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pro vyhledávání: '"Harold S. Baseman"'
Autor:
Harold S. Baseman
One of the reasons aseptic processes are difficult to validate is that it involves trying to prove something has not happened. Aseptic process simulations, also referred to as media fills, are studies conducted on the aseptic filling process, which i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f63cdc4a272e11eaedc08f92cf0d88d0
https://doi.org/10.1016/b978-0-12-809412-9.00011-3
https://doi.org/10.1016/b978-0-12-809412-9.00011-3
Autor:
Harold S. Baseman, Igor Gorsky
The chapter describes Stage 2 of process validation–process performance qualification (PPQ). When design of the process is finalized, it is a time for commercialization of the process. General principles of the PPQ are discussed as they applied for
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c7a4d549f05548605c9fbe735281566b
https://doi.org/10.1016/b978-0-12-809412-9.00007-1
https://doi.org/10.1016/b978-0-12-809412-9.00007-1
Autor:
Igor Gorsky, Harold S. Baseman
Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, comp
Autor:
Harold S. Baseman, Michael Bogan
Publikováno v:
Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d52c04bc9e585639469d9f69d55a228a
https://doi.org/10.1002/9781118514399.ch7
https://doi.org/10.1002/9781118514399.ch7
Autor:
Harold S. Baseman, A. Hamid Mollah
Publikováno v:
Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. :1-15
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f1b879d4e9eccecfd31809f6b35c9ea8
https://doi.org/10.1002/9781118514399.ch1
https://doi.org/10.1002/9781118514399.ch1
Publikováno v:
PDA journal of pharmaceutical science and technology. 68(3)
Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc6a99b57b9bb945d9561268e293804b
https://pubmed.ncbi.nlm.nih.gov/25188348
https://pubmed.ncbi.nlm.nih.gov/25188348
Publikováno v:
Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing: Mollah/Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7bcb136201e8a22f44f8e6ac2a6ba84c
https://doi.org/10.1002/9781118514399
https://doi.org/10.1002/9781118514399