What does the FDA expect from Cleaning Validation today?

FDA's regulations regarding cleaning validation are now relatively old. A GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES dates back to the early 90s. In this context, Warning Letters show the "current thinking" of the FDA.

The FDA expects a broader consideration, also with regard to other cleaning validation processes and a timetable for the completion of cleaning validation runs. It is explicitly required to provide:

• A plan showing how the cleaning processes, practices and validation study results are evaluated for each piece of multipurpose manufacturing equipment.
• A scientific rationale for the cleaning validation strategy that shows that the cleaning processes are effective.
• A summary about updating the cleaning validation protocol with - at least - the worst case scenarios: 
• - Evaluation of the medicinal products with the highest toxicity
• - Evaluation of medicinal products with regard to the lowest solubility in their cleaning agents
• - Evaluation of the characteristics of the medicinal products that are difficult to clean 
• - Swab sampling points of the locations that are most difficult to clean.

The FDA also requires an overview of the updated SOPs to ensure that an appropriate programme is in place to verify and validate cleaning processes for new products, processes and equipment.