GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS
...This is particularly important for the foreign sterile bulk drug substance manufacturer where.....In the preparation for a sterile bulk drug substance inspection, a flow chart with the major.....Conversion of the non-sterile drug substance to the sterile form by dissolving in a solvent..
http://www.fda.gov/ora/inspect_ref/igs/subst.html (score=100)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale.....process of a drug substance or drug product is made, sufficient data to show that such a change.....That constituent of the packaging that is in direct contact with the drug substance or drug..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=95)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....of each facility involved in the manufacturing of the drug substance and excipients should.....The guidance sets forth information that should be provided to ensure continuing drug..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=81)

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.....trials materials and commercial production batches of drug substance and drug product should be.....This section should be completed for each drug substance identified as being present in the..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=69)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....Safety studies should provide a comparison of results of safety testing of the drug product or drug substance.....Impurities present in the new drug substance need not be monitored in drug products unless they..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=64)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q.....recommends that the drug substance information be included in a master file or incorporated in..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=62)

...These regulations require documentation of the drug substance, drug product, placebo, labeling.....one in which the components or ingredients and composition of the drug substance and drug.....Batch-to-batch consistency should be demonstrated for the botanical drug substance and drug..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=59)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q.....recommends that the drug substance information be included in a master file or incorporated in..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=59)

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.....Skin temperature and moisture also influence the rate and extent of absorption of the drug.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can..
http://www.fda.gov/cder/fdama/difconc.htm (score=59)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling.....one in which the components or ingredients and composition of the drug substance and drug.....CMC information on a botanical raw material, drug substance, and/or drug product may be..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=57)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....Production of a drug substance, whether by synthesis, fermentation, or isolation, usually.....the NDA for the new drug substance, as well as the limits for impurities, should be based on..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=57)

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug...
...2 The term drug substance, which is used throughout the text, is intended to include biological.....the potential impact on the biological safety, quality, and purity of the drug substance and/or.....A major use of mAb reagents is in the purification of drug substance by mAbs attached to a..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=52)

Chem Revs. of DMFs for DSIs
...Summarize the data showing that the container/closure system is compatible with the drug.....the bioavailability of the drug products made from the substance, including, for example,specifications relating to.....Describe any reprocessing or re-working done during the preparation of the drug substance..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=50)

Content and Format of INDs for Phase 1 Studies of Drugs, Inclu
...Food and Drug Administration, Center for Drug Evaluation and Research,"IND Process and.....of the IND to demonstrate that the new drug substance and drug product..are within acceptable.....drug substance and dosage form, and even changes in the dosage form..itself, are likely as the..
http://www.fda.gov/cder/guidance/clin2.pdf (score=45)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the.....drug substance and drug product are within acceptable chemical and..physical limits for the.....new drug substance and dosage form, and even changes in the..dosage form itself, are likely as..
http://www.fda.gov/cder/guidance/phase1.pdf (score=43)

NDAs: Impurities in Drug Substances (Issued 2/2000, Posted 2/24/2000)
...1 This guidance has been prepared by the Drug Substance Technical Committee of the Chemistry.....considered when evaluating impurities in drug substances produced by chemical syntheses.....2 ICH Q3A defines a new drug substance (also referred to as a new molecular entity or new..
http://www.fda.gov/cder/guidance/3622fnl.pdf (score=43)

Definition of Identity Polymorphism
...Over the years FDA has approved many generic drug products based upon a drug substance with different physical form from.....Polymorphism is often characterized as the ability of a drug substance to exist as two or more.....Polymorphism refers to the occurrence of different crystalline forms of the same drug substance..
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3900B1_04_Polymorphism.htm (score=43)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...For example, micronizing or milling a drug substance and providing greater surface area of the.....Characterization of the chemical and physical properties of the drug substance is one of the.....Therefore, it is appropriate that the physical characteristics of a drug substance be..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=40)

...Systemic exposure patterns reflect both release of the drug substance from the drug product and.....BA data can also provide information indirectly about the properties of a drug substance before.....The pH solubility profile of the drug substance Dissolution profiles generated at different..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=40)

Microsoft Word - 5320.1.doc
...process and validation information for a sterile drug substance is the same as..for a sterile.....6 ONLY if the drug substance is sterile or if..other product quality microbiology issues are.....Description of the manufacturing process for the drug substance, including..sterilization..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=38)

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