Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....All components and excipients for these products are rendered sterile,and release of the.....sterilize the product in its final container, it is critical that containers be filled and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=100)

Guidance for Industry
...In an aseptic process, the drug product, container, and closure are first subjected to.....All components and excipients for these products are rendered sterile,and release of the.....sterilize the product in its final container, it is critical that containers be filled and..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=99)

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...elastomeric or plastic components of the container closure system.Examples of leachables are nitrosamines.....All components of the container closure system that are responsible for metering,atomization, and delivery.....matter can originate during manufacturing, from formulation components,and from the container and closure..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=95)

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -...
...The dose is delivered by the integral pump components of the container closure system to the lungs by oral.....For the materials used in fabrication of the critical components of the container closure system, specific.....If possible, the results should be correlated with the extractables profiles of the container closure..
http://www.fda.gov/cder/guidance/4234fnl.htm (score=95)

MDI and DPI Drug Products
...elastomeric, plastic components or coatings of the container and closure system when in.....Documentation in Drug Applications for Container and Closure Systems Used for the.....recommended for inclusion in the application regarding the components, manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=35)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The design, composition, and quality control of the individual components of the container closure are key.....Interaction of the formulation with various container and closure components may contribute adversely to the.....In MDI products, the container closure system consists of the container, the valve and its components, the actuator..
http://www.fda.gov/cder/fdama/difconc.htm (score=34)

Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood...
...If a filter is attached to a blood container using aseptic technique but without an FDA.....Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for.....A device used to sterilely join blood tubing or segments without breaching container..
http://www.fda.gov/cber/gdlns/preleuk.htm (score=33)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...made to verify that the correct label has been affixed to the container and the shield.....evaluation can include testing of the material (see Section VI, Control of Components, 276.....how to conduct each test for components, in-process materials, and finished products. 1112..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=31)

CBER Compliance Program Guide - Inspection of Licensed and Unlicensed Blood...
...Reduction of the Maximum Platelet Storage Period to 5 Days in an Approved Container, June.....Blood and blood components intended for transfusion or for further manufacture into.....Blood and blood components intended for further manufacture that meet the device..
http://www.fda.gov/cber/cpg/7342001bld.htm (score=30)

FDA Recommendations Concerning Testing of Antibody to Hepatitis B Core...
...of Blood and Blood Components, negative anti-HBc test..results need not appear on-the.....anti-HBc screening of blood and blood components intended for..transfusion as a surrogate.....The container label of such an untested..product should include a statement such as the..
http://www.fda.gov/cber/bldmem/091091.pdf (score=30)

Guidance for Industry: Recognition and Use of a Standard for the Uniform...
...Standard will help facilitate the use of a uniform container label for blood and blood.....describes a system of uniform labeling for blood, blood components for transfusion, Source.....121(c)(13), the container label for blood and blood components may bear..encoded..
http://www.fda.gov/cber/gdlns/unilabbld.pdf (score=30)

Guidance for Industry - Recognition and Use of a Standard for the Uniform...
...0 Standard will help facilitate the use of a uniform container label for blood and blood components in the United States and.....0 Standard describes a system of uniform labeling for blood, blood components for.....121(c)(13), the container label for blood and blood components may bear encoded..
http://www.fda.gov/cber/gdlns/unilabbld.htm (score=30)

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