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Sterilization Drugs United States
1
E-Books/E-Docs
 

Guidance for industry sterile drug products produced by aseptic processing, current good manufacturi



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:ST 3    ---  Available
2
E-Books/E-Docs
 

Guidance for industry submission of documentation in applications for parametric release of human an



Silver, Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Veterinary Medicine : Center for Biologics Evaluation and Research, [2008] 2008

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:P 21    ---  Available
3
E-Books/E-Docs
 

Guidance for industry submission of documentation in applications for parametric release of human an



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2010] 2010

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:P 21    ---  Available
4
E-Books/E-Docs
 

Guidance for industry for the submission documentation for sterilization process validation in appli



[Rockville, MD] : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [1994] 1994

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:ST 4/2    ---  Available
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