Cleaning Validation

Cleaning processes have increasingly become a focus for FDA auditors. Cleaning validation is required to document that cleaning processes function as expected. The FDA expects that regulated companies will have:

• Written general procedures on how cleaning processes will be validated.
• General cleaning validation procedures to address who is responsible for performing and approving the cleaning validation, the acceptance criteria, and when  revalidation will be required.
• Specific written validation protocols in advance for the studies to be performed on each manufacturing system or piece of equipment which should address such issues as sampling procedures and analytical methods to be used, including the sensitivity of those methods.
• A final cleaning validation report which is approved by management and which states whether or not the cleaning process is valid. The data should support a conclusion that residues have been reduced to an “acceptable level”.

Cleaning Validation Services

Ofni Systems validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards.

Ofni Systems uses FastVal to write cleaning validation documentation, which allows us to complete validation projects in 70% less time than traditional documentation methods, allowing for more time in production and less time preparing documentation. Our goal in all cleaning validations is to improve the quality and value of your process while ensuring your customers’ safety and your compliance with all applicable regulations.

Ofni Systems can validate all of your systems. We can provide any level of service required, from validating test methods to automating cleaning validation reports to reviewing your quality system to ensure that you have a compliant cleaning program.

Cleaning Validation Methodology

Our validation experts will incorporate your cleaning protocols, SOPs, and methods into a suite of custom templates that allow for quick execution and turn-around of the cleaning validation.

Cleaning studies are initiated with the creation of a cleaning validation plan, complete with scheduling, role assignment, email notifications, and project tracking.

After a cleaning protocol is executed and cleaning samples analyzed, a cleaning validation report is generated to document that the cleaning process meets the defined requirements. Our cleaning validation documents are designed to demonstrate that your process meets all of your business requirements, plus regulatory requirements. All supporting reference material and documentation, including raw data and deviations, are linked via the FastVal system.

Finally, Quality Control review of the cleaning validation and report is documented, step by step, ensuring compliance and reporting accuracy.

Throughout the process, a Traceability Matrix is updated to ensure that all validation requirements are addressed. If necessary, a formal risk assessment can be created to identify areas for improvement.

Additional Resources

Additional information is available on:

• Cleaning Validation in FastVal
• Validating Computer Systems
  • Validating MS Access Databases
  • Validating MS Excel Spreadsheets
  • Validating Web Pages and Web Applications
  • Validating Mi-Co User Forms
  • Computer Software Validation