ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...procedures and acceptance criteria which, stability of drug substance and drug product. A.....either the drug substance or drug product. product, which may occur during storage, a drug substance should.....A specification is defined as a list of tests, Acceptance Criteria for.. The text of the..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=100)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....considerations, justification of acceptance criteria for the drug substance impurities.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=35)

A:\ESIGRPT1.4PD
...shall include the record of acceptance of critical components,including the acceptance.....Office of Compliance, Center for Biologics Evaluation and Research,Food and Drug.....To accommodate signature alternatives some existing regulations,including the drug CGMP..
http://www.fda.gov/ora/compliance_ref/part11/FRs/background/esigrpt1.pdf (score=33)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=32)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...70, PET centers would have to ensure that each batch of PET drug product meets its established acceptance criteria, except.....71 would require a PET center to reject PET drug products that fail to meet acceptance.....When the receiving facility disposes of the recalled drug, the PET drug producer should obtain a signed..
http://www.fda.gov/cder/guidance/4259dft.htm (score=32)

A:\ESIGRPT1.4PD
...shall include the record of acceptance of critical components,including the acceptance.....Office of Compliance, Center for Biologics Evaluation and Research,Food and Drug.....To accommodate signature alternatives some existing regulations,including the drug CGMP..
http://www.fda.gov/ora/compliance_ref/Part11/FRs/background/esigrpt1.pdf (score=32)

...The Center for Drug Evaluation and Research, in consultation with the Office of the.....However, based upon the outcome of this proposed rule, FDA may extend acceptance of.....The proposed rule to implement certain parts of the PDMA and the Prescription Drug..
http://www.fda.gov/ora/compliance_ref/part11/FRs/background/prrule.txt (score=31)

...The Center for Drug Evaluation and Research, in consultation with the Office of the.....However, based upon the outcome of this proposed rule, FDA may extend acceptance of.....The proposed rule to implement certain parts of the PDMA and the Prescription Drug..
http://www.fda.gov/ora/compliance_ref/Part11/FRs/background/prrule.txt (score=31)

Guidance For Industry Acceptance of Foreign Clinical Studies
...clinical studies in support of an application for marketing approval of a human drug.....FDA is currently reviewing its regulations pertaining to the acceptance of foreign.....Declaration in its regulation governing investigational drug trials conducted in non-U.S..
http://www.fda.gov/cber/gdlns/clinical031301.pdf (score=31)

G:\PRRULE.4PD
...Therefore under the Federal Food, Drug,and Cosmetic Act, and under authority delegated to.....However,based upon the outcome of this proposed rule, FDA may extend acceptance of.....Submit written comments to the Dockets Management Branch(HFA-305), Food and Drug..
http://www.fda.gov/ora/compliance_ref/part11/FRs/background/prrule.pdf (score=31)

G:\PRRULE.4PD
...Therefore under the Federal Food, Drug,and Cosmetic Act, and under authority delegated to.....However,based upon the outcome of this proposed rule, FDA may extend acceptance of.....Submit written comments to the Dockets Management Branch(HFA-305), Food and Drug..
http://www.fda.gov/ora/compliance_ref/Part11/FRs/background/prrule.pdf (score=31)

Acceptance of Foreign Clinical Studies
...FDA is currently reviewing its regulations pertaining to the acceptance of foreign.....Food and Drug Administration (FDA) regulations permit the acceptance of foreign clinical.....This guidance represents the Food and Drug Administration's (FDA's) current thinking on..
http://www.fda.gov/cder/guidance/fstud.htm (score=31)

Guidance for Industry - Acceptance of Foreign Clinical Studies
...FDA is currently reviewing its regulations pertaining to the acceptance of foreign.....Food and Drug Administration (FDA) regulations permit the acceptance of foreign clinical.....drug, biological product, or device if certain conditions are met. Foreign studies..
http://www.fda.gov/cber/gdlns/clinical031301.htm (score=31)

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.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=31)

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.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=31)

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