Cleaning Validation of different strengths of one substance like Amoxicillin

Under cleaning Validation , which are most suitable references that guide on how to select the worst case product among different strengths of the product e.g Amoxicillin 125mg, 250mg and 500mg tablets manufactured on the same production line.


WHO Technical Report Series, No. 937, 2006. Annex 4, Validation
4.1.4 Cleaning procedures for products and processes which are very similar do not need to be individually validated. A validation study of the “worst case” may be considered acceptable (bracketing)
4.1.6 Bracketing by product should be done only when the products concerned are similar in nature or property and will be processed using the same equipment. Identical cleaning procedures should then be used for these products.
4.1.7 When a representative product is chosen, this should be the one that is most difficult to clean. In your case, this would be the product of the highest concentration.

Thanks very for reply… i will regard your recommendations.

This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.