Cleaning validation

Production
1

Product A having 5 strengths there are 20mg,40mg,80mg,100mg and 120mg,in this which strengths consider for cleaning validation and why.

2

Please consider in your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:
- Drugs with higher toxicities
- Drugs with higher drug potencies
- Drugs of lower solubility in their cleaning solvents
- Drugs with characteristics that make them difficult to clean
- Swabbing locations for areas that are most difficult to clean
- Maximum hold times before cleaning
Based on above factors please identify the appropriate strength(s) of the product to be considered for cleaning validaton.

3

sir, please couuld explain about sanitize production area and filler area of bottled drinking water.

4

Boss here I am asking regarding OSD and Injectable products for examples: 1) Dasatinib tablets having different strengths (20,50,80,100,140mg) in this blend concentration is same for all strengths,but strength is changed from compression stage,and this product is worst case.which strength consider for cleaning validation. 2) Doxorubicin injection concentration is 2mg/ML and having strengths like 200mg/100ml and 50mg/25ml, which strength we consider for cleaning validation

5

  1. For Dasatinib (OSD) tablets the blend concentration is the same for the strenghts specified, therefore you may consider any strenghth, provided there is no change in master formula for further processing of tablets such as coating. Assumption is that the cleaning procedures are same for all strengths. Please ensure that the effiectiveness of equipment cleaning procedures is to be demonstrated on consecutive 3 batches of the SAME selected strength of this product.

  2. For Doxorubicin injection the strengths specified by you are of same concentration. Therefore, you may consider any strength provided the master formula of all strenghts is the same. Please ensure that the effiectiveness of equipment cleaning procedures is to be demonstrated on consecutive 3 batches of the SAME selected strength of this product. (If master formulae of these strengths are different then you will have to consider individual strenghts for identifying “Worst cases” scenario.

Please ensure that all the aspects are complied (as worst cases) for these products which I had specified in my previous communication.

6

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