Is Your Cleaning Schedule Really GMP-Compliant or Just a Routine?

Many manufacturers think a daily cleaning schedule automatically means they meet Good Manufacturing Practices (GMP). But the truth is — a cleaning routine is not always the same as GMP compliance.

Auditors don’t just look for cleaning frequency — they check whether your cleaning process is documented, validated, and proven effective. A routine without GMP verification could put your certification and product safety at risk.

🚫 Common Signs Your Cleaning Schedule Is NOT GMP-Compliant

• No Written SOPs

  • Staff clean based on habit, not standardized procedures

  • No specific instructions on cleaning methods, tools, or chemicals

• No Validation of Cleaning Effectiveness

  • No swab tests or microbial checks after cleaning

  • Relying only on visual inspection

• Poor Documentation

  • Cleaning logs are incomplete or missing signatures

  • No record of chemical concentrations or contact times

• One-Size-Fits-All Approach

  • Using the same cleaning schedule for all equipment, regardless of risk level

  • No differentiation between high-care and low-care areas

• Untrained Cleaning Staff

  • Staff not trained in GMP cleaning requirements

  • No refresher training for long-term workers

📋 Key GMP Requirements for a Cleaning Schedule

• Written SOPs: Step-by-step instructions for cleaning each area and equipment

• Defined Frequency: Clear schedules based on risk assessment

• Validated Methods: Use ATP tests, swabs, or lab analysis to verify cleaning effectiveness

• Proper Chemical Use: Documented concentrations, contact times, and safety data

• Record Keeping: Signed and dated cleaning logs kept for audit purposes

• Training: Ongoing GMP training for cleaning personnel

• Segregation of Tools: Colour-coded tools for different zones to prevent cross-contamination

🛠 Steps to Upgrade Your Cleaning Routine to GMP Level

• Review and rewrite cleaning SOPs to meet GMP standards

• Introduce verification methods (ATP, swabs, microbiological tests)

• Train staff on GMP cleaning and proper chemical handling

• Use risk-based cleaning frequencies for different zones/equipment

• Maintain an audit-ready cleaning log system

• Replace old tools with colour-coded, GMP-approved cleaning equipment

⚠ Risks of Having Only a “Routine” Cleaning Schedule

• Audit Non-Compliance: Failure to meet GMP documentation and validation standards

• Cross-Contamination: Ineffective cleaning can spread harmful microorganisms

• Product Recalls: Increased risk of contamination incidents

• Reputation Loss: Customers lose trust after safety breaches

💡 Pro Tip: A true GMP-compliant cleaning schedule is evidence-based, documented, validated, and consistently followed — not just “done daily.”