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)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....The date placed on the container/labels of a drug product designating the time during.....suppliers, container and closure systems, orientations of container during storage, drug..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=113)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with.....A description of the container and closure system, and its compatibility with the drug.....trials materials and commercial production batches of drug substance and drug product should be..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=84)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=76)

...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....A description of the container/closure in which the botanical drug substance is to be.....one in which the components or ingredients and composition of the drug substance and drug product are kept..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=75)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....18 The applicant and/or drug product manufacturer must establish the reliability of the.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=74)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....A description of the container/closure in which the botanical drug substance is to be.....one in which the components or ingredients and composition of the drug substance and drug product are kept..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=72)

Microsoft Word - 5320.1.doc
...6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are.....Container Closure System..Description of the container-closure system used for the drug.....Description of the Composition of the Drug Product..Description of the drug product composition..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=58)

Microsoft Word - 5020.1.doc
...6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are.....Container Closure System..Description of the container-closure system used for the drug.....Description of the Composition of the Drug Product..Description of the drug product composition..
http://www.fda.gov/cder/mapp/5020.1.pdf (score=58)

Validation of Chromatographic Methods
...both drug substance and drug product.Detection limit is the lowest concentration of analyte in.....and leachables from container and closure or manufacturing process, pesticide in drug.....Solution stability of the drug substance or drug product after preparation..according to the..
http://www.fda.gov/cder/guidance/cmc3.pdf (score=51)

Guideline for Submitting Supporting Documentation
...Approval of reprocessing procedures must be obtained before release of the reprocessed drug or drug.....Contract laboratories performing quality control tests on raw materials, drug substance, or the.....Information relating to the container, closure, stability, and labeling are discussed in..
http://www.fda.gov/cder/guidance/drugprod.htm (score=44)

Q1B Photostability Testing of New Drug Substances and Products
...If testing of the drug product in the immediate container or as marketed is needed, the samples should be placed.....This testing may involve the drug substance alone and/or in simple solutions/suspensions to.....Normally, only one batch of drug substance is tested during the development phase, and then the..
http://www.fda.gov/cder/guidance/1318.htm (score=44)

Microsoft Word - 5040.1.doc
...6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are.....Container Closure System..Description of the container-closure system used for the drug.....Description of the Composition of the Drug Product..Description of the drug product composition..
http://www.fda.gov/cder/mapp/5040.1.pdf (score=36)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....In the past, applicants have used protocols for container closure system changes, and they.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=34)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...Related substances are defined as those structurally related to a drug substance such as a degradation product or impurities.....container, or is transported without containerization to a location for subsequent.....The USP also notes that the impurity profile of a drug substance is a description of the..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=32)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....In the past, applicants have used protocols for container closure system changes, and they.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=31)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...If drug substance and drug product information is provided in an appendix, the preferred presentation is drug.....Miscellaneous drug product impurities include, for example, container closure system leachables, excipient degradants, heavy metals.....For solutions, the concentration of the drug substance in the drug product should be compared..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=31)

Supplements and Other Changes to an Approved Application; Final Rule
...In addition, as a result of comments requesting that the use of the terms drug, drug product, drug substance, and.....Where a drug product container closure system controls drug delivery, FDA requires information to be.....The comments said that to include items beyond the drug substance and drug product represents a..
http://www.fda.gov/cber/rules/suppapp.htm (score=28)

ANNEX E Glossary of Terms
...any substance represented for use in a drug and when in the manufacturing, processing, or packaging of a drug becomes an.....The term also includes repackaging or otherwise changing the container, wrapper, or.....establishment which affixes the original label to a product or changes in any way the..
http://www.fda.gov/cder/drls/annexe.htm (score=21)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....The IND should describe the packaging and labeling used for the drug substance and the dosage.....It is also possible for a component of the drug product to migrate through the walls of the container, and oxygen, carbon dioxide, or..
http://www.fda.gov/cder/guidance/package.htm (score=21)

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