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.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....A description of the container closure system for the drug substance should be provided.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=55)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....A description of the container closure system for the drug substance should be provided.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=55)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....In the past, applicants have used protocols for container closure system changes, and they.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=46)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....In the past, applicants have used protocols for container closure system changes, and they.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=45)

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.....Container assemblies should be prepared at the beginning of the day before other daily.....When it is determined that all acceptance criteria have been met, the PET center should then provide..
http://www.fda.gov/cder/guidance/4259dft.htm (score=39)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....made to verify that the correct label has been affixed to the container and the shield.....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=36)

Guidance- Content & Format CMC for Vaccine & Related Product
...new lots of reference standards and acceptance criteria for a new reference standard.....A description of the container and closure system, and its compatibility with the drug.....intended to be sterile, evidence of container and closure integrity for the duration of..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=33)

...We recommend that you review the tests, studies, analytical procedures, and acceptance criteria in.....In the past, applicants have used protocols for container closure system changes, and they.....We recommend that you determine whether the tests, studies, analytical procedures, and acceptance..
http://www.fda.gov/cder/guidance/protcmc.doc (score=32)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and tests should be instituted to control those drug substance.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....In addition to toxicological considerations, justification of acceptance criteria for the drug..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=31)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and tests should be instituted to control those drug substance.....In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....In addition to toxicological considerations, justification of acceptance criteria for the drug..
http://www.fda.gov/cder/guidance/2180dft.htm (score=31)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...For example, information would be provided from studies to investigate whether acceptance criteria.....A brief description of the container closure systems listed in P.7 and the container.....Tests and acceptance criteria for microbiological attributes should be included in the specifications..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=31)

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...adequate acceptance criteria to ensure that batches of drug products meet each appropriate.....packaged in semipermeable primary container closure systems, such as low-density.....formulation components or leaching from the container closure system, chemical impurities..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=29)

...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.....A mock or printed representation of the proposed container label that will be provided to..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=29)

stability guidance -draft
...such cases, alternate approaches, such as qualifying higher acceptance criteria for a.....retest date should be placed on the storage container and on the shipping container for a.....If the stability data under the ICH conditions fall outside the acceptance criteria while..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=28)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The acceptance criteria should at a minimum meet the criteria proposed in The Pharmacopeial Forum.63.....In addition, a product filler capable of reproducing an exact fill amount from container to container.....At a minimum, the acceptance criteria should meet the criteriaproposed in the Pharmacopeial Forum.58..
http://www.fda.gov/cder/fdama/difconc.htm (score=28)

...A list of all cellular starting materials, specifically, the acceptance criteria for the cells used.....Container and Closure System Provide a description of the container and closure system.....The stages of cell growth and/or processing should be described in detail including acceptance..
http://www.fda.gov/cber/gdlns/xvcmc.txt (score=26)

...A successful correlation can assist in the selection of appropriate dissolution acceptance criteria.....4 Container Closure System The choice and rationale for selection of the container closure.....For example, information could be provided from studies to investigate whether acceptance criteria..
http://www.fda.gov/cder/guidance/6672dft.doc (score=26)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...Assessment of stability typically includes assaying each active ingredient to meet acceptance.....container, since polymer/foil blisters are not as impervious to moisture as high-density.....Acceptance criteria for process impurities and degradants should be set based on manufacturing..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=26)

Chem Revs. of DMFs for DSIs
...and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances.....Summarize the data showing that the container/closure system is compatible with the drug.....appropriate acceptance criteria that are numerical limits, ranges, or other..criteria for the tests..
http://www.fda.gov/cder/mapp/5015-4.pdf (score=26)

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