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)

Format and Content for the CMC Section of an Annual Report
...Regulatory specifications and analytical methods for the drug substance and drug..product.....during the reporting period, including immediate container labels, carton..labeling, and.....container and closure system to the original system in accordance..with compendial..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=84)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....The IND should describe the packaging and labeling used for the drug substance and the dosage.....The only way to be certain that a plastic substance is suitable for use as a container is..
http://www.fda.gov/cder/guidance/package.htm (score=247)

...A device that serves as a container for a drug or a device that is a drug delivery system attached to the drug container where the.....A device containing a drug substance as a component with the primary purpose of the combination.....drug by CDER. A device containing a drug substance as a component with the primary purpose of the combination product being to..
http://www.fda.gov/oc/ombudsman/drug-dev.htm (score=227)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....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=155)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....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=155)

...These regulations require documentation of the drug substance, drug product, placebo, labeling.....A description of the container/closure in which the botanical drug substance is to be.....A copy of the container label and the immediate outer carton label of the marketed product..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=124)

þÿ
...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....A description of the container closure system for the drug substance should be provided.....the suitability of the container closure systems should be provided in S.7.3 and..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=117)

þÿ
...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....A description of the container closure system for the drug substance should be provided.....the suitability of the container closure systems should be provided in S.7.3 and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=117)

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=108)

...In general, the drug substance and drug product specifications would be identical to or tighter.....In the past, applicants have used protocols for container closure system changes, and they.....htm or Division of Drug Information, HFD-240 Center for Drug Evaluation and Research 5600 Fishers Lane, Rockville, MD 20857..
http://www.fda.gov/cder/guidance/protcmc.doc (score=107)

Draft Guidance for Industry: Comparability Protocols — Chemistry,...
...If implementing a change using a comparability protocol calls for a revision of the drug product or drug.....In the past, applicants have used protocols for container closure system changes, and they.....as used in this guidance means drug substance, drug product, intermediate, or in-process..
http://www.fda.gov/cber/gdlns/cmprprot.htm (score=106)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale.....suppliers, container and closure systems, orientations of container during storage, drug.....The date placed on the container/labels of a drug product designating the time during..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=94)

GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS
...This is particularly important for the foreign sterile bulk drug substance manufacturer where.....Important aspects of the rigid container systems include moisture, particulates and.....In the preparation for a sterile bulk drug substance inspection, a flow chart with the major..
http://www.fda.gov/ora/inspect_ref/igs/subst.html (score=94)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a.....In addition, a product filler capable of reproducing an exact fill amount from container to container.....Skin temperature and moisture also influence the rate and extent of absorption of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=87)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling.....A description of the container/closure in which the botanical drug substance is to be.....A copy of the container label and the immediate outer carton label of the marketed product..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=84)

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.....A description of the container and closure system, and its compatibility with the drug..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=83)

Consistent Container Information in an Abbreviated Application
...The stability section only describes the container as made from"HDPE resin with a metal.....batch number and strength of the drug product used, the source of the active drug..substance.....To ensure that generic drug firms provide consistent descriptions of container..
http://www.fda.gov/cder/mapp/5225-2.pdf (score=83)

Chem Revs. of DMFs for DSIs
...Summarize the data showing that the container/closure system is compatible with the drug.....Include a description and acceptance tests for the container/closure system(s) components.....the bioavailability of the drug products made from the substance, including, for example,specifications relating to..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=83)

Microsoft Word - 5320.1.doc
...process and validation information for a sterile drug substance is the same as..for a sterile.....Container Closure System..Description of the container-closure system used for the drug.....Container Closure System..Description of the drug product container closure system [II.A.1..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=82)

Las Vegas Injury Lawyer