Validation

Cleaning

Recent increases in drug potencies, patient sensitivity and harmful failures have led cleaning processes to receive extensive scrutiny from the FDA. The importance of cleaning verification and validation is made even more important when it isn’t feasible to use dedicated equipment for a given process or product.

QSP can help with any size need, from providing associates to perform routine tests to developing a comprehensive cleaning validation program. The engineering and science professionals at QSP understand the criticality of cleaning processes and through careful design and analysis can help you ensure the effectiveness of yours. We provide expert guidance in establishing validation test protocols, setting residue and cleanliness acceptance criteria, developing sampling plans and working with either your laboratory or a third party to ensure test methodology is adequately sensitive and accurate.

Our team is experienced in developing and executing:

• Cleaning process development
• Cleanliness specifications
• CIP qualification and validation studies
• Cleaning and sterility sampling plans
• Risk Assessments Validation Master Plans
• Validation study protocols
• Standard Operating Procedures (SOP)