MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....elastomeric, plastic components or coatings of the container and closure system when in.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

CGMP Regulations
...Accelerated studies, combined with basic stability information on the components, drug products, and container-closure.....I) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit.....Such procedures shall also require appropriate retesting of any component, drug product container, or..
http://www.fda.gov/cder/dmpq/cgmpregs.htm (score=181)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a.....The design, composition, and quality control of the individual components of the container closure are key.....Skin temperature and moisture also influence the rate and extent of absorption of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=75)

Guidance For the Submission of Documentation for Sterilization Process
...The sensitivity of the experimental method used for container-closure integrity testing.....other processes should be addressed as each applies to the drug product,sterile packaging.....The sterilization and depyrogenation processes used for containers,closures, equipment..
http://www.fda.gov/cber/gdlns/sterval.pdf (score=36)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....The IND should describe the packaging and labeling used for the drug substance and the dosage.....The components for the closure and the closure design should be selected with due..
http://www.fda.gov/cder/guidance/package.htm (score=26)

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...chemical properties of the drug substance should be included in the application.Important.....elastomeric or plastic components of the container closure system.Examples of leachables are nitrosamines.....quality and reproducible performance of future batches of the drug substance.For additional..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=18)

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -...
...The assay of the drug substance in the container should be determined analytically with a stability indicating.....If possible, the results should be correlated with the extractables profiles of the container closure.....Moreover, interaction of the suspended drug substance with the various internal container..
http://www.fda.gov/cder/guidance/4234fnl.htm (score=18)

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