Home » Pharmaceutical Microbiological Quality Assurance and Control
Product Image

Pharmaceutical Microbiological Quality Assurance and Control

€192.14
Quantity:
Ships in 10-20 days
Delivery/Collection within 10-20 working days
Shipping & Delivery
advancements provides guidance
Age Group_Uncategorized
Age Group_Uncategorized
automatic-update
B01=David Roesti
B01=Marcel Goverde
Category1=Non-Fiction
Category=PS
COP=United States
Delivery_Delivery within 10-20 working days
eq_bestseller
eq_isMigrated=2
eq_nobargain
eq_non-fiction
eq_science
Language_English
microbiological laboratory personnel
microbiology quality assurance
non-filterable drug products
non-sterile pharmaceuticals
non-sterile pharmaceuticals manufacturing
PA=Available
Price_€100 and above
PS=Active
risk mitigation strategies
softlaunch

Product details

  • ISBN 9781119356073
  • Weight: 1043g
  • Dimensions: 160 x 231mm
  • Publication Date: 23 Jan 2020
  • Publisher: John Wiley & Sons Inc
  • Publication City/Country: US
  • Product Form: Hardback
  • Language: English
Secure checkout Fast Shipping Easy returns
Description

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

  • Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC
  • Presents the latest developments in both regulatory expectations and technical advancements
  • Provides guidance on statistical tools for risk assessment and trending of microbiological data
  • Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
About

David Roesti, PhD, works at Novartis Pharma AG in Stein, Switzerland, and is responsible for defining the microbial control strategy at the site and is a global subject matter expert in microbiology for the Novartis group. He is also is an elected member of the General Chapters Microbiology Expert Committee of the Unites States Pharmacopoeia 2015–2020 revision cycle.

Marcel Goverde, PhD, runs MGP Consulting GmbH for consulting, training and project management in GMP-relevant areas with a focus on microbiology, hygiene and deviation management. He is the Swiss expert in the EDQM group for Modern Microbiological Methods since 2003, which was then integrated into Group 1 (Microbiological Methods and Statistical Analysis) in 2015.