Validate Cleaning Procedures for Both Dedicated and Shared Equipment

Validate Cleaning Methods for All Equipment—Shared or Dedicated

Remember: Cleaning validation is mandatory for all equipment types to prevent contamination and ensure residue removal.

Why This Matters in GMP

Both dedicated and shared equipment must undergo cleaning validation to demonstrate that residues from previous batches, cleaning agents, or microbes are effectively removed. Failure to validate cleaning can lead to cross-contamination, impacting product safety and efficacy. For dedicated equipment, validation proves consistency over time; for shared equipment, it’s essential for product changeovers. Regulatory agencies expect documented, scientifically justified cleaning procedures, along with recovery studies and acceptance limits. Without validation, batch release is compromised and contamination investigations become challenging. This practice forms a cornerstone of GMP process control and product integrity.

Also Read: Conduct Risk Assessments Before Implementing Process Changes

Regulatory and Compliance Implications

FDA 21 CFR Part 211.67 requires cleaning procedures to be validated and documented. EU GMP Annex 15 outlines cleaning validation expectations, particularly for shared equipment. WHO GMP and Schedule M reinforce that all manufacturing equipment must be qualified for cleaning. Auditors examine cleaning protocols, analytical methods, and swab/rinse test results. Inadequate or unvalidated cleaning is often cited as a critical deficiency. Non-compliance may result in product recall, warning letters, or facility shutdowns. Validated cleaning ensures compliance, reduces risk, and supports robust quality systems.

Implementation Best Practices

Perform risk-based cleaning validation for both product contact and non-contact surfaces.
Define worst-case products and establish acceptance limits based on toxicology and solubility.
Use swab and rinse sampling methods validated for recovery and specificity.
Document cleaning validation protocols, results, and revalidation timelines in SOPs.
Link cleaning validation to change control, equipment maintenance, and batch release processes.

Also Read: Navigating Data Integrity in the World of Pharmaceuticals

Regulatory References

FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
EU GMP Annex 15 – Cleaning Validation
WHO GMP – Cleaning and Contamination Control
Schedule M – Cleaning Procedure Requirements