategy and overall client experience. Ivan Soto has been in the industry for over 20 years, and held several technical and management positions at different Pharmaceuticals companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.
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