Process Validation of an Anticancer Drug - Couverture souple

Sharma, Anjali; Sharma, Devkant

Couverture souple

ISBN 10 : 6204979469 ISBN 13 : 9786204979465

Editeur : LAP LAMBERT Academic Publishing, 2022

Synopsis

The process validation of dosage form is one of the most important regulatory requirements for pharmaceutical industry. It shows the documented evidence about the quality of the product by validating the whole manufacturing process. According to USFDA, process validation is the collection and evaluation of data, from the design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality attributes. The aim of current study was to prospectively validate the manufacturing process of tablets of drug X and assure that product meets predetermined specifications and quality attributes as per FDA and cGMP requirements. To achieve the said goal, a robust validation protocol was designed wherein critical process parameters were identified. Certain routine in-process evaluation tests and challenge studies were performed. Also tests on finished product were executed.

Détails de l'édition

• Éditeur: LAP LAMBERT Academic Publishing
• Date d'édition: 2022
• Langue: anglais
• ISBN 10: 6204979469
• ISBN 13: 9786204979465
• Reliure: Broché
• Nombre de pages: 124
• Coordonnées du fabricant: non disponible
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