Guidance for Industry
...products shall be excluded from direct contact with components, drug product containers, closures, in.....also require appropriate retesting of any component, drug product container, or closure that is subject.....prevent the contamination of equipment, components, drug product containers, closures..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=100)

Guidance for Industry
...products shall be excluded from direct contact with components, drug product containers, closures, in.....also require appropriate retesting of any component, drug product container, or closure that is subject.....prevent the contamination of equipment, components, drug product containers, closures..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=99)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....elastomeric, plastic components or coatings of the container and closure system when in.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=88)

Sterile Drug Products Produced by Aseptic Processing
...Any manual or mechanical manipulation of the sterilized drug, components, containers, or.....In an aseptic process, the drug product, container, and closure are first subjected to sterilization.....Drug product components, containers, closures, storage time limitations, and manufacturing equipment..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=84)

FR 9/30/97 Natural Rubber-Containing Medical Devices; User Labeling
...Combination products that have device and drug components but are regulated under drug.....Device container vials with dry natural rubber stoppers, when used in combination with a.....Combination products that have device and biological components, but that are regulated..
http://www.fda.gov/cdrh/dsma/fr93097.html (score=81)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....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..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=29)

GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURER'S - CGMPR'S
...Determine the validity, and accuracy of the firm's inventory system for drug components.....The label should identify the contents of the container or equipment including the batch.....Components must be handled in accordance with the drug CGMP's including components used in the research and..
http://www.fda.gov/ora/inspect_ref/igs/dose.html (score=140)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...If one or more of the approved drug components is covered by a patent, the FDA could not.....container, since polymer/foil blisters are not as impervious to moisture as high-density.....This evaluation provides the link between the new combination drug product and the drug products whose safety..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=139)

Guidance for Industry
...link between the new combination drug product and the drug products whose safety, efficacy.....and may be especially important if the product is to be packaged in a blister container.....Applicants should consider differences in food instructions between individual components..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf (score=138)

July/August 2001 FDA Veterinarian Newsletter
...If you store dry pet food in a container other than its original bag, be sure to wash the.....The NARMS program plays an important role in the overall understanding of antimicrobial.....drug components; failure to have adequate clean-out procedures for all equipment in the..
http://www.fda.gov/cvm/index/fdavet/2001/Jul_Aug.htm (score=82)

Document
...administering the drug at the wrong manufacture, processing, and packing of components.....the outside container or wrapper (see 68 the time the drug is administered. at the unit.....and blood components. bar coding standard for blood and blood components to contain, at a..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=82)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A multistage cascade impactor fractionates and collects particles of one or more drug.....The design, composition, and quality control of the individual components of the container and the closure.....Preferential interaction of the suspended drug substance with the various internal..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=80)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A multistage cascade impactor fractionates and collects particles of one or more drug.....The design, composition, and quality control of the individual components of the container and the closure.....Preferential interaction of the suspended drug substance with the various internal..
http://www.fda.gov/cder/guidance/2180dft.htm (score=80)

...A device that serves as a container for a drug or a device that is a drug delivery system attached to the drug container where the.....Device manufacturers must assure that manufacturing steps do not adversely affect drug.....container is a combination product that will be regulated as a drug by CDER. A device..
http://www.fda.gov/oc/ombudsman/drug-dev.htm (score=79)

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.....For plastic components, there is the potential for drug adsorption into the plastic, swelling of the plastic, and leaching of.....These components affect the release rate of the drug and the adherence of the device to the skin and, therefore, have a large impact..
http://www.fda.gov/cder/fdama/difconc.htm (score=29)

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