Pre-use FIT

13:04 Jun 27, 2017

This question was closed without grading. Reason: Other

English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals

English term or phrase: Pre-use FIT

Supporting information, including an assessment of the potential quality risks associated with the proposed change, evaluation of filter validation and media fill simulations, as well as the results of development studies to demonstrate feasibility of the proposed change, are provided.
A post-approval notification or submission, as applicable, will be submitted to the Agency prior to implementation.
depicts both the current filtration process and the proposed redundant filtration process.
Figure 3.2.R.4-.
Overview of the Current and Proposed Filtration Process
Current step number and Process step
Current Filtration Process
Proposed Filtration Process
Proposed step number and Process step
Step 3:
Sterile Filtration
Manufacturing vessel
Manufacturing vessel
Step 3:
Filtration
Bioburden reducing filter
Bioburden
(

Maxim Polukhin KudoZ activity Questions: 8838 (2 open) (1 without valid answers) (739 closed without grading) Answers: 43
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Discussion entries: 3

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