MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....container and closure system as a result of direct contact with the formulation of the MDI.....Documentation in Drug Applications for Container and Closure Systems Used for the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A sophisticated formulation of the drug product is required to ensure dosing accuracy and reproducibility, and.....MDI products are unique with respect to formulation, container, closure, manufacturing, in-process.....A sophisticated formulation of the drug product is required to ensure dosing accuracy and reproducibility, and the..
http://www.fda.gov/cder/fdama/difconc.htm (score=65)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....Such a correlation may obviate the need to evaluate leachables in the drug product formulation in..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=55)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....Such a correlation may obviate the need to evaluate leachables in the drug product formulation in..
http://www.fda.gov/cder/guidance/2180dft.htm (score=55)

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...drug product should be indicated for each container fill weight.Qualifying terms such as at.....and components are used for reproducible delivery of drug formulation,and these can be.....formulation, container closure system, manufacturing,stability, controls of critical steps..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=50)

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -...
...spray patterns from pumps with drug product formulation and with the proposed simulating media are the.....The number of medication sprays expected throughout the shelf life of the drug product should be indicated for each container fill.....formulation, container closure system, manufacturing, stability, controls of critical steps..
http://www.fda.gov/cder/guidance/4234fnl.htm (score=50)

...Release of the drug from the drug product produces droplet or drug particle sizes and distribution patterns.....Container and Closure System Nasal aerosols usually consist of the formulation, container, valve.....From a product quality perspective, the critical issues are release of drug substance from drug product and..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=50)

Animal Drug Manufacturing Guidelines
...Whether drug products are sterilized by terminal sterilization, or whether parts of the drug.....formulation, container-closure system, manufacturing process, source and quality of bulk.....One test batch of drug product should be manufactured to support alternate manufacturing sites..
http://www.fda.gov/CVM/guidance/admguideline.html (score=49)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...information that pertains to the identity, strength,quality, purity, and potency of a drug.....Nasal aerosols consist of the formulation, container, valve, actuator, dust cap.....affect the BA of the drug product as a result of different solubilities and/or rates of..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=49)

Guideline for Submitting Supporting Documentation
...Approval of reprocessing procedures must be obtained before release of the reprocessed drug or drug.....An amendment should be filed for any significant changes in formulation not proposed in.....Information relating to the container, closure, stability, and labeling are discussed in..
http://www.fda.gov/cder/guidance/drugprod.htm (score=44)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....Direct inoculation into the drug formulation provides an assessment of the effect of drug.....could increase the potential for introducing contaminants to exposed product, container-closures..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=43)

...20 Ingress or leaching of such chemicals into 21 drug product formulation poses a safety concern for 22.....area, fills 2 the container, and it withdraws, and then the 3 container is sealed and.....This increases the likelihood for 6 administration of the wrong drug product by the 7 wrong..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=41)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....Direct inoculation into the drug formulation provides an assessment of the effect of drug.....could increase the potential for introducing contaminants to exposed product, container-closures..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=41)

stability guidance -draft
...Historically, all changes in drug product formulation were grouped together and required.....The date placed on the container/labels of a drug product designating the time during.....Additionally, compatibility of the preservative system with the container, closure..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=41)

Sterile Drug Products Produced by Aseptic Processing
...In an aseptic process, the drug product, container, and closure are first subjected to sterilization.....The sterile drug product and its container-closures should be protected by equipment of.....formulation processing stage.  The total time for product filtration should be limited to..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=40)

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...system components are critical to ensure the quality and purity of the drug product and must be.....formulation components or leaching from the container closure system, chemical impurities.....environment, particularly the secondary packaging, can react with the drug product to form..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=40)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....It is also possible for a component of the drug product to migrate through the walls of the.....The identity of the source and a description of the formulation(s), process(es), and..
http://www.fda.gov/cder/guidance/package.htm (score=39)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....accelerator operation, radiochemical synthesis, purification steps, and formulation of the.....made to verify that the correct label has been affixed to the container and the shield..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=38)

Validation of Chromatographic Methods
...both drug substance and drug product.Detection limit is the lowest concentration of analyte in a sample that.....solution to complex cream formulation, and from potential adhesion to..container/closure.....The components monitored include chiral or achiral drug, process impurities,residual..
http://www.fda.gov/cder/guidance/cmc3.pdf (score=34)

FR Doc 04-4249
...For example, if an OTC drug manufacturer made and sold a particular drug product, that drug product would have a.....Alternatively, it may be possible to modify the drug's immediate container to accommodate a label bearing a.....formulation changes to their drugs and create logistical complications for retailers..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm (score=34)

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