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=94)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....The composition of the formulation of a DPI has a direct effect on the stability of the.....The appearance of the content of the container and the appearance of the container and..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=83)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....The composition of the formulation of a DPI has a direct effect on the stability of the.....The appearance of the content of the container and the appearance of the container and..
http://www.fda.gov/cder/guidance/2180dft.htm (score=83)

þÿ
...formulation, container closure system, manufacturing,stability, controls of critical steps.....matter can originate during manufacturing, from formulation components,and from the.....and components are used for reproducible delivery of drug formulation,and these can be..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=81)

Animal Drug Manufacturing Guidelines
...formulation, container-closure system, manufacturing process, source and quality of bulk.....These facilities may be used in formulation development work or other developmental.....Data on the product stored in the proposed container-closure for marketing under storage..
http://www.fda.gov/CVM/guidance/admguideline.html (score=81)

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -...
...formulation, container closure system, manufacturing, stability, controls of critical steps.....The formulation and container closure system components of the three primary stability batches should be.....Nasal spray drug products should include acceptance criteria for net content of the formulation in the..
http://www.fda.gov/cder/guidance/4234fnl.htm (score=81)

...Container and Closure System Nasal aerosols usually consist of the formulation, container, valve.....Similarly, nasal sprays usually consist of the formulation, container, pump, actuator, protection cap.....Suspension Formulation Nasal Sprays We recommend BA of lower strength suspension..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=81)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...Nasal aerosols consist of the formulation, container, valve, actuator, dust cap.....Similarly, nasal sprays consist of the formulation, container, pump, actuator, protection.....For an ANDA of a suspension formulation, the PSD of the active drug in the dosage form..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=81)

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)

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...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)

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