Progress has conducted successful Cleaning Validation projects for various (bio-)pharmaceutical clients in which evidence-based improvements have been implemented. With years of experience in organizing seminars and masterclasses, we also strive to share our knowledge and best practices with industry professionals.

Cleaning Validation is crucial to ensure product purity and effectiveness and patient safety. It involves obtaining documented evidence that cleaning procedures consistently remove contaminants, such as product residues, microorganisms, and cleaning agents, from production equipment to acceptable levels. Failure to implement robust processes can lead to cross-contamination, product adulteration and potential health risks to consumers.

Regulators, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require Cleaning Validation as part of current Good Manufacturing Practice (cGMP), as set out in Chapter 10 of Annex 15 Qualification and Validation, EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use: EudraLex_Volume 4_Annex 15.

By partnering with us, your operations will not only be effective, but also meet strict regulatory requirements. Our experts understand the critical importance of cleaning processes and the need for a compliant, yet efficient, realistic, and cost-effective operational business. This requires tailor-made, pragmatic, and risk-based approaches and solutions.

We serve clients with full package support and drive the necessary changes to create a culture of quality, efficiency, and compliance. We have the expertise to ensure that operational cleaning processes and their risk-related characteristics are understood, assessed for impact, validated, and mitigated if necessary. Progress offers various services: Consultancy, Project Management, Interim Management and Temporary Staffing.