Inhaltsangabe
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.
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Über die Autorin bzw. den Autor
Anjali Sharma is presently working as Assistant Professor at Guru Gobind Singh College of Pharmacy. Her field of specialization is Pharmaceutics. She has 7 plus years of teaching experience.Devkant Sharma is presently working as Associate Professor at CH. Devi Lal College of Pharmacy, Yamunanagar. His field of specialization is Pharmaceutis.
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Process Validation of an Anticancer Drug
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Taschenbuch. Zustand: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 124 pp. Englisch. Bestandsnummer des Verkäufers 9786204979465
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Process Validation of an Anticancer Drug
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Zustand: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. 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, proc. Bestandsnummer des Verkäufers 661892802
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Process Validation of an Anticancer Drug
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Taschenbuch. Zustand: Neu. This item is printed on demand - Print on Demand Titel. Neuware -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.VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 124 pp. Englisch. Bestandsnummer des Verkäufers 9786204979465
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Taschenbuch. Zustand: Neu. Process Validation of an Anticancer Drug | Anjali Sharma (u. a.) | Taschenbuch | Englisch | 2022 | LAP LAMBERT Academic Publishing | EAN 9786204979465 | Verantwortliche Person für die EU: preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, mail[at]preigu[dot]de | Anbieter: preigu. Bestandsnummer des Verkäufers 122380768
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Process Validation of an Anticancer Drug
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LAP LAMBERT Academic Publishing, 2022
ISBN 10: 6204979469
ISBN 13: 9786204979465
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Taschenbuch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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. Bestandsnummer des Verkäufers 9786204979465
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