Cleaning Validation

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear all

in our manufacturing plant we have food supplement products and generic products (solid dosage) and all products produced at the same machines and i want to select the worst case product for cleaning validation and as we know the food supplement products have many actives (more than 10 elements) with very low concentration so how i can select the worst case product from these group? and potency , solubility and toxicity for every element in food supplement product must be calculated or not?

thanks for all

2

As a rule of thumb, selection of worst case product shall be based on sound and scientific justification. I would suggest you to tabulate all relevant products which are being produced by using the machine, with details such as API(s) of the products, potency, solubility, toxicity, therapeutic dose…etc. Then, you can have an overview of product and enable you to select worse case product for your cleaning validation.

Good luck!