Cleaning Validation: How to Prove the Effectiveness of Cleaning Procedures
Proactively ensure regulatory compliance and patient safety
Mobile documentation, auto-generated reports, and cloud storage with a GMP compliance software
Published March 26th, 2020
Why properly document cleaning validation?
Cleaning validation is the process of establishing evidence that cleaning procedures for manufacturing equipment prevents product contamination. Properly documented cleaning validation demonstrates current Good Manufacturing Practice (GMP) for finished pharmaceuticals. Active Pharmaceutical Ingredients (APIs) cross-contaminated with chemical residues and microbes compromise patient safety. Ineffective cleaning not only leads to more downtime and batch failures, but it also results in FDA rejection and costly fines because of drug adulteration.
1. Do you understand your process?
Effective cleaning validation clearly defines:
- 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 detection,
- the product attributes;
- the minimum temperature and volume of cleaning agent and rinse solution; and
- 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.
2. Does it comply with FDA regulations?
The FDA inspects pharmaceutical manufacturers to verify compliance with relevant regulations, such as the commonly violated Section 211.67 (Equipment Cleaning and Maintenance). To adequately prepare for FDA inspections, you can use a digital preparedness checklist, conduct paperless internal audits, and follow the Guide to Inspections Validation of Cleaning Processes. Effective cleaning validation reduces quality costs, maintains product integrity, and improves patient safety. Related: Types of FDA Inspections.
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
Take advantage of iAuditor's ready-to-use Cleaning Validation checklists for free:
This template is used to complete the process validation protocol by reporting the verification of the equipment/system final design against the user, functional, and/or design specifications. Easily identify key equipment parts, utilities supply, and environmental requirements.
Pharmaceutical GMP Audit
Perform systematic audits of a pharmaceutical manufacturing facility and measure compliance with GMP guidelines, including equipment control and cleaning validation. This template has been converted to iAuditor from the ISPE GMP Audit Checklist for Drug Manufacturers.
FDA Inspection Preparedness Checklist
Use this checklist as an aid to prepare the personnel, site, and documentation needed before an FDA compliance inspection. Determine red flags to help prioritize what still needs to be done and measure the readiness of the facility using scoring.
Pharmaceutical 5S Manufacturing
Help your business improve productivity through workplace cleanliness and efficiency. Eliminate unnecessary items stored in the manufacturing site and ensure machines, equipment, and tools are kept clean and in working order.
Assess the overall cleaning and disinfecting practices, sterile preparation compounding, and infection control in pharmacies. Easily inspect the attire, hygiene, and aseptic technique of pharmacy staff members, storage and waste management, and primary engineering controls.
FDA MDSAP Audit
This digitized MDSAP template is based on the US FDA’s MDSAP QMS Internal Assessment Checklist. Evaluate how aligned is the company’s QMS to MDSAP, including release of products and services, control of non-conforming outputs, and performance improvement.