
Title:
Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing
Author:
Roesti, David, 1973- editor.
ISBN:
9781119356110
9781119356196
Edition:
First edition.
Physical Description:
1 online resource
Contents:
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.
Abstract:
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.
Local Note:
John Wiley and Sons
Subject Term:
Genre:
Electronic Access:
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119356196Copies:
Available:*
Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 595619-1001 | RS403 | Searching... | Searching... |
