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Questions and answers on the principles of GMP ... - Europa
material before sterile filtration and possible microbial growth during this hold time. Otherwise relevant provisions of chapter 9.5 “aseptic manufacturing” of the Part IV GMP guideline should be followed. The manufacturer should justify the applicability extent using …
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www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
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www.ema.europa.eusterile filtration in most cases is followed by at least one aseptic processing step such as filling. In order to focus on the most important aspect of filtration and aseptic processing at each section of this guideline, only one of the two steps may be mentioned, even if both steps are related.
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MODEL STANDARDS FOR PHARMACY COMPOUNDING …
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www.corning.com1 FILTRATION Selecting the Best Filter for Your Application Choosing a filter does not have to be complicated – Corning has simplified the process. Just follow these four easy steps: Step 1: Match your application with the appropriate pore size. Step 2: Select the membrane and housing material for your application. Step 3: Select the correct membrane area to optimize flow rate …