Cleaning Validation: How to Prove the Effectiveness of Cleaning Procedures

Proactively ensure regulatory compliance and patient safety
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Why properly document cleaning validation?

Cleaning validation is the process of establishing evidence that cleaning procedures for manufacturing equipment prevents product contamination. Properly documented cleaning validation demonstrates current Good Manufacturing Practice (GMP) for finished pharmaceuticals. Active Pharmaceutical Ingredients (APIs) cross-contaminated with chemical residues and microbes compromise patient safety. Ineffective cleaning not only leads to more downtime and batch failures, but it also results in FDA rejection and costly fines because of drug adulteration.

Guide Questions to Cleaning Validation Effectiveness

1. Do you understand your process?

cleaning validation understanding the process

Effective cleaning validation clearly defines:

  • the solubility of the materials to be removed;
  • the design and construction of the equipment and surface materials to be cleaned;
  • the safety of the cleaning agent;
  • the ease of removal and detection,
  • the product attributes;
  • the minimum temperature and volume of cleaning agent and rinse solution; and
  • manufacturer’s recommendations.

Operational, validation, and laboratory personnel should understand all decontamination steps, process residue details, hold times, and worst cases related to the equipment and product. Quality managers should regularly evaluate acceptable limits, soiling conditions, and incoming raw material inspections. Related: Key Determinants in Validating Manufacturing Processes.

2. Does it comply with FDA regulations?

cleaning validation complying with FDA regulations

The FDA inspects pharmaceutical manufacturers to verify compliance with relevant regulations, such as the commonly violated Section 211.67 (Equipment Cleaning and Maintenance). To adequately prepare for FDA inspections, you can use a digital preparedness checklist, conduct paperless internal audits, and follow the Guide to Inspections Validation of Cleaning Processes. Effective cleaning validation reduces quality costs, maintains product integrity, and improves patient safety. Related: Types of FDA Inspections.

3. Is it cost-effective?

cleaning validation cost-effective app

If a pharmaceutical facility manufactures various products, multifactorial inputs in the manufacturing process makes cleaning validation more difficult. The monitoring strategy for cleaning validation should be well-documented, especially for manual cleaning procedures and visual inspections. Paper-based cleaning validation, reporting, and recordkeeping can be challenging and time-consuming.

Optimize your process, improve GMP compliance, save time, and increase productivity with iAuditor, the world’s most powerful inspection software. Easily perform scheduled inspections, internal audits, and site walkthroughs using mobile devices. Prove the effectiveness of cleaning validation through proper documentation with iAuditor:

  • Access ready-to-use cleaning validation checklists
  • Schedule regular inspections and receive instant notifications
  • Take or attach photos of non-compliance and add annotations
  • Automatically generate comprehensive reports that are securely saved in the cloud
  • Instantly share reports to key personnel
  • Assign corrective actions with a priority level and due date
  • Track performance of the cleaning validation program with real-time analytics