The regulatory framework for preventing cross-contamination of pharmaceutical products: History and considerations for the future

Author:

Sargent Edward V.,Flueckiger Andreas,Barle Ester Lovsin,Luo WendyORCID,Molnar Lance R.,Sandhu Reena,Weideman Patricia A.

Funder

Genentech Inc.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference66 articles.

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2. Public Health Assessment Guidance Manual;ATSDR,2015

3. Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for short-term clinical trials;Bercu;Regul. Toxicol. Pharmacol.,2013

4. Point of departure (PoD) selection for the derivation of acceptable daily exposure (ADE) values for active pharmaceutical ingredients (APIS);Bercu;Regul. Toxicol. Pharmacol.,2016

5. APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants;CEFIC,2014

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