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Beschreibung
Quality cannot be assured only by doing finished product testing and in-process monitoring; it should be built into the manufacturing process. As a result, quality construction necessitates special attention to a few factors such as material selection, process design, control variables, in-process control, and finished product [...] this study, three initial batches of Clarithromycin tablets with the same size, method, equipment, and validation criteria were taken. Various critical parameters during dry mixing, wet granulation, drying, lubrication, and compression were identified and evaluated as per the validation protocol. The results of the whole process show that process validation data gives a high level of confidence that the manufacturing process will produce a product that meets its predetermined specification and quality attributes.
Quality cannot be assured only by doing finished product testing and in-process monitoring; it should be built into the manufacturing process. As a result, quality construction necessitates special attention to a few factors such as material selection, process design, control variables, in-process control, and finished product [...] this study, three initial batches of Clarithromycin tablets with the same size, method, equipment, and validation criteria were taken. Various critical parameters during dry mixing, wet granulation, drying, lubrication, and compression were identified and evaluated as per the validation protocol. The results of the whole process show that process validation data gives a high level of confidence that the manufacturing process will produce a product that meets its predetermined specification and quality attributes.
Über den Autor
Mrs. Ketaki ShindeM Pharm (QAT)LecturerShri Santkrupa Shikshan Sanstha`s College of Pharmacy, GhoganTq. Karad, Dist.- Satara, Maharashtra, India Specialization in Quality Assurance Techniques of pharmaceutical products.
Details
Erscheinungsjahr: | 2022 |
---|---|
Fachbereich: | Toxikologie |
Genre: | Importe, Medizin |
Rubrik: | Wissenschaften |
Medium: | Taschenbuch |
ISBN-13: | 9786138969624 |
ISBN-10: | 6138969626 |
Sprache: | Englisch |
Ausstattung / Beilage: | Paperback |
Einband: | Kartoniert / Broschiert |
Autor: |
Shinde, Ketaki
Doijad, R. Mulla, J. |
Hersteller: | Scholars' Press |
Verantwortliche Person für die EU: | preigu, Ansas Meyer, Lengericher Landstr. 19, D-49078 Osnabrück, mail@preigu.de |
Maße: | 220 x 150 x 9 mm |
Von/Mit: | Ketaki Shinde (u. a.) |
Erscheinungsdatum: | 25.04.2022 |
Gewicht: | 0,227 kg |
Über den Autor
Mrs. Ketaki ShindeM Pharm (QAT)LecturerShri Santkrupa Shikshan Sanstha`s College of Pharmacy, GhoganTq. Karad, Dist.- Satara, Maharashtra, India Specialization in Quality Assurance Techniques of pharmaceutical products.
Details
Erscheinungsjahr: | 2022 |
---|---|
Fachbereich: | Toxikologie |
Genre: | Importe, Medizin |
Rubrik: | Wissenschaften |
Medium: | Taschenbuch |
ISBN-13: | 9786138969624 |
ISBN-10: | 6138969626 |
Sprache: | Englisch |
Ausstattung / Beilage: | Paperback |
Einband: | Kartoniert / Broschiert |
Autor: |
Shinde, Ketaki
Doijad, R. Mulla, J. |
Hersteller: | Scholars' Press |
Verantwortliche Person für die EU: | preigu, Ansas Meyer, Lengericher Landstr. 19, D-49078 Osnabrück, mail@preigu.de |
Maße: | 220 x 150 x 9 mm |
Von/Mit: | Ketaki Shinde (u. a.) |
Erscheinungsdatum: | 25.04.2022 |
Gewicht: | 0,227 kg |
Sicherheitshinweis