Lyophilization Process
A Guide to Process Validation
Process validation is a requirement of the Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices. Lyophilization is an essential component of synthesis and formulation processes in chemical and pharmaceutical industry. Therefore, it is needed to be validation and per regulatory requirements. Successful process validation programs begin with a thoughtful and comprehensive corporate policy concerning the process validatio…
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Produktdetails
Weitere Autoren: Khunteta, Alok / Gupta, Manish K.
- ISBN: 978-3-659-78968-7
- EAN: 9783659789687
- Produktnummer: 37294921
- Verlag: LAP Lambert Academic Publishing
- Sprache: Englisch
- Erscheinungsjahr: 2019
- Seitenangabe: 96 S.
- Masse: H22.0 cm x B15.0 cm x D0.6 cm 161 g
- Abbildungen: Paperback
- Gewicht: 161
Über den Autor
Dr. S. K. Swarnkar, M. Pharm, PhD, is working as Assistant Professor at LBS College of Pharmacy, Jaipur, India. He is having more than 12 years of research and academic experiance.
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