Never Clean Equipment While a Batch is in Process Under GMP

Do Not Perform Equipment Cleaning During Active Batch Processing

Remember: GMP prohibits equipment cleaning during active batch production—this can lead to cross-contamination, misdocumentation, and product rejection.

Why This Matters in GMP

Once a batch is in process, any cleaning activity—internal or external—on the associated equipment can disrupt process control, introduce moisture or cleaning agents, or compromise traceability. It creates ambiguity around which product residues belong to which batch and challenges the integrity of manufacturing records. This practice is also prone to undocumented changes or missed cleaning steps. GMP mandates that equipment cleaning occur only before or after production, not concurrently, to preserve batch identity and ensure clear documentation.

Also Read: Using Periodic Knowledge Checks to Strengthen Quality Culture

Regulatory and Compliance Implications

FDA 21 CFR Part 211.67(a) specifies that equipment must be cleaned before use and between batches, not during processing. EU GMP Chapter 5 requires equipment to be free of residues and clean before production starts. WHO GMP and Schedule M emphasize process segregation and equipment status controls. Auditors review equipment logbooks, batch manufacturing records (BMRs), and cleaning records. Overlapping cleaning and manufacturing timelines are red flags and may trigger CAPA or investigation demands.

Implementation Best Practices

Clearly indicate equipment status using visual tags

(e.g., “In Use,” “Cleaned,” “Under Maintenance”).

Establish SOPs restricting any cleaning during active batch runs, with exception-based deviation reporting.

Train production staff to plan and schedule cleaning only post-batch or during approved downtime.

Verify that all cleaning records are separate from ongoing batch processing documentation.

Audit logbooks for conflicts in cleaning and manufacturing entries and resolve discrepancies through QA.

Regulatory References

FDA 21 CFR Part 211.67 – Equipment Cleaning and Use Controls
EU GMP Chapter 5 – Equipment and Process Control
WHO GMP – Production Hygiene and Equipment Status
Schedule M – Cleaning Timing and Batch Segregation