Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....The components for the closure and the closure design should be selected with due.....If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier..
http://www.fda.gov/cder/guidance/package.htm (score=100)

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=31)

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=28)

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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