Cleaning Validation

Proactively ensure compliance with cleaning validation regulations to ensure drug safety for patients

Why should a cleaning validation be properly documented?

Cleaning validation is the process of demonstrating that cleaning procedures for manufacturing equipment prevent product contamination. A properly documented cleaning validation provides evidence of current Good Manufacturing Practice (GMP) for finished medicinal products.

Active pharmaceutical ingredients (APIs) that are cross-contaminated with chemical residues and microbes endanger patient safety. Ineffective cleaning procedures not only lead to more downtime and batch errors, but also to rejection by the FDA and costly fines due to drug adulteration.

Questions about the effectiveness of the cleaning validation

1. Do you understand the process?

An effective standard cleaning defined:

  • 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 recognition
  • the product attributes
  • the minimum temperature and volume of detergent and rinse solution
  • Recommendations of the manufacturer

Operating, validation and laboratory personnel should understand all decontamination steps, details of process residues, waiting times and worst cases related to the equipment and product. Quality managers should regularly evaluate acceptable limits, contamination conditions and incoming raw material controls.

2. does it comply with FDA regulations?

The FDA inspects drug manufacturers to verify compliance with relevant regulations, such as the frequently violated Section 211.67 (Cleaning and Maintenance of Equipment).To adequately prepare for FDA inspections, you can use a digital readiness checklist, conduct paperless internal audits, and follow the standard cleaning process validation guide for inspections. Effective cleaning validation reduces quality costs, maintains product integrity and improves patient safety (clean room validation).

3. Is it Cost-Effective?

When a pharmaceutical facility produces multiple products, multifactorial inputs to the manufacturing process make standard cleaning difficult. The monitoring strategy for cleaning validation should be well documented, especially for manual clean procedures and visual inspections. Paper-based cleaning checks, reporting and accounting can be challenging and time-consuming.

digitize your cleaning validation

Optimize the process, improve cleaning validation GMP compliance, save time and increase productivity with Lumiform Perform scheduled inspections, internal audits and site tours easily with mobile equipment. Prove the effectiveness of cleaning validation by properly documenting with Lumiform:

  • Access to ready-to-use checklists for cleaning validation
  • Plan regular inspections and receive immediate notifications
  • take or attach photos of non-compliance and add comments
  • Automatic generation of comprehensive reports that are securely stored in the cloud
  • Immediate forwarding of reports to key persons
  • Assign corrective actions with a priority level and a due date
  • Track the performance of the cleaning inspection program with real-time analysis

Featured templates

Process Validation Report Template

Process Validation Report Template

Such a template is used in the pharmaceutical industry to document everything properly. See template

Process Validation Protocol - Operational Qualification Template

Process Validation Protocol - Operational Qualification Template

Use this template to complete the process validation protocol for an operational qualification. See template

Process Validation Protocol - Equipment Qualification Template

Process Validation Protocol - Equipment Qualification Template

Use this template to report the verifying of the equipment/system final design. See template