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 addition to toxicological considerations, justification of acceptance criteria for the drug.....In general, acceptance criteria for all parameters defining the physicochemical properties should be..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=100)

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 addition to toxicological considerations, justification of acceptance criteria for the drug.....In general, acceptance criteria for all parameters defining the physicochemical properties should be..
http://www.fda.gov/cder/guidance/2180dft.htm (score=100)

Container Closure Systems for Packaging Human Drugs and Biologics
...An adequately detailed description of the tests, methods, acceptance criteria, reference standards.....Tests and acceptance criteria regarding dosage form delivery and container closure system.....Adequate information regarding the tests, methods, acceptance criteria, reference standards, and..
http://www.fda.gov/cder/guidance/1714fnl.htm (score=100)

Guidance for Industry - Container Closure Systems for Packaging Human Drugs...
...An adequately detailed description of the tests, methods, acceptance criteria, reference standards.....Tests and acceptance criteria regarding dosage form delivery and container closure system.....Adequate information regarding the tests, methods, acceptance criteria, reference standards, and..
http://www.fda.gov/cber/gdlns/cntanr.htm (score=100)

Current Good Manufacturing Practices for PET drugs Update
...Acceptance Criteria.. Acceptance Criteria continued.. Labeling and Packaging Controls.. Distribution..
http://www.fda.gov/cder/regulatory/pet/present/cgmpvan/index.htm (score=100)

Current Good Manufacturing Practices for PET drugs Update
...Acceptance Criteria.. Acceptance Criteria continued.. Labeling and Packaging Controls.. Distribution..
http://www.fda.gov/cder/regulatory/pet/present/cgmpvan/ (score=100)

MDI and DPI Drug Products
...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.....considerations, justification of acceptance criteria for the drug substance impurities..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=35)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials.....Justification should be provided for all proposed acceptance criteria included in the drug..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=32)

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...associated acceptance criteria depend on the route of administration of the drug product and the.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials.....Justification should be provided for all proposed acceptance criteria included in the drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=32)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...When describing your acceptance criteria or summary data, we recommend that you include the slope.....Protocol and acceptance criteria for value assignment and validation, including any specific.....data or description of the acceptance criteria applied to address the risks identified in..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=31)

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.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of.....studies, analytical procedures, and acceptance criteria described in your comparability protocol are..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=31)

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.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the impact of.....studies, analytical procedures, and acceptance criteria described in your comparability protocol are..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=31)

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