Subjects: Quality Control - Digital Collections - National Library of Medicine Search Results

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21. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Drug Industry
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

22. Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Chemistry, Pharmaceutical
Genetic Therapy
Investigational New Drug Application
Drugs, Investigational
Quality Control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. Q3D(R1) elemental impurities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Drug Contamination -- prevention & control
Quality Control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

24. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Chromatography -- standards
Drug Approval
Quality Control
Reference Standards
Calibration
Chemistry Techniques, Analytical
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

25. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, September 2019
Subject(s):: Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

26. Considerations for the development of dried plasma products intended for transfusion

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019
Subject(s):: Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. Most hospitals obtain compounded drugs from outsourcing facilities, which must meet FDA quality standards

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2019
Subject(s):: Drug Compounding -- standards
Medicare
Outsourced Services
Purchasing, Hospital
Quality Control
Chemistry, Pharmaceutical -- standards
Humans
United States
United States. Food and Drug Administration.

28. CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):: Drug Industry
Government Regulation
Quality Control
Reference Standards
United States
United States. Food and Drug Administration

29. Review of Medicare administrative contractor information security program evaluations for fiscal year 2022

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
Subject(s):: Computer Security -- standards
Government Regulation
Medicare -- organization & administration
Quality Control
United States