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Does Q7A provide for the matrix approach to equipment cleaning validation, or are companies expected to perform a separate cleaning validation for each compound?

622 viewsOctober 10, 2022DrugsPharmaceutical
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Sam Smith11.38K January 5, 2021 0 Comments

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Blogolu28.38K Posted January 5, 2021 0 Comments

Yes. Section 12.7 states: “Validation of cleaning procedures should reflect actual equipment
usage patterns. If various APIs or intermediates are manufactured in the same equipment and the
same process cleans the equipment, a representative intermediate or API can be selected for
cleaning validation. This selection should be based on the solubility and difficulty of cleaning and
the calculation of residue limits based on potency, toxicity, and stability.”

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