PET Drug Products … Current Good Manufacturing Practice (CGMP)
...or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....used if such approach satisfies the requirements of the applicable statutes and.....1 This guidance has been prepared by the PET Steering Committee in the Center for Drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=100)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....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..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....The BPC used to manufacture commercial batches must not significantly differ from that.....On the other hand, finished drug products are usually the result of a formulation from..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=97)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Equipment used in the production, processing, or packaging of a PET drug product should be.....When the receiving facility disposes of the recalled drug, the PET drug producer should obtain a signed.....An alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cder/guidance/4259dft.htm (score=95)

...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.....Section 503A of the act specifically directs FDA to develop a list of bulk drug substances that may be used in..
http://www.fda.gov/ohrms/dockets/98fr/010799b.txt (score=93)

...However, the ultimate responsibility for suitability of equipment used in drug processing rests.....SOFTWARE Software is the term used to describe the total set of programs used by a.....This document is not intended to spell out how to conduct a CGMP drug inspection or set..
http://www.fda.gov/ora/inspect_ref/igs/csd.html (score=91)

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.....Section 503A of the act specifically directs FDA to develop a list of bulk drug substances that may be used in..
http://www.fda.gov/cder/fdama/pclist.txt (score=89)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...including the data from the material used to prepare clinical/pre-clinical lots and.....address during the investigation of a new animal drug and preparation of an.....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=87)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...including the data from the material used to prepare clinical/pre-clinical lots and.....address during the investigation of a new animal drug and preparation of an.....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=87)

þÿ
...that of previous trials used to determine historical evidence of sensitivity to drug.....substantial accumulation of active drug resulting from a long half life of parent drug or.....used at too low a dose or whether the apparently less well-tolerated treatment has been..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=83)

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.....guidance, mAb reagents refers to monoclonal antibodies used as reagents in a drug.....The issues related to mAbs used as reagents are somewhat different from those of mAbs used..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=77)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purposes.....safety and effectiveness of the drug in humans, or if the radioactive drug has a.....A glossary of common terms used in diagnostic medical imaging is provided at the end of..
http://www.fda.gov/cber/gdlns/medimagesaf.pdf (score=75)

Guidance for Industry
...However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purpose.....safety and effectiveness of the drug in humans, or if the radioactive drug has a pharmacological effect in the body,an IND is.....possible, the formulation that will be used for marketing should be used during phase 2..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=99)

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.....commonly used in conjunction with mAb for ex vivo manipulations of cellular products.....entity or is produced by a novel process, and when drug development plans are unusually..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=99)

...The areas used for final fill of drug products should follow the recommendations provided in the "Guidelines on.....Plasma may be used instead of serum, provided that the anticoagulant used does not affect.....Department of Health and Human Services Food and Drug Administration Center for Biologics..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=95)

Document
...number in this manner would, code requirement, and we consider drug doses of the drug.....drugs are used in hospitals, so bar codes errors involving radiopharmaceuticals, bar codes.....Contract printers are commonly used for with bar codes for specified concerns, contracted..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=93)

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.....same areas used to produce the drug substance that is the subject of this application.....A list should be provided of all components in the drug product, including drug substance(s)and other ingredients..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=93)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...should be comparable to the impurity profile of the API batches used in drug safety and.....also identifies CGMPs for the manufacture of APIs used in the production of drug products.....adulterated if the methods used in, or the facilities or controls used for, its manufacture,processing, packing, or holding do..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=91)

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=87)

ICH: Guidance on Viral Safety Eveluation of Biotechnology Products Derived...
...used in the context of the understanding of the biology of the virus and the nature of the.....Food and Drug Administration, AGENCY: Food and Drug Administration, Clearance Officer.....EXAMPLES OF THE USE AND LIMITATIONS OF ASSAYS WHICH MAY BE USED TO TEST FOR VIRUS..
http://www.fda.gov/cber/gdlns/virsafe.pdf (score=87)

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