1. Do you understand your process?
Effective cleaning validation clearly defines:
- a. the solubility of the materials to be removed;
- b. the design and construction of the equipment and surface materials to be cleaned;
- c. the safety of the cleaning agent;
- d. the ease of removal and detection,
- e. the product attributes;
- f. the minimum temperature and volume of cleaning agent and rinse solution; and
- g. 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
3. Is it cost-effective?
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