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.....stability test storage conditions. Additional studies should be performed to characterize..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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...provided on acceptance criteria, test procedures, and analytical sampling plans(i.e., number of samples tested.....formulation, container closure system, manufacturing,stability, controls of critical steps.....The stability test parameters, with appropriate acceptance criteria, should..include those test parameters identified in the drug..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=29)

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -...
...The stability test parameters, with appropriate acceptance criteria, should include those test parameters identified in the drug.....A validated container closure integrity test, instead of sterility testing, can be used to.....Appropriate, validated test procedures and corresponding acceptance criteria that are reflective of the test results for submitted..
http://www.fda.gov/cder/guidance/4234fnl.htm (score=29)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A full description of the acceptance criteria and the test methods used to ensure the identity, assay, functionality.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on test..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=20)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A full description of the acceptance criteria and the test methods used to ensure the identity, assay, functionality.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....Each source should be assessed, and the material supplied should meet appropriate acceptance criteria based on test..
http://www.fda.gov/cder/guidance/2180dft.htm (score=20)

Guidance for Industry - Container Closure Systems for Packaging Human Drugs...
...Standards or acceptance criteria, test methods, and, where indicated, methods of cleaning, sterilizing, and.....Tests and acceptance criteria regarding dosage form delivery and container closure system functionality should be appropriate to the.....This test measures the water vapor permeation of a single-unit or unit-dose container closure system and establishes acceptance..
http://www.fda.gov/cber/gdlns/cntanr.htm (score=18)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....process test and the drug substance test, the acceptance criterion for the in-process test.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=14)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....process test and the drug substance test, the acceptance criterion for the in-process test.....A description of the container closure system for the drug substance should be provided..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=14)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...When the quality control unit has determined that a lot of material has met all acceptance criteria.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive for microbial growth, a complete.....Container assemblies should be prepared at the beginning of the day before other daily..
http://www.fda.gov/cder/guidance/4259dft.htm (score=10)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....of false-positive results arises in the sampling and transfer of the test aliquot from the.....made to verify that the correct label has been affixed to the container and the shield..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=9)

...This can be accomplished by examining and/or testing to ensure that the acceptance criteria are met.....A copy of the container label and the immediate outer carton label of the marketed product.....We recommend that this test be performed for crude extracts from natural sources..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=8)

stability guidance -draft
...acceptance criteria of such parameters, and the test methodology used to assess such.....including evaluation of the container and closure integrity by appropriate challenge test.....such cases, alternate approaches, such as qualifying higher acceptance criteria for a..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=7)

Guidance for Industry
...regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic.....deviation is considered to have compromised the integrity of the sterility test, the test.....In an aseptic process, the drug product, container, and closure are first subjected to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=6)

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
...criteria that are numerical limits, ranges, or other criteria for the test described. 1842.....container. For example, if the API is marketed in bags within fiber drums, 1028.....25 Acceptance criteria for residues and the choice of cleaning procedures and.. 397..
http://www.fda.gov/cder/guidance/4011dft.pdf (score=6)

Guidance for Industry
...Each medical gas container and closure, upon receipt and before acceptance, must be.....We recommend that an individual responsible for performing an odor test not have an.....container and attached it to the container containing argon, and was able to fill the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=6)

Compliance Program - Inspection of Plasma Derivatives of Human Origin, 7342.006
...Individual manufacturers may have additional, self-imposed acceptance criteria, and these must be met.....Compare raw test data against test results provided in protocols submitted to CBER to ensure that they.....Ensure that the firm has stability programs for final container products and that they..
http://www.fda.gov/ora/cpgm/42_006.html (score=6)

Compliance Program Guide - Inspection of Plasma Derivatives of Human Origin,...
...Individual manufacturers may have additional, self-imposed acceptance criteria, and these must be met.....Compare raw test data against test results provided in protocols submitted to CBER to ensure that they.....Ensure that the firm has stability programs for final container products and that they..
http://www.fda.gov/cber/cpg/7342006bld.htm (score=6)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...Finally, a finished drug product odor test must be performed on each container undergoing.....acceptance criteria, and the course of action to be taken if test results fall outside of established.....This would pertain to any container or closure used to deliver industrial products, any..
http://www.fda.gov/cder/dmpq/freshair.htm (score=6)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...Upon receipt and before acceptance, each container or grouping of containers of raw.....Deviations from written specifications, standards,sampling plans, test procedures, or.....the batch selection criteria and analytical data that will be evaluated to determine..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=5)

CBER Annual Report FY2003
...acceptance criteria for source organs, criteria for islet isolation/processing, product potency and.....The newly approved HIV test is called the OraQuick Rapid HIV-1 Antibody Test, manufactured.....FDA’s new policy would combine, simplify and update regulations related to blood container..
http://www.fda.gov/cber/inside/annrpt.htm (score=5)

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