Lifecycle management in pharmaceutical analysis: How to establish an efficient and relevant continued performance monitoring program

Author:

Ermer Joachim,Aguiar Debora,Boden Annette,Ding Bei,Obeng Daniel,Rose Michael,Vokrot Julie

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference37 articles.

1. The application of quality by design to analytical methods;Borman;Pharm. Tech.,2007

2. Implications and opportunities of applying QbD principles to analytical measurements;Schweitzer;Pharm. Tech.,2010

3. Lifecycle management of analytical procedures: method development, procedure performance qualification, and procedure performance verification;Martin;Pharm. Forum,2013

4. Stimuli to the revision process: proposed new USP general chapter: the analytical procedure lifecycle ⟨1220⟩;Martin;Pharm. Forum,2017

5. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (Accessed November 2019) ICH Q8 (R2): Pharmaceutical Development (2009).

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