Essential GMP Skills:​ Facility Cleaning

This one-day, classroom and laboratory based, training course is hands-on and designed to ensure individuals working within GMP production facilities are well-prepared to maintain optimal aseptic production conditions by compliant cleaning behaviours and techniques complying with regulatory requirements and ensures the safe manufacturing processes in pharmaceutical and biopharmaceutical manufacturing.

Learning objectives:​

• Understanding GMP Principles by defining and explaining the importance of Good Manufacturing Practices (GMP) in facility cleaning and its impact on the final product.​
• Identify and select appropriate cleaning agents, sanitizers, and equipment for different areas within a GMP facility and understand the proper use and maintenance of cleaning equipment.​
• Define cleanroom classifications and their significance in pharmaceutical and biotech manufacturing and identify the specific cleaning requirements for different cleanroom classes.​
• Develop cleaning procedures and protocols and follow standardized cleaning procedures for various facility areas to minimize the risk of contamination using a digital SOP.​
• Understand the risks and potential sources of cross-contamination during cleaning activities and implement measures to prevent cross-contamination between different areas and equipment.​
• Validation and Verification of Cleaning Processes. Discuss the principles of cleaning validation and verification whilst understanding the importance of documenting and maintaining cleaning records.​
• Identify the appropriate use of personal protective equipment during cleaning operations and emphasize personal hygiene practices to prevent the introduction of contaminants.​
• Comprehend proper procedures for waste disposal in accordance with GMP standards.​
• Develop an understanding of emergency response procedures in case of spills or accidents during cleaning and know how to handle and report incidents related to cleaning activities.

Who should attend:

Individuals new to highly regulated industries such as biotherapeutics, advanced therapies medicinal products (ATMPs), or pharmaceuticals, and those currently working within these sectors wishing to gain a better understanding of the rigorous production facility cleaning requirements are best suited to this course. Appropriate for staff in Manufacturing, Quality Control (QC) and Quality Assurance (QA), personnel working in cleanrooms, validation and compliance personnel, Engineering and maintenance personnel amongst others.​​