Guidance 008 Cleaning Validation - Calculations of Residue Limits for Drug Product for

Equipment Cleaning
Acceptability Limits (RAL) should be calculated using the sum of product contact surface areas of
common equipment items/units between product A and B. Where there are more than one equipment train
configurations, the largest total surface area should be used in the RAL calculation. The manufacturing
and packaging area may be considered as separate equipment trains for RAL calculations. In the case of
stand-alone operations (operations that are not part of the routine manufacturing process and are used
only when necessary, e.g., sorting), the RAL should be calculated using the equipment item surface area.

Appendices: (Product names used in the examples are found commonly in the
market)

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Equipment Cleaning

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Equipment Cleaning

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Equipment Cleaning

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Equipment Cleaning

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