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Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing
- Available as
- Online
Details
- Creator
- edited by David Roesti, Marcel Goverde
- Format
- Books
- Language
- English
- Contributors
- Publication
-
- First edition
- Hoboken, NJ : Wiley, 2019
- Physical Details
-
- 1 online resource
- data file
- ISBNs
- 9781119356110, 1119356113, 9781119356196, 1119356199, 9781119356073, 1119356075, 9781119356073, 1119356075
- OCLC
- on1127947568
- 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