The art of Cleaning Validation
The art of Cleaning Validation – Meeting the requirements for Cleaning Validation is complicated and indeed not a copy-paste task. It requires knowledge of law, guidelines, regulatory expectations and awareness of the latest industrial developments. Every company, product or production process is unique; that is why Cleaning Validation Life Cycle Management is primarily a matter of customization.
Progress-PME frequently receives requests from companies that have difficulty assessing whether their Cleaning Validation approach complies with the regulations, says Paul Tiemeijer Cleaning Validation expert from Progress-PME. He tells us that determining which method is adequate and best for the customer, requires expertise and a pragmatic approach. It often happens that the Cleaning Validation policy and procedures of companies do not meet the required standards. In some cases, this links to old processes and equipment, which are not entirely suitable to meet the current requirements. Regulatory expectations are also changing. For example; stricter rules about the Permitted Daily Exposure (PDE) within the EU, or process capability, on which the FDA is increasingly focusing.
Meet the requirements
Paul explains that for a correct Cleaning Validation approach, not only the proper procedures are required, but also good behaviour and awareness is necessary. My experience is that by increasing people’s awareness about Cleaning Validation, you create a culture that enhances chances to succeed and stay successful. Sharing knowledge is one of Paul’s passions and a reason why he likes to give training courses on this subject. Progress-PME regularly organizes specific training and seminars on cleaning validation.
Which route leads to improvement?
Based on a Quick Scan tool, Progress-PME first assesses the current status. After this, Progress-PME can, in consultation, optimize and adjust the policy and procedures. Based on the new procedures, a gap analysis is then carried out, concerning new and old equipment or facilities. Ultimately, a mitigation plan is proposed. “The added value we can provide, Paul says, is that every business has a different challenge, so a tailor-made approach is guaranteed and the opportunity to coach and train people is always available.”