Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Igor Gorsky"'
Autor:
Igor Gorsky
This chapter will discuss Stage 3 of Process Validation Program—Continued Process Verification (CPV). First of all, it is important to understand regulation requirements that are behind the concept of continued verification of Critical Process Para
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::096ef3a7fe9cfdb704d833ae65f420e6
https://doi.org/10.1016/b978-0-12-809412-9.00008-3
https://doi.org/10.1016/b978-0-12-809412-9.00008-3
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
The chapter describes the use of statistics in process validation life cycle. Case studies and examples as well as use of statistical methods in designing the process, in process performance qualification and during continued process verification are
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f7ec2ab4453a25bd7d3a46a99ad33fd6
https://doi.org/10.1016/b978-0-12-809412-9.00005-8
https://doi.org/10.1016/b978-0-12-809412-9.00005-8
Autor:
Igor Gorsky
The primary aim of this chapter is to outline the significance of equipment cleaning as a process involving the development of cleaning procedures, their validation, and application. However, changes in an equipment cleaning process (ECP) are seldom
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2cca15d79ad8442ecbad2fa0c52d113d
https://doi.org/10.1016/b978-0-12-809412-9.00003-4
https://doi.org/10.1016/b978-0-12-809412-9.00003-4
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