Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing
tarafından
 
Roesti, David, 1973- editor.

Başlık
Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing

Yazar
Roesti, David, 1973- editor.

ISBN
9781119356110
 
9781119356196

Basım Bilgisi
First edition.

Fiziksel Tanımlama
1 online resource

İçerik
Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced.

Özet
Relying on practical examples from the authors experience, this comprehensive book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. -- Edited summary from book.

Notlar
John Wiley and Sons

Konu Terimleri
Pharmaceutical chemistry.
 
Drugs -- Testing.
 
Electronic books.
 
Chemistry, Pharmaceutical
 
Chimie pharmaceutique.
 
Médicaments -- Essais cliniques.
 
Livres numériques.
 
e-books.
 
Quality Control.
 
Analytic.
 
Chemistry.
 
SCIENCE.
 
Microbiology.
 
Life Sciences.
 
TECHNOLOGY & ENGINEERING.
 
Drugs -- Testing
 
Pharmaceutical chemistry

Tür
Electronic books.

Yazar Ek Girişi
Roesti, David, 1973-
 
Goverde, Marcel, 1967-

Elektronik Erişim
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119356196


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