Niazi | Handbook of Pharmaceutical Manufacturing Formulations | Buch | 978-1-4200-8130-5 | www.sack.de

Buch, Englisch, 464 Seiten, Format (B × H): 223 mm x 286 mm, Gewicht: 2720 g

Niazi

Handbook of Pharmaceutical Manufacturing Formulations

Sterile Products
2. New Auflage 2009
ISBN: 978-1-4200-8130-5
Verlag: Taylor & Francis Inc

Sterile Products

Buch, Englisch, 464 Seiten, Format (B × H): 223 mm x 286 mm, Gewicht: 2720 g

ISBN: 978-1-4200-8130-5
Verlag: Taylor & Francis Inc

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.
Highlights from Sterile Products, VolumeSix include:

formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications
specifications of a manufacturing facility to manufacture compliant sterile products
NDA or aNDA filing requirements of sterile products
an alphabetical presentation of formulations of pharmaceutical products based on their generic names

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Zielgruppe

Pharmaceutical manufacturers, and quality assurance and production personnel.

Autoren/Hrsg.

Niazi, Sarfaraz K.
Niazi, Safaraz K.

Fachgebiete

Weitere Infos & Material

REGULATORY AND MANUFACTURINGSterile Manufacturing Formulations TemplateGMP Audit Template, EU GuidelinesInspection of Sterile Product Manufacturing FacilitiesNew Drug Application for Sterilized ProductsValidation of Cleaning ProcessViral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginAnalysis of the Expression Construct in Cells Used for Production of rDNA-Derived Protein ProductsStability Testing of Biotechnological/Biological ProductsDerivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsComparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing ProcessSpecifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsEssential Clean-Room Design ElementsApproved Excipients in Sterile Dosage FormsMANUFACTURING FORMULATIONSSterile Products

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