stability guidance -draft
...Drug substance batches used to produce site-specific drug product batches should be clearly.....analytical profiles of batches of the drug substance and drug product used in the preclinical.....this guidance to mean a batch of drug substance or drug product manufactured at the scale..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=100)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....An alternative approach may be used if such approach satisfies the requirements of the.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=97)

Guidance- Content & Format CMC for Vaccine & Related Product
...and derivatives, or glycolipids, used in purification or production of the drug substance,should be described in detail, including.....A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with.....same areas used to produce the drug substance that is the subject of this application..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=85)

þÿ
...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....Justification for an in-process test that is used in lieu of a drug substance test should.....Information on the reference standards or reference materials used for testing of the drug..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=82)

þÿ
...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....Justification for an in-process test that is used in lieu of a drug substance test should.....Information on the reference standards or reference materials used for testing of the drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=78)

...A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality.....The quality control tests performed on each batch of drug substance, the analytical procedures.....Starting materials of botanical origin that are used to produce a botanical drug substance should be evaluated for..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=74)

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.....sodium hydroxide) used to neutralize excess acid in a synthetic reaction mixture would not..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=74)

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 products as defined.....the potential impact on the biological safety, quality, and purity of the drug substance and/or.....guidance, mAb reagents refers to monoclonal antibodies used as reagents in a drug..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=67)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...The USP also notes that the impurity profile of a drug substance is a description of the.....a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....Related substances are defined as those structurally related to a drug substance such as a..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=49)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....This guideline also does not address the regulation of drug products used during the clinical research.....Safety studies should provide a comparison of results of safety testing of the drug product or drug substance..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=49)

...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be.....In fact, any person who represents that a compounded drug made with a bulk drug substance that appears on this list..
http://www.fda.gov/ohrms/dockets/98fr/010799b.txt (score=45)

WAIS Document Retrieval
...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be.....In fact, any person who represents that a compounded drug made with a bulk drug substance that appears on this list..
http://www.fda.gov/cder/fdama/pclist.txt (score=43)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...Virus or DNA preparations used as preventive vaccines are not covered by this document.....Murphy, HFM-17, Center for Biologics Evaluation and Research, Food and Drug Administration.....Note that if drug substance (defined as bulk product not necessarily in final formulation)and..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=41)

Document
...351, 352, 353a, 355, nominated drug substances is limited, number and size of the bulk.....abstracts from reliable medical sources, substance has been used in pharmacy.. relevant.....through the new drug approval process, Academy of Compounding Pharmacists, rigorous and..
http://www.fda.gov/cder/fdama/pclist.pdf (score=39)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...The areas used for final fill of drug products should follow the recommendations provided.....Purified Bulk Lots (Drug Substance) In addition to lot-to-lot safety testing summarized in.....commonly used in conjunction with mAb for ex vivo manipulations of cellular products..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=37)

...The areas used for final fill of drug products should follow the recommendations provided in the "Guidelines on.....Purified Bulk Lots (Drug Substance) In addition to lot-to-lot safety testing summarized in.....Plasma may be used instead of serum, provided that the anticoagulant used does not affect..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=35)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...the purified drug substance is held prior to further processing, a description of the.....including the data from the material used to prepare clinical/pre-clinical lots and.....include the protocol to be used, number of final lots/serials to be entered into the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=34)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...the purified drug substance is held prior to further processing, a description of the.....including the data from the material used to prepare clinical/pre-clinical lots and.....include the protocol to be used, number of final lots/serials to be entered into the..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=34)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...In either case it is important that the firm compare the drug substance used to manufacturer the bio.....For example, micronizing or milling a drug substance and providing greater surface area of the.....This includes facilities used for development batches and to be used for full-scale..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=32)

GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES
...This would be particularly true for the bulk drug substance manufacturer where reactors and.....The bulk pharmaceutical chemical used to produce the product had become contaminated with.....When such nonsanitary ball valves are used, as is common in the bulk drug industry, the cleaning process is more..
http://www.fda.gov/ora/inspect_ref/igs/valid.html (score=28)

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