Transcription of Cleaning Memo 2015-05
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Cleaning Memo 2015-05
Copyright 2015 by Cleaning Validation Technologies. This copyright protected Cleaning memo may beprinted for research, compliance and scientific purposes. Any other use, including downloading of the fileand including commercial distribution, is illegal and unethical. (May 2015 Cleaning memo )Page1of3 Cleaning memo for May 2015 EMA on Limits for Shared Facilities Part 3 This is the third in a series of Cleaning Memos discussing the finalized version of EMA s Guideline on setting health based exposure limits for use in risk identification in themanufacture of different medicinal products in shared facilities . It discusses still moreadditional specific issues in the November Gaps for Reproductive and Developmental ToxicityThe guideline refers to the possible lack of animal data on reproductive anddevelopmental toxicity (which I will just refer to as reproductive toxicity ), as well as gaps in the scientific knowledge for commercial products. One solution proposed is the NOAEL of a sub-chronic/chronic study may be used in the calculation of a PDEwith application of an additional adjustment factor ( 10) if adequately justified.
Copyright © 2015 by Cleaning Validation Technologies. This copyright protected Cleaning Memo may be printed for research, compliance and scientific purposes.
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