GMP News: New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation

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The EMA just released a draft guideline on dedicated facilities and exposure limits for cleaning validation.

This link offers a synopsis of the content of the draft guideline. An excerpt:

“The draft Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, published in January had already been discussed conclusively by EMA’s Safety Working Party in December 2012. The new Guideline became necessary because of the more scientific approach of the Chapters 3 and 5 in the EU GMP Guideline. And the previous requirement for certain materials (“certain antibiotics, certain hormones, certain cytotoxic and certain highly active drugs”) to be manufactured in dedicated facilities was not very scientific without taking into consideration specific toxicological/pharmacological data. The same applies to the definition of the 1/1000 dosage or the 10 ppm criterion in the cleaning validation.” (continue reading here)

Read the draft Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.