Cleaning and Cleaning Validation
Is it permissible to use the same equipment to manufacture different products for different therapeutic groups?
What would be the clean down arrangements/requirements when switching between different product types?
R&D want to share manufacturing equipment used for fully marketed product, as QP what are your concerns.
What are the carry-over limits for impurities in products.
Tell me about cleaning validation for a multi product facility when full toxicity/potency etc. data is not available.
How would you apply your knowledge of therapeutics to manufacture?
What factors are important for a multi-product facility?
How do you set limits for cleaning validation?
What do you need to consider when setting limits? What might be a limiting factor?
How would you validate a cleaning procedure? What's important from the analytical point of view?
What is a common acceptance level for carry-over in cleaning validation?
What is an easy method you could use for detection? What are its advantages and weaknesses?
You mentioned the drug, what about detergents?