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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. critical quality standards are chosen to confirm the quality of the drug substance and drug product Important component of quality assurance,	Specification
means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.	"Conformance to specifications"
Dosage forms addressed in this Specification include solid oral dosage forms, liquid oral dosage forms, and parenterals (small and large volume). TRUE OR FALSE	TRUE
the performance of specified tests at release on PRE-SELECTED batches and / or at predetermined intervals, rather than on a batch-to-batch basis with the understanding that those batches not being tested still must meet all acceptance criteria established for that product.	Periodic or Skip Testing
are tests which may be performed DURING THE MANUFACTURE of either the drug substance or drug product, rather than as part of the formal battery of tests which are conducted prior to release.	In-process tests
can be used as an operational ALTERNATIVE to ROUTINE RELEASE testing for the drug product in certain cases when approved by the regulatory authority.	Parametric Release
are those which may be used to measure an attribute when such procedures control the quality of the drug substance or drug product to an extent that is COMPARABLE or superior to the OFFICIAL PROCEDURE.	Alternative Procedures
References to certain procedures are found in pharmacopoeias in each region. Wherever they are appropriate, pharmacopoeial procedures should be utilized.	Pharmacopoeial Tests and Acceptance Criteria
is a substance prepared for use as the STANDARD in an assay, identification, or purity test. It should have a quality appropriate to its use. It is often characterized and evaluated for its intended purpose by additional procedures other than those used in routine testing. For new drug substance __ intended for use in assays, the impurities should be adequately identified and / or controlled, and purity should be measured by a quantitative procedure.	Reference Standard / Reference Material
It is possible that, in addition to release tests, a specification may list in-process tests as defined in 2.3, periodic (skip) tests, and other tests which are not always conducted on a batch-by-batch basis. In such cases the applicant should specify which tests are routinely conducted batch-by-batch, and which tests are not, with an indication and justification of the actual testing frequency.	.
should refer to relevant development data, pharmacopoeial standards, test data for drug substances and drug products used in toxicology and clinical studies, and results from accelerated and long term stability studies, as appropriate. A range of expected analytical and manufacturing variability should be considered may consider theoretical tolerances for a given procedure or acceptance criterion, but the actual results obtained should form the primary basis for whatever approach is taken.	Justification
Test results from stability and scale-up / validation batches, with emphasis on the primary stability batches, should be considered in setting and justifying specifications. TRUE OR FALSE	TRUE
may be helpful in justifying individual acceptance criteria, particularly for assay values and impurity levels.	Presentation of test results in graphic format