MDI and DPI Drug Products
...container and closure system as a result of direct contact with the formulation of the MDI.....an internal reservoir containing sufficient formulation for multiple doses that are.....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...
...MDI products are unique with respect to formulation, container, closure, manufacturing, in-process.....As discussed above, the composition of an DPI formulation and container closure system are crucial in.....As discussed previously, the composition of an MDI formulation and the container closure system are crucial in..
http://www.fda.gov/cder/fdama/difconc.htm (score=36)

Acidified food manufacturers
...Are container examinations made as per the container manufacturer specifications and or.....Formulation control would have to include consideration of such things as raw material pH.....The product formulation should be developed to assure that the finished equilibrium pH is..
http://www.fda.gov/ora/inspect_ref/igs/acidfgde.htm (score=30)

þÿ
...formulation components or leaching from the container closure system, chemical impurities.....packaged in semipermeable primary container closure systems, such as low-density.....practicable, the leaching and entry of chemical contaminants into the drug formulation. 94..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=30)

...area, fills 2 the container, and it withdraws, and then the 3 container is sealed and.....There are many more 19 proprietary chemicals used in the formulation of 20 these adhesives.....12 So, in a nutshell, product contamination 13 can occur because of the formulation..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=30)

stability guidance -draft
...Additionally, compatibility of the preservative system with the container, closure.....should be representative in all respects such as formulation, manufacturing site.....the same formulation of the dosage form in the container and closure proposed for..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=29)

Liquid Chemical Sterilants
...a change in the chemical composition of the germicide formulation, such as addition of a.....single container germicide or a germicide with separate buffer and activator containers.....Therefore, stability studies should address the real time stability and dynamics of the..
http://www.fda.gov/cdrh/ode/lcgguide.html (score=28)

þÿ
...formulation components or leaching from the container closure system, chemical impurities.....packaged in semipermeable primary container closure systems, such as low-density.....practicable, the leaching and entry of chemical contaminants into the drug formulation. 94..
http://www.fda.gov/cder/guidance/4168dft.PDF (score=27)

Format and Content for the CMC Section of an Annual Report
...during the reporting period, including immediate container labels, carton..labeling, and.....Formulation [21 CFR 314.70(d)(4)] Deletion of an ingredient intended only to affect the.....container and closure system to the original system in accordance..with compendial..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=27)

...CONTAINER BODY AND SEALS FROM DAMAGE THAT COULD RESULT| |22 |IN LEAKAGE AND POST PROCESS.....For example, a change in the | | |formulation such as size of solid pieces, the solid to.....ARE PRODUCTS ACIDIFIED ACCORDING TO THE METHOD AND/OR FORMULATION | | |SPECIFIED IN THE..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511-2.DOC (score=26)

Document
...recommendation for a formulation.. be extended to May 22, 2002. SUMMARY: The IRS is.....wrapper is also the only container or .. Todd A. Stevenson, other designation that relates.....including each outer container or .. relying on the voluntary standard. rulemaking..
http://www.fda.gov/OHRMS/DOCKETS/98fr/042402a.pdf (score=26)

/a/content.2223
...involving the sustained-release formulation of bupropion resulted from the different.....This supplement provides for revisions to the immediate container labeling for the 100 mg.....immediate-release formulation of bupropion at 100 mg three times daily, peak plasma..
http://www.fda.gov/cder/ogd/rld/20358s16.pdf (score=31)

Packaging
...A suitable closure is an essential part of the container/closure system required to.....The identity of the source and a description of the formulation(s), process(es), and.....Thus, the container characteristics and tests and specifications are reviewed in the..
http://www.fda.gov/cder/guidance/package.htm (score=28)

Variations in Drug Products that May be included in a Single A
...In this case,the studies are not related to a difference in formulation but have been.....Except for pharmacy bulk packages, products utilizing different container sizes.....application if two strengths of a capsule have differences in formulation or if there..are..
http://www.fda.gov/cder/guidance/2090fnl.pdf (score=27)

Guidance for Industry
...Direct inoculation into the drug formulation provides an assessment of the effect of drug.....In an aseptic process, the drug product, container, and closure are first subjected to.....product cannot be filter sterilyzed, and, therefore, each component in the formulation..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=27)

20924LBL.PDF
...When multiples of the formulation are used for more than a few weeks,Vitamins A and D.....fat soluble vitamins to solubilize in one container. The lyophilization of CernevitTM-12.....This formulation is indicated as a daily multivitamin maintenance dosage for adults and..
http://www.fda.gov/cder/foi/LABEL/1999/20924lbl.pdf (score=27)

Guidance for Industry
...Direct inoculation into the drug formulation provides an assessment of the effect of drug.....In an aseptic process, the drug product, container, and closure are first subjected to.....product cannot be filter sterilyzed, and, therefore, each component in the formulation..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=27)

...4 Container Closure System The choice and rationale for selection of the container closure.....1 Formulation Development A summary should be provided describing the development of the.....1 Formulation Development 6 2.2.2 Overages 6 2.2.3 Physicochemical and Biological..
http://www.fda.gov/cder/guidance/6672dft.doc (score=27)

ICH; Draft Guidance on Q8 Pharmaceutical Development
...Changes in formulation and manufacturing processes during development should be looked.....the properties of the drug substance, excipients, container closure system, any relevant.....These critical formulation attributes and process parameters are generally identified..
http://www.fda.gov/cber/gdlns/ichq8pharm.htm (score=26)

...ARE CONTAINER HANDLING PROCEDURES AND CONVEYANCE EQUIPMENT ADEQUATE TO | |58 |PROTECT THE.....EMPTY CONTAINER INTEGRITY | |25 |DESCRIBE THE CONTAINERS BEING USED DURING THIS INSPECTION.....DOES THE FIRM HAVE WRITTEN CRITERIA TO ACCEPT OR REJECT INCOMING EMPTY | |27 |CONTAINER..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511.DOC (score=26)

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