Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing
by
Roesti, David, 1973- editor.
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
:
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
Genre
:
Electronic books.
Added Author
:
Roesti, David, 1973-
Goverde, Marcel, 1967-
Electronic Access
:
| Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
|---|
| Online Library | E-Book | 595619-1001 | RS403 | | Wiley E-Kitap Koleksiyonu |