Cleaning validation

Sir if company are manufacturing third party products means lots of product approx 600-700. So there is not possible to select the worst case. So that case how we Will be select the worst case of products.

Please consider the following important aspects while performing Cleaning validation studies of different products being manufactured in the common/shared facility.
Design the 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:

o Drugs with higher toxicities
o Drugs with higher drug potencies
o Drugs of lower solubility in their cleaning solvents
o Drugs with characteristics that make them difficult to clean
o Swabbing locations for areas that are most difficult to clean
o Maximum hold times before cleaning (Establish dirty equipment hold-time)
  • In addition, please consider the steps that must be taken in your change management system SOP before the introduction of new manufacturing equipment or a new product.

  • SOP should be in place that ensures an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.

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sir how we will prepare product matrix for selection of worst case. Because 500-600 products being manufacturer. So it is necessary to identify and evaluation of every product for worst case.

You can select only active products which are manufactured and group them molecule-wise (all strengths of one molecule together). Then you can apply strategy as per my previous answer.

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

In addition, please consider the steps that must be taken in your change management system SOP before the introduction of new manufacturing equipment or a new product from your list.

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sir which guidelines is use for cleaning validation.

You may use USFDA guidelines or any equivalent guidelines.

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Thanku sir

You are always welcome.