Validation Environment and Validation Planning

Author:

Vogel Patric U. B.

Publisher

Springer Fachmedien Wiesbaden

Reference7 articles.

1. Blasius H (2014) Arzneimittelherstellung Mehr als Produktion und Qualitätskontrolle. DAZ.online https://www.deutsche-apotheker-zeitung.de/daz-az/2014/daz-30-2014/arzneimittelherstellung. Accessed on: 10.08.2020.

2. Elroy J (2018) An introduction to analytical instrument qualification & validation – Meeting FDA expectations. https://www.pharmaceuticalonline.com/doc/an-introduction-to-analytical-instrument-qualification-validation-meeting-fda-expectations-0001. Accessed on: 10.08.2020.

3. EudraLex (2011) Volume 4 – Good Manufacturing Practice (GMP) guidelines Part I, chapter 4: Documentation. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2014-11_vol4_chapter_6.pdf. Accessed on: 12.08.2020.

4. Patel KT, Chotai NP (2011) Documentation and records: Harmonized GMP requirements. J Young Pharm 3:138–150. https://doi.org/10.4103/0975-1483.80303

5. Poveda C, Biter AB, Bottazzi ME et al. (2019) Establishing preferred product characterization for the evaluation of RNA vaccine antigens. Vaccines (Basel) 7:131. https://doi.org/10.3390/vaccines7040131

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