Provides an overall view of designing cleaning programs in pharmaceutical process manufacturing settings, establishing residue limits, and selecting appropriate sampling and analytical procedures. Most of the examples given in the book involve simple cleaning systems, such as th…
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 no…
"This book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. It covers state-of-the-art microbiology quality assurance and control (QA / QC) tests as well as risk mitigation str…
Pharmaceutical quality systems